the Package Insert
Contents
1. AAAA KK KK kuu l pp VVVV KK PP VVVV KK kuukauden loppuun menness AAAA MM JJ AAAA MM MM fin du mois JJJJ MM TT JJJJ MM MM Monatsende EEEE MM HH EEEE MM MM r Aog rou priva EEEE HH NN EEEE HH HH h nap utols napja AAAA MM GG AAAA MM MM fine mese MMMM MM DD MMMM MM MM m nesio pabaiga AAAA MM DD AAAA MM MM slutten av m neden RRRR MM DD RRRR MM MM koniec miesi ca AAAA MM DD AAAA MM MM fim do m s RRRR MM DD RRRR MM MM koniec mesiaca aaaa mm dd aaaa mm mm fin del mes AAAA MM DD AAAA MM MM slutet pa manaden TTTT MM AJ FTTT MM MM kpas Ha meceya AAAA LL ZZ AAAA LL LL sf r itul lunii YYYY AA GG YYYY AA AA ayin sonu GGGG MM DD GGGG MM MM kraj meseca TTTT MM J FTTT MM MM kone mecaua 4OIOIOK AA KK XOIOIOK AA AA a AbiH CoHb GGGG MM DD GGGG MM MM kraj mjeseca Catalog number Katalogov slo Katalognummer Catalogusnummer Kataloogi number Tuotenumero Num ro catalogue Bestellnummer Api8u c karaA you Katal gussz m Numero di catalogo Katalogo numeris Numer katalogowy Numero do cat logo Katal gov slo N mero de cat logo KaranoxeH Homep Num r de catalog Katalog numarasi Kataloski broj Homep no katanory Karanor Hemipi Authorized Representative in the European Community Autorizovany z stupce pro Evropskou unii Autoriseret repr sentant i E2. Kerayspdiva Date de pr l vement Entnahmedatum Hyepoynvia cuMoyfic Mintav tel ideje Data prelievo Pa emimo data Dato provetaking Data pobrania Data da colheita D tum odberu Fecha de coleccion Uppsamlingsdatum Dara Ha ce6upaue Data colect rii Toplama tarihi Datum prikupljanja Dara c6opa Kunarau ris6ekyui Dani sakupljanja Patient ID number ID pacienta Patient ID nummer Identificatienummer van de pati nt Patsiendi ID Potilaan tunnusnumero Num ro d identification du patient Patienten ID ApiGu c unrpuou ao evo Beteg azonos t sz ma Numero di identificazione paziente Paciento identifikavimo numeris Pasientens ID nummer Numer ID patentu N meroda ID do doente Identifika n slo pacienta N mero de identificaci n del paciente Patientens ID nummer WI Homep Ha nauueura Num r ID pacient Hasta kimlik numaras ID broj pacijenta MaeurudukauyonHelit HoMep nauyeura llauneurriu ngentnounkaynanbik Hemipi Identifikacijski broj pacijenta 21 ES 23 This product is sold under license and purchase of this product does not include rights to use for certain blood and tissue screening applications nor for certain industrial applications Ce produit est vendu sous licence L achat de ce produit ne conf re aucun droit relatif l utilisation de certaines applications de d pistage sur des tissus et du sang ni certaines applications industrielles Dieses Pr
3. di sterilizzazione irradiazione Sterilizavimo b das radiacija Steriliseringsmetode bestr ling Metoda sterylizacji napromienianie M todo de esteriliza o irradia o Met da steriliz cie o iarenie M todo de esterilizaci n irradiaci n Steriliseringsmetod str lning Metog Ha crepunusauus upaguauna Metod de sterilizare iradiere Sterilizasyon y ntemi irradyasyon Metoda sterilizacije ozra avanje Meron crepunuasauww o6nyueuve Crepunusayna enici ceyne rycipy Metoda sterilizacije zracenje iridacija Manufacturer V robce Producent Fabrikant Tootja Valmistaja Fabricant Hersteller Karaokeuaorrjc Gy rt Ditta produttrice Gamintojas Producent Fabricante V robca Tillverkare Npoussoguten Produc tor retici Proizvo a Npoussogutenb ATrkapyuibl Use by Spotrebujte do Anvendes for Houdbaar tot Kasutada enne Viimeink ytt p iv A utiliser avant Verwendbar bis Huepoyn a Arj amp nc Felhaszn lhat s g d tuma Usare entro Naudokite iki Brukes for Stosowa do Utilizar em Pou ite do Usar antes de Anv nd f re Manonssaitre no A se utiliza pana la Son kullanma tarihi Upotrebiti do Ucnonb30BaTb ao neiin naigananyra Upotrijebiti do YYYY MM DD YYYY MM MM end of month RRRR MM DD RRRR MM MM Konec m s ce AAAA MM DD AAAA MM MM slutning af m ned JJJJ MM DD JJJJ MM MM einde maand AAAA KK PP
4. ec xprjonc Olvassa el a haszn lati utas t st Consultare le istruzioni per l uso Skaitykite naudojimo instrukcijas Se i bruksanvisningen Zobacz instrukcja u ytkowania Consulte as instru es de utiliza o Pozri Pokyny na pou vanie Consultar las instrucciones de uso Se bruksanvisningen Hanpaaere cnpaBka B wHcrpykuuure 3a ynorpe 6a Consulta i instruc iunile de utilizare Kullan m Talimatlari na ba vurun Pogledajte uputstvo za upotrebu CM pykogoacTeo no akcnnyataynn llananaHy HyckaynbifbIMeH TaHbICbIN anbiHbI3 Koristi upute za upotrebu Negative control Negativn kontrola Negativ kontrol Negatieve controle Negatiivne kontroll Negatiivinkontrolli Contr le n gatif Negative Kontrolle Apvnrik c Aeyxoc Negat v kontroll Controllo negativo Neigiama kontrol Negativ kontroll Kontrola ujemna Controlo negativo Negat vna kontrola Control negativo OrpuuareneH KoHTpon Etalon negativ Negatif kontrol Negativna kontrola OrpuuarenkHeiit KOHTponb Heratustik 6akeinay Peel Otev ete zde Abnes her Afpellen Koorida Veda D coller Abziehen X uBoAo arrok Minong H zza le Strappare per aprire Pl sti Cia Trekke av Oderwa Destac vel Odtrhnite Desprender Drag is r O6enerte Se dezlipeste Ay rma Oljustiti Orknewre Ycriuri KabaTbIH anbin tacta Otvoriti skini Collection date Datum odb ru Opsamlingsdato Afnamedatum Kogumiskuup ev
5. 15 2 27 4 14 4 2 8 9 9 gt 25 6 112 735 26 95 18 125 4 142 7 71 32 125 EE 13 8 28 6 27 4 144 2 8 6 5 25 0 agina 116 838 16 56 26 96 18 125 4 1142 11 169 32 128 En GA 13 5 24 7 23 9 15 6 3 8 6 5 24 4 DEER 134 995 24 97 27 113 24 154 8 213 11 170 31 127 B Positive and Negative Predictive Value Hypothetical positive and negative predictive values PPV and NPV for the TV Q Assay are shown in Table 7 These calculations are based on hypothetical prevalence and overall sensitivity and specificity per specimen type as determined in the clinical trial for each specimen type Table 8 For the TV Q Assay these calculations are based upon an overall sensitivity and specificity of 95 5 and 98 7 respectively for the neat urine specimen type 98 3 and 99 0 respectively for the vaginal swab specimen type and 96 3 and 99 4 respectively for the endocervical swab specimen type PPV was calculated using Sensitivity x Prevalence Sensitivity x Prevalence 1 Specificity x 1 Prevalence NPV was calculated using Specificity x 1 Prevalence 1 Sensitivity x Prevalence Specificity x 1 Prevalence Table 7 Prevalence vs Hypothetical Predictive Values for TV Q Assay PERFORMANCE CHARACTERISTICS First void urine specimens between 20 60 mL self collected vaginal swabs in a clinical setting and clinician collected endocervical swabs were collected from 1222 symp
6. BD n edustajaan ohjeiden saamiseksi ETIKOIVWV OTE pE Tov TOTIIK AVTITIPOOWTTO me BD yia o ny z A haszn lati utas t st k rje a BD helyi k pviselet t l Hyckaynap vun xeprinikri BD exinimeH xa6apnacbineis Naudojimo instrukcij teiraukit s vietos BD galiotojo atstovo Kontakt din lokale BD representant for mer informasjon Aby uzyska instrukcje u ytkowania skontaktuj si z lokalnym przedstawicielstwem BD Contacte o representante local da BD para instru es Pentru instruc iuni contacta i reprezentantul local BD na nonyyenua ykazann o6parurecb K MecTHOMY npeacraBurenio Komnauun BD Obratite se svom lokalnom predstavniku kompanije BD za uputstva In trukcie z skate u miestneho z stupcu spolo nosti BD Kontakta n rmaste BD representant f r anvisningar Talimatlar i in yerel BD temsilcinizle temasa ge in INTENDED USE The BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay when tested with the BD Viper System in Extracted Mode uses Strand Displacement Amplification technology for the direct qualitative detection of Trichomonas vaginalis DNA in clinician collected female endocervical swab specimens patient collected vaginal swab specimens in a clinical setting and female urine specimens The assay is indicated for use with asymptomatic and symptomatic females to aid in the diagnosis of trichomoniasis SUMMARY AND EXPLANATION Vaginal infections caused by Trichomonas va
7. Distributions A total of 2568 TV Or Assay results were evaluated at 7 geographically diverse clinical sites A frequency distribution of the initial MaxRFU values for the TV Q Assay for the Neat urines vaginal and endocervical swab specimens is shown in Figures A C The distribution of MaxRFU values from TV Q true positive TP true negative TN false positive FP and false negative FN specimens i e from those specimens that yielded results which were discordant with the composite reference methods of wet mount and TV culture is shown in Table 10 Any MaxRFU value below 125 is considered negative for TV while MaxRFU values 2125 are considered positive for TV 11 Figure A MaxRFU Distribution for Neat Urine Frequency 0 49 50 99 100 124 125 149 150 199 200 249 250 349 350 499 500 799 gt 800 MaxRFU Figure B MaxRFU Distribution for Vaginal Swab Specimen 8004 6007 4004 Frequency 200 0 49 50 99 100 124 125 149 150 199 200 249 250 349 350 499 500 799 gt 800 MaxRFU Figure C MaxRFU Distribution for Endocervical Swab Specimen Frequency 0 49 50 99 100 124 125 149 150 199 200 249 250 349 350 499 500 799 gt 800 MaxRFU 12 Table 10 MaxRFU ranges for FN FP TN and TP SE E EE SES RS EES e E ET REN GE NN REOS a a EE EE KEE TEE EE ET EEN LE T ET TEEN EE E ET TEE E TEE EE EEN E EE EC EE EECH N EE ERST AN RECETTE ECRIRE EE EEN EE NEIN NS H EH gens EE E
8. TABLES Symbols and Abbreviations Symbols positive negative number percentage Abbreviations A Asymptomatic CI Confidence Interval CV Coefficient of Variation CFU Colony Forming Units EC Extraction Control ET Extraction Transfer Error FN False Negative FP False Positive HIV Human Immunodeficiency Virus l Indeterminate LBC Liquid Based Cytology LOD Limit of Detection MaxRFU Maximum relative fluorescent units N Negative n number NA non applicable NAAT Nucleic Acid Amplification Test NPA Negative Percent Agreement NPV Negative Predictive Value OB GYN Obstetrics Gynecology P Positive PBS Phosphate Buffered Saline PCR Polymerase Chain Reaction PIS Patient Infected Status PPA Positive Percent Agreement PPV Positive Predictive Value QC Quality Control S Symptomatic SDA Strand Displacement Amplification StD Standard Deviation STD Sexually Transmitted Disease TN True Negative TP True Positive vp viral particles 18 AVAILABILITY The following BD ProbeTec TV Q and BD Viper products are also available Cat No Description 440724 BD Viper Pipette Tips 960 441392 BD Viper Trash Box 441391 BD Viper Trash Bags 440818 BD Viper Trash Boxes and Bags 440974 BD Viper Tube Lockdown Cover 440975 BD Viper Lysing Heater 115V 440976 BD Viper Lysing Heater 230V 440977 BD Viper Lysing Rack 440984 BD Viper Amplification Plate Sealers Black 441072 BD Viper Liqui
9. TV cultures were transported to the assigned testing facility The BD ProbeTec neat urines vaginal and endocervical swab specimens were transported to one of the three BD Viper testing laboratories where they were tested using the BD ProbeTec TV Or Assay on the BD Viper System in Extracted Mode All sensitivity and specificity calculations were based on the total number of BD ProbeTec TV Q Assay results for the neat urines vaginal and endocervical specimens as compared to the composite reference of the wet mount and the commercially available TV culture test method The subject was considered to be positive for Trichomonas vaginalis if either the wet mount or TV culture result was positive Subjects were considered negative for Trichomonas vaginalis if both of the reference methods were negative The sensitivity and specificity by specimen type and symptomatic status for the compliant TV Q Assay PIS evaluable subjects are seen in Table 8 The initial instrument error rate during the clinical study was 0 196 or 3 indeterminate results out of 2 568 tests The final error rate after repeat testing performed on indeterminate results was 0 04 or 1 indeterminate result out of 2 568 tests Table 8 TV Q Assay Performance Compared to Composite Reference by Symptomatic Status Performance Compared to Composite Reference Specimen Gite D Sensitivity 95 CL Specificity 93 196 27 29 78 096 98 196 99 6 259 260 97 9 99 9 Neat Urine 96 4
10. not exceed 2 min Thoroughly rinse the rack with water and allow to air dry Clean the entire work area counter tops and instrument surfaces with 396 w v hydrogen peroxide do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days 196 v v sodium hypochlorite or DNA AWAY on a daily basis Thoroughly rinse with water Allow surfaces to dry completely before proceeding with additional testing Contact BD Technical Services in the event of an unusual situation such as a spill into the BD Viper instrument or DNA contamination that cannot be removed by cleaning Store reagents at the specified temperature and do not use them after the expiration date SWAB SPECIMEN COLLECTION STORAGE TRANSPORT AND PROCESSING Endocervical Swab Specimen Collection Endocervical swab specimens should be collected using the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens NOTE All specimens should be obtained from the patient by appropriately trained individuals o O NOOO d ox c Remove the white cleaning swab from packaging Using white cleaning swab remove excess blood and mucus from the cervical os Discard the used white cleaning swab Remove the pink collection swab from packaging Insert the pink collection swab into the cervical canal and rotate for 15 30 s Withdraw the pink collection swab carefully Avoid contact with the vaginal mucosa Uncap the Q Swab Diluent Tube Fully in
11. the extracted solution to the optimum for amplification of the target The BD ProbeTec TV Q Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently labeled detector probe The reagents for SDA are dried in two separate disposable microwells the Priming Microwell contains the amplification primers fluorescently labeled detector probe nucleotides and other reagents necessary for amplification while the Amplification Microwell contains the two enzymes a DNA polymerase and a restriction endonuclease that are required for SDA The BD Viper System pipettes a portion of the purified DNA solution from each Extraction Tube into a priming microwell to rehydrate the contents After a brief incubation the reaction mixture is transferred to a corresponding pre warmed amplification microwell which is sealed and then incubated in one of he two thermally controlled fluorescent readers The presence or absence of T vaginalis DNA is determined by calculating he peak fluorescence Maximum Relative Fluorescent Units MaxRFU over the course of the amplification process and by comparing this measurement to a predetermined threshold value In addition to the fluorescent probe used to detect amplified T vaginalis target DNA a second fluorescently labeled oligonucleotide is incorporated in each reaction The Extraction Control EC oligonucleotide is labeled with a different dye than that
12. used for detection of the T vaginalis specific arget and is used to confirm the validity of the extraction process The EC is dried in the Extraction Tubes and is re hydrated upon addition of the specimen and extraction reagents At the end of the extraction process the EC fluorescence is monitored by the BD Viper instrument and an automated algorithm is applied to both the EC and T vaginalis specific signals 0 report specimen results as positive negative or EC failure When analyzing the TV Q Assay for T vaginalis DNA an aliquot of the eluate will be removed and transferred to a blank microwell When analyzing for CT GC TV CT TV or GC TV an aliquot of the eluate will be removed and transferred to the first non TV microwell This provides the EC result for the TV Q Assay The process flow requires an additional dilution step o allow for eluate transfer to the TV Q Priming Microwell REAGENTS Each BD ProbeTec TV Q Assay Reagent Pack contains BD ProbeTec TV Q Amplified DNA Assay Priming Microwells 12 x 96 1152 test kit or 4 x 96 384 test kit each Priming Microwell contains approximately 123 pmol oligonucleotides 54 pmol fluorescently labeled detector probe 80 nmol dNTPs with stabilizers and buffer components BD ProbeTec TV Q Amplified DNA Assay Amplification Microwells 12 x 96 1152 test kit or 4 x 96 384 test kit each Amplification Microwell contains approximately 25 units of DNA polymerase and 62 units restriction enzyme wi
13. 80 83 89 9 98 8 98 1 356 363 96 1 99 1 95 5 107 112 90 0 98 1 98 7 615 623 97 5 99 3 93 5 29 31 79 3 98 2 99 0 309 312 97 2 99 7 Vaginal 100 0 85 85 95 7 100 0 99 0 406 410 97 5 99 6 98 3 114 116 93 9 99 5 99 0 715 722 98 0 99 5 92 2 47 51 81 5 96 9 99 1 450 454 97 8 99 7 Endocervical 98 8 82 83 93 5 99 8 99 8 406 407 98 6 100 0 96 3 129 134 91 6 98 4 99 4 856 861 98 6 99 8 92 8 103 111 86 4 96 3 99 2 1018 1026 98 5 99 6 All Specimen Types 98 4 247 251 96 0 99 4 99 0 1168 1180 98 2 99 4 Combined 96 7 350 362 94 3 98 1 99 1 2186 2206 98 6 99 4 ET asymptomatic C I confidence interval n number S symptomatic Of the five neat urine Viper negative composite reference positive one was also negative by alternate NAAT test Of the eight neat Viper positive composite reference negative six were also positive by alternate NAAT test Of the seven vaginal Viper positive composite reference negative four were also positive by alternate NAAT test D Of the two endocervical Viper positive composite reference negative both were also positive in at least one specimen tested by alternate NAAT test Table 9 shows the sensitivity specificity PPV and NPV of the TV Q Assay by specimen type and collection site 10 Table 9 TV Q Assay
14. Control Set for the BD ProbeTec CT GC TV Q Amplified DNA Assays is provided separately One Positive and one Negative Control must be included in each assay run and for each new reagent kit lot number Controls must be positioned according to the BD Viper Instrument User s Manual The CT GC TV Or Positive Control will monitor for substantial reagent failure only The CT GC TV Q Negative Control monitors for reagent and or environmental contamination The CT GC TV Q Positive Control comprises recombinant plasmids that contain the SDA target regions for the CT Q GC Q and TV Q Assays The plasmids are not necessarily representative of native target DNA detected by the assay e g their overall length is shorter than that of the complete gene or genomic sequence nor are the controls representative of the specimen matrices indicated for use with the assays on the BD Viper System in extracted mode The Positive Control when it is rehydrated by the BD Viper System contains approximately 2400 copies per mL of pCTB4 and pGCINTS as well as approximately 4000 copies per mL of pTVAP651 linearized plasmids The TV Q Negative Control comprises the same milieu as the Positive Control but without the plasmid DNA The Positive and Negative Control formulations are dried in separate 4 5 mL specimen tubes A QC pair Positive Control and Negative Control must be logged in for each plate to be tested and for each reagent kit lot number The location of the microw
15. E E E EE TEE Ge se d sim egeo ede eer FN false negative FP false positive TN true negative TP true positive n number D Controls During the clinical evaluation there were no CT GC TV Q Positive Control Failures from 235 TV Q runs For the CT GC TV Q Negative Control there was 1 CT GC TV Q Negative control failure from the 235 TV Q runs The CT GC TV Or Positive and Negative Control MaxRFU values observed in the clinical trial are shown in Table 11 Table 11 CT GC TV Q Control Information MaxRFU 4 n 95th Negative Control 234 0 56 Lo n Positive Control 724 2304 1419 1960 n number 13 PERFORMANCE CHARACTERISTICS Table 12 Analysis of TV Positive Negative Specimens from Subjects as Compared to Composite Reference EE T roc Symptomatic PIS Wet Mount TV Culture Vaginal Endocervical NeatUrine Yes Me Total i T i z za gt BR A i i N o T z i d i 4 hi TTE M Wm lt lt In LN LN Iw j NA j N jo j 3 j 1 OS PIS patient infected status P positive N negative NA Not Available ANALYTICAL PERFORMANCE TV O Assay Analytical Sensitivity The analytical sensitivity Limit of Detection or LOD for the BD ProbeTec TV Q Assay was determined for two strains of T vaginalis one Metronidazole sensitive and one Metronidazole resistant by diluting in specimen matrix at varying concentrations
16. Performance Compared to Wet Mount and TV Culture Composite Reference Result by collection site Performance Compared to Composite Reference EE o Sieg Gem tou Es ee ee e Ke 0 0 umo PEU ee Neat Urine pos 20 142 SR 10909 ation pu 80 0 100 0 ENEXUONB BE NE NE NEECXES ee Dmm pe Em Deep 100 0 100 0 99 1 4 qam uer mer 100 0 25 99 3 SL LE me m pm T mum pee BEER T ER pen mx p mem p mm p mm an ee 91 7 74 2 100 0 95 0 ZTS 22 24 97 795 73 73 100 0 00 06 978 7 00 0 67 5 100 0 05 7 Es SEN 27 27 00 0 86 86 100 0 GE 90 078 95 8 79 8 100 0 07 1 135 23 24 99 3 130 130 100 0 00 0 99 2 Endocervical 99 4 100 0 00 0 60 6 100 0 01 2 2500 16 16 00 096 40 40 400 0 100 0 00 0 67 1 100 0 04 8 SI 96 26 26 00 0 70 70 100 0 100 0 94 4 74 2 98 1 03 4 144 17 18 99 0 105 107 99 5 89 5 Vaginal 00 0 67 6 98 0 95 1 a e Les 8 8 00 0 201 205 99 296 Se reta 81 896 52 396 100 096 97 6 5 o 9 11 94 9 159 159 100 0 1000 98 8 00 0 70 1 100 0 96 7 e ree qu 9 9 00 0 112 112 100 0 00 075 100 078 00 0 89 0 99 0 94 3 rae 31 31 00 0 95 96 99 8 969 7100979 C I confidence interval n number NPV negative predictive value PPV positive predictive value Prev prevalence Spec specimen C MaxRFU Frequency
17. Revisions BALTSO0191 Version 7 0 Template 4 NOTES 1 BD Catalog Number 441917 Blank Sheet Size Length 8 5 width 11 Number of Pages 24 Number of Sheets 6 Page Size Length 8 5 Width 5 5 Final Folded Size 5 5 x 8 5 Ink Colors No of Colors 1 PMS Standard Black Printed two sides Yes No Style see illustrations below 5 j HEADER HEADER 1 2 HEADER ER a TT W IE c rI 8 See specification control no BALT8089063 for material information 9 Graphics are approved by Becton Dickinson and Company Supplier has the responsibility for using the most current approved revision level Label Design Date COMPANY CONFIDENTAL THIS DOCUMENT IS Ne BD Becton Dickinson and Company THE PROPERTY OF BECTON DICKINSON AND C THE COMPANY WITHOUT WRITTEN PERMISSION Sparks MD 21152 USA Checked By Date Category and Description Sheet 1 of 25 Package Insert rr A Part Number amp BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay English pages 1 19 C gar 441917 443433 CBrpxere ce c MecrHMsi npencraBurern Ha BD 3a unctTpyks3un Kontaktiraj lokalnog predstavnika BD za upute Pokyny vam poskytne m stn z stupce spole nosti BD Kontakt den lokale BD repraesentant for at fa instruktioner Neem contact op met uw plaatselijke BD vertegenwoordiger voor instructies Kasutusjuhiste suhtes kontakteeruge oma kohaliku BD esindajaga Ota yhteys l himp n
18. S Department of Health and Human Services 2007 Biosafety in microbiological and biomedical laboratories HHS Publication CDC 5th ed U S Government Printing Office Washington D C Directive 2000 54 EC of the European Parliament and of the council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work seventh individual directive within the meaning of Article 16 1 of Directive 89 391 EEC Official Journal L262 17 10 2000 p 0021 0045 19 sreRiLE eo Do not reuse Nepou vejte opakovan Ma ikke genbruges Niet opnieuw gebruiken Mitte kasutada korduvalt Ei saa k ytt uudelleen Usage unique Nicht wiederverwenden Mnv ro amp avaxpnoiporroie re Egyszer haszn latos Non riutilizzare Tik vienkartiniam naudojimui Ma ikke gjenbrukes Nie stosowa powt rnie Nao reutilizar Nepou vajte opakovane No reusar Far ej teranv ndas He usnonssaiite orHoBo A nu se reutiliza Tekrar kullanmay n Ne upotrebljavajte ponovo He wcnone3oBarb noBTopHo llaqanan6aHneis Ne koristiti ponovo Method of sterilization irradiation Zp sob sterilizace z en Sterilisationsmade Bestr ling Sterilisatiewijze bestraling Steriliseerimismeetod kiirgus Sterilointimenetelm s teilytys M thode de st rilisation irradiation Sterilisationsmethode Bestrahlung M 80d0 aroort puong akrivoBoA a Steriliz l s m dszere besug rz s Metodo
19. U Erkend vertegenwoordiger in de Europese Unie Volitatud esindaja Euroopa N ukogus Valtuutettu edustaja Euroopan yhteis ss Repr sentant agr pour la C E E Autorisierte EG Vertretung E ouociobornp vog avrirrp ourrog ornv Eupurraikrj Koivotnta Hivatalos k pviselet az Eur pai Uni ban Rappresentante autorizzato nella Comunit europea galiotasis atstovas Europos Bendrijoje Autorisert representant i EU Autoryzowane przedstawicielstwo w Unii Europejskiej Representante autorizado na Uni o Europeia Autorizovan z stupca v Eur pskom spolo enstve Representante autorizado en la Comunidad Europea Auktoriserad representant i EU Oropuaupan npegctasuten B EU Reprezentant autorizat n Uniunea European Avrupa Toplulu u Yetkili Temsilcisi Ovla eni predstavnik u Evropskoj zajednici YnonHomoyseHHbi npeacraBurenb B Egpone ckom coo6uiecrae Espona KaybiIMgacTbiFbiHgarb yekinerri exin Autorizuirani predstavnik u EU In Vitro Diagnostic Medical Device L ka sk za zen ur en pro diagnostiku in vitro In vitro diagnostisk medicinsk anordning Medisch hulpmiddel voor in vitro diagnose In vitro diagnostika meditsiiniaparatuur L kinn llinen in vitro diagnostiikkalaite Dispositif m dical de diagnostic in vitro Medizinisches In vitro Diagnostikum In vitro iayvwoT k rarpikrj cuokeur In vitro diagnosztikai orvosi eszk z Dispositivo medico diagnostico in vitro In vitro diagnosti
20. amples were removed from storage and tested with the BD ProbeTec TV Q Assay on the BD Viper System in extracted mode Twenty four assay replicates were generated for each condition sample type temperature duration Vaginal Dry and Expressed Swab Stability Pools of TV negative vaginal swab matrix were used in analytical experiments to support the storage and transport stability claims for dry vaginal swab specimens Pools were spiked with TV strain ATCC 30001 to give 222 trichomonads mL 3x LOD when seeded onto swabs and expressed in Q Swab Diluent Seeded dry swabs were stored at 2 8 C for up to 14 days or at 30 C for up to 3 days or at 20 C for up to 180 days At each time point dry swabs were removed from storage and expressed into 2 mL of Q Swab Diluent and evaluated with the BD ProbeTec TV Q Assay on the BD Viper System in extracted mode Twenty four assay replicates were generated for each condition sample type temperature duration Pools of TV negative vaginal swab matrix were used in analytical experiments to support the storage and transport stability claims for expressed vaginal swab specimens Pools were spiked with TV strain ATCC 30001 to give 222 trichomonads mL 3x LOD The spiked swab matrix was stored at 2 8 C or 30 C for up to 30 days or at 20 C for up to 180 days At each time point samples were removed from storage and evaluated with the BD ProbeTec TV Q Assay on the BD Viper System in extracted mo
21. b carefully from the Q Swab Diluent Tube to avoid splashing Place the expressed swab back into the transport tube and discard with biohazard waste Tightly recap the Q Swab Diluent Tube with the black pierceable cap Repeat steps 1 6 for additional swab specimens Using the tube layout report place the tube in order in the BD Viper Lysing Rack and lock into place 095 AO En eco 9 Specimens are ready to be pre warmed 10 Change gloves before proceeding to avoid contamination URINE SPECIMEN COLLECTION STORAGE TRANSPORT AND PROCESSING Performance for female urine specimens has been established with urine collected in a sterile plastic preservative free specimen collection cup i e neat urine without preservatives Performance with other collection devices has not been established Urine Specimen Collection 1 The patient should not have urinated for at least 1 h prior to specimen collection 2 Collect the specimen in a sterile preservative free specimen collection cup 3 The patient should collect the first 20 60 mL of voided urine the first part of the stream NOT midstream into a urine collection cup 4 Cap and label with patient identification and date time collected Neat Urine Storage and Transport Store and transport neat urine specimens from the collection site to the test site at 2 8 C and pre warm them within 7 days of collection Neat urine that is not refrigerated at 2 8 C after colle
22. control failures which caused a reduction in the full number of replicates at one test site zx 72 88 N e co o AR N p a w N E 100 0 95 9 90 90 100 0 GE e Luo om vo High Negative 39 3 29 8 Urine 0 3XLOD lassar 49 7 976 96 913 87 93 54 SS oa 0 00 System Cross Contamination and Carryover An internal study was conducted to evaluate the risk of producing a false positive result with the TV Q Assay protocol in either the same run on the BD Viper System in Extracted Mode within run cross contamination or in a subsequent run between run carryover Testing was conducted using negative and positive samples on three BD Viper Systems Positive samples were seeded with a representative analyte 10 CT EBs mL Two runs with alternating positive and negative samples arranged in the sample rack in a checkerboard pattern at a positivity rate of 5096 were performed on each BD Viper System followed by a third run on each BD Viper System with negative samples This sequence was repeated twice to determine the combined rate of crossover and carryover contamination The overall rate of contamination was 0 49956 3 612 in TVQ mode and 30 3996 3 807 in CTQ GCQ TVQ panel mode login mode in which a single sample tube may be tested with the CT Q GC Q and TV Q Assays on the BD Viper System See BD Viper Instrument User s Manual for more information on the CTQ GCQ TVQ mode 17 INTERPRETATION OF
23. ction stored at temperatures up to 30 C must be pre warmed and processed within 24 h of collection Neat urine specimens may also be stored frozen at 20 C for up to 180 days prior to pre warming Table 2 Neat Urine Processing Procedure NOTE Wear clean gloves when handling the urine specimen If gloves come in contact with specimen immediately change to prevent contamination of other specimens If specimens are refrigerated or frozen make sure they are brought to room temperature and mixed by inversion prior to proceeding 1 Label a Specimen Tube for use on the BD Viper System Extracted Mode with the patient identification and date time collected 2 Swirl the urine cup to mix the urine specimen and open carefully NOTE Open carefully to avoid spills which may contaminate gloves or the work area 3 Uncap the neat urine tube and use a pipette to transfer the urine specimen into the tube The correct volume of urine has been added when the fluid level is between the purple lines on the fill window located on the label This volume corresponds to approximately 2 0 3 0 mL of urine DO NOT overfill or under fill the tube Tighten a black pierceable cap securely on each tube Repeat steps 1 4 for each urine specimen Use a new pipette or pipette tip for each sample Using the tube layout report place the neat urine specimens in order in the BD Viper Lysing Rack and lock into place Specimens are ready to be pre warmed Chan
24. d Waste Bottle 441074 BD Viper Plate Seal Tool 440752 Microwell Package for the BD Viper System 441091 BD Viper System 441917 BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay Reagent Pack 1152 tests 443433 BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay Reagent Pack 384 tests 441925 Control Set for the BD ProbeTec CT GC TV Q Amplified DNA Assays 24 positive and 24 negative 441128 BD Viper Extraction Reagent and Lysis Trough 12 Extraction Reagent Troughs and 12 Lysis Troughs 441129 BD FOX Extraction Tubes 441354 BD Viper Neutralization Pouch 12 pouches 441357 BD ProbeTec Or Collection Kit for Endocervical or Lesion Specimens 100 units 441359 Caps for use on the BD Viper Extracted Mode 4 x 100 441360 Specimen Tubes and Caps for use on the BD Viper Extracted Mode 4 x 100 441361 Swab Diluent for the BD ProbeTec Q Amplified DNA Assays 2 mL x 48 441122 Vaginal Specimen Transport for BD ProbeTec Q Amplified DNA Assays The TV preparations described previously are available from Gibson Laboratories LLC 1040 Manchester Street Lexington KY 40508 800 477 4763 www gibsonlabs com REFERENCES 1 o ka 10 11 12 Weinstock H S Berman and W Cates Jr 2004 Sexually transmitted diseases among American youth incidence and prevalence estimates 2000 Perspect Sex Reprod Health 36 1 6 10 Soper D 2004 Trichomoniasis under control or undercont
25. de Twenty four assay replicates were generated for each condition sample type temperature duration Pools of TV negative vaginal and endocervical swab specimen matrices in Q Swab Diluent were used in analytical experiments to support the storage stability claims for pre warmed expressed vaginal and endocervical swab specimens For both types of matrix pools were spiked with TV strain ATCC 30001 at 3x LOD 222 trichomonads mL for vaginal matrix and 195 trichomonads mL for endocervical matrix and aliquoted into 2 mL volumes in BD Viper specimen tubes The tubes were 16 pre warmed at 114 C for 15 min and cooled for 15 min After the pre warm process the specimen tubes were stored either at 2 8 C or 30 C for up to 30 days or at 20 C for up to 180 days At each time point samples were removed from storage and evaluated with the BD ProbeTec TV Q Assay on the BD Viper System in extracted mode Twenty four assay replicates were generated for each condition sample type temperature duration The expected results were obtained with the TV Q Assay under all conditions tested Reproducibility Reproducibility of the BD Viper System using the BD ProbeTec TV Q Assay was evaluated at three test sites two external and one internal site on one BD Viper System per site Panels were comprised of four levels of Trichomonas vaginalis seeded into urine specimen matrix or vaginal matrix in Q diluent Trichomonas vaginalis organism was spiked int
26. de Twenty four assay replicates were generated for each condition sample type temperature duration Endocervical Swab Specimen Stability Pools of TV negative endocervical swab matrix were used in analytical experiments to support the storage and transport stability claims for endocervical swab specimens Pools were spiked with TV strain ATCC 30001 to give 195 trichomonads mL 3x LOD The spiked swab matrix was stored at 2 8 C or 30 C for up to 30 days or at 20 C for up to 180 days At each time point samples were removed from storage and evaluated with the BD ProbeTec TV Q Assay on the BD Viper System in extracted mode Twenty four assay replicates were generated for each condition sample type temperature duration Post Pre Warm Specimen Stability Pools of TV negative neat urine matrix were used in analytical experiments to support the storage claims for pre warmed neat urine specimens Pools of neat urine were spiked with T vaginalis ATCC strain 30001 at 330 trichomonads mL 3 x LOD The neat urine pools were dispensed in 2 mL volumes into BD Viper specimen tubes The specimen tubes were pre warmed at 114 C for 15 min and cooled for 15 min After the pre warm process the specimen tubes were stored at 2 8 C for up to 7 days at 30 C for up to 3 days and at 20 C for up to 180 days At each time point samples were removed from storage and tested with the BD ProbeTec TV Q Assay on the BD Viper System in extracted mo
27. ectively The level tested was three times the determined limit of detection The strain with the lowest LOD for that sample type as determined by the LOD validations was used for these studies Results are summarized in Table 15 Table 15 TV Q Assay Potentially Interfering Substances Interpretation No interference observed Whole Blood 36096 Phenazopyridine Hydrochloride at levels listed Seminal Fluid Whole Blood 196 v v Mucus Acidic urine pH 5 0 Over the counter vaginal products and Alkaline urine pH 9 0 contraceptives Horomone pool Hemorrhoidal cream Analgesic pool Prescription vaginal treatments Antibiotics Leukocytes 1 x 10 cells mL Bilirubin Intravaginal hormones Mucus Albumin 1 mg mL Glucose Semen 5 v v Over the counter deodorant spray and powder Leukocytes 2 5x10 cells mL May cause extraction control Blood gt 60 Not applicable EC failures May cause false negative results Not applicable Not applicable Urine Specimen Stability Pools of T vaginalis negative female urine specimens were used in analytical experiments to support the urine storage and transport stability claims Neat urine pools were spiked with TV ATCC strain 30001 at 330 trichomonads mL 3x LOD in neat urine The pools were dispensed in 2 mL volumes into BD Viper Specimen Tubes and stored at the following conditions 2 8 C for up to 7 days 30 C for 18 and 24 hours 20 C for up to 180 days At each time point s
28. eipwonc aiguAevot e io Steriliz l s m dszere etil n oxid Metodo di sterilizzazione ossido di etilene Sterilizavimo b das etileno oksidas Steriliseringsmetode etylenoksid Metoda sterylizacji tlenek etylu M todo de esteriliza o xido de etileno Met da steriliz cie etyl noxid M todo de esterilizaci n xido de etileno Steriliseringsmetod etylenoxid Meroa Ha crepunuasauus erunenop okcua Metod de sterilizare oxid de etilen Sterilizasyon y ntemi etilen oksit Metoda sterilizacije etilen oksid Metog crepunusauw stuneHoKcug Crepunusauya agici ITUNEH TOTbIFbI Contains sufficient for n tests Dostatecn mno stv pro n test Indeholder tilstr kkeligt til n test Voldoende voor n tests K llaldane n testide jaoks Sis lt on riitt v n testej varten Contenu suffisant pour n tests Ausreichend f r n Tests l Iepi xei errapkr rroo rnra n ergoe n teszthez elegend Contenuto sufficiente per n test Pakankamas kiekis atlikti n testy Innholder tilstrekkelig for n tester Zawiera ilo wystarczaj c do n test w Cont mo suficiente para n testes Obsah vysta na n testov Contenido suficiente para n pruebas R ckertill n antal tester CegepxaHnvero e nocrareuHo 3a n recra Con ine suficient pentru n teste n testleri i in yeterli miktarda i erir Sadr aj dovoljan za n te
29. ells is shown in a color coded plate layout screen on the LCD Monitor The plus symbol within the microwell indicates the positive QC sample The minus symbol within the microwell indicates the negative QC sample A QC pair must be logged in for each plate to be tested and for each reagent kit lot number If a QC pair has not been logged in for each plate a message box appears that prevents saving the rack and proceeding with the run until a QC pair is added A maximum of two QC pairs per rack is permitted Other control materials may be added provided they are logged in as samples NOTE The BD Viper System will rehydrate the controls during the assay run Do not attempt to hydrate the controls prior to loading them into the BD Viper Lysing Rack Running one plate on a BD Viper System The first two positions A1 and B1 are reserved for the positive A1 and negative B1 controls respectively The first available position for a patient sample is C1 Running two plates on a BD Viper System For plate one the first two positions A1 and B1 are reserved for the positive A1 and negative B1 controls respectively The first available position for a patient sample is C1 For plate two the last two positions after the last patient sample are assigned as the positive and negative controls respectively The CT GC TV Q Positive Control and the CT GC TV Q Negative Control must test as positive and negative respectively If contr
30. eserved neat urine 5 Under or over dispensing of urine into Specimen Tubes may affect assay performance Assay Reagents 6 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Use only sample and control tubes with pierceable caps on the BD Viper System in Extracted Mode Do not remove pierceable caps prior to running the instrument Be sure to replace any punctured pierceable caps with new pierceable caps prior to running the instrument Do not interchange or mix kit reagents from kits with different lot numbers The BD Q Swab Diluent contains dimethyl sulfoxide DMSO which is harmful by inhalation in contact with skin and if swallowed Avoid contact with eyes In case of contact with eyes rinse immediately with plenty of water and seek medical advice After contact with skin wash immediately with plenty of water Only use the BD Viper pipette tips as supplied by BD with the BD Viper System The BD Viper Extraction Reagent and Lysis Troughs contain corrosive substances The use of personal protection equipment such as nitrile gloves safety glasses and lab coats is strongly recommended when handling these reagents Solutions have a strong caustic effect including severe burns on skin and mucous membranes Avoid contact with the eyes and skin Avoid breathing fumes vapors or spray Harmful if swallowed Do not eat or drink in the vicinity of these reagents In case of contact immediatel
31. g 8 Use of the BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay is limited to personnel who have been trained in the assay procedure and the BD Viper System 9 Trichomonas tenax was found to cross reactant with the TV Q Assay at levels above 1 0 x 10 organisms mL T tenax is a commensal of the oral cavity See TV Q Analytical Specificity for details 10 The performance of the BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay has not been evaluated in pregnant women or in patients less than 18 years of age 11 The performance of the BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay has not been evaluated in the presence of Dientamoeba fragilis CLINICAL PERFORMANCE EXPECTED RESULTS A Prevalence The prevalence of Trichomonas vaginalis observed in symptomatic and asymptomatic female subjects during a multi center trial April 2012 August 2012 was determined by the composite reference method result The prevalence for Trichomonas vaginalis for the neat urine specimens was 15 2 Prevalence was 13 5 and 13 8 respectively for the endocervical and vaginal swab specimens Table 6 summarizes the prevalence overall and by site Also provided are the number of positive results and total number of results by site from subjects designated by the composite reference as positive or negative Table 6 TV Q Assay Prevalence by Specimen Type and Collection Site Prevalence positive tested Nest uane
32. ge gloves before proceeding to avoid contamination Table 2 Urine Specimen Storage and Transport o mL OV Or Urine Specimen Type to be Processed Temperature Condition for Storage and Transport to Test Site Process and Test Specimen According Within 7 days of to Instructions collection collection Within 24 h of collections Within 180 days of Urine specimens that are refrigerated at 2 8 C after collection may be stored for up to 7 days prior to testing Urine specimens that are not refrigerated at 2 8 C after collection stored at temperatures up to 30 C must be tested within 24 hours QUALITY CONTROL PREPARATION NOTE Do not re hydrate the controls prior to loading in the BD Viper Lysing Rack 1 Using the tube layout report place CT GC TV Q Negative Controls into the appropriate positions in the BD Viper Lysing Rack 2 Using the tube layout report place CT GC TV Q Positive Controls into the appropriate positions in the BD Viper Lysing Rack 3 Controls and specimens are ready to be pre warmed PRE WARM PROCEDURE NOTE The pre warm procedure must be applied to all specimens to ensure that the specimen matrix is homogeneous prior to loading on the BD Viper System Failure to pre warm specimens may have an adverse impact on performance of the BD ProbeTec TV Q Amplified DNA Assay and or BD Viper System Pre warming of the controls is optional 1 Insert the BD Viper Lysing Rack into the BD Viper Lys
33. ginalis are among the most common conditions transmitted sexually It is estimated that in the United States 7 4 million new cases of trichomoniasis appear annually compared with 3 million cases of chlamydia and 718 000 cases of gonorrhea Despite being a readily diagnosed and treatable sexually transmitted disease trichomoniasis is not a reportable infection and control of the infection has received relatively little emphasis from public health STD control programs Trichomoniasis is caused by the parasitic protozoan Trichomonas vaginalis The infection causes some women to have symptoms which are characterized by a diffuse malodorous yellow green vaginal discharge with vulvar irritation The infection may cause discomfort during intercourse and urination as well as irritation and itching of the female genital area The genital inflammation caused by trichomoniasis can increase a woman s susceptibility to HIV infection if she is exposed to the virus Having trichomoniasis may increase the chance that an HIV infected woman passes HIV to her sex partner s Infected women may have minimal or no symptoms of the disease Because of this screening for T vaginalis in women can be considered in those at high risk for infection i e women who have new or multiple partners have a history of STDs exchange sex for payment and use injection drugs Today a commonly used test for a patient presenting with symptoms of vaginitis is the wet mount This is a
34. he BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay uses fluorescent energy transfer as the detection method to test for the presence of T vaginalis DNA in clinical specimens All calculations are performed automatically by the BD Viper software The presence or absence of T vaginalis DNA is determined by calculating the peak fluorescence MaxRFU over the course of the amplification process and by comparing this measurement to a predetermined threshold value The magnitude of the MaxRFU score is not indicative of the level of organism in the specimen If the T vaginalis specific signal is greater than or equal to a threshold of 125 MaxRFU the EC fluorescence is ignored by the algorithm If the T vaginalis specific signal is less than a threshold of 125 MaxRFU the EC fluorescence is utilized by the algorithm in the interpretation of the result If assay control results are not as expected patient results are not reported See the Quality Control section for expected control values Reported results are determined as follows Table 5 Interpretation of Test Results for the TV Q Assay Tube x z omm m Result 2125 T vaginalis DNA detected by Positive for T vaginalis DNA Positive Qe SDA T vaginalis organism viability and or infectivity cannot be inferred since target DNA may persist in the absence of viable organisms 125 T vaginalis DNA not detected Presumed negative for T vaginalis DNA Negative by SDA A negative result does
35. icles or organisms mL viruses and pathogens except where noted The TV Q Assay did not cross react with 53 of the 54 organisms tested with the assay at the above mentioned concentrations One organism T tenax was identified as a cross reactant at concentrations gt 1 x 10 organisms mL Table 14 Potentially Cross reacting Microorganisms oem H R rmm Fusobacterium nucleatum 3 00 x 10 CFU mL Staphylococcus aureus protein A producing 4 80 x 10 CFU mL Gardnerella vaginalis 4 07 x 10 CFU mL Staphylococcus epidermidis 1 80 x 10 CFU mL Haemophilus ducreyi 9 93 x 10 CFU mL Staphylococcus saprophyticus 3 47 x 10 CFU mL Herpes Simplex Virus Type 1 1 00 x 10 vp mL Streptococcus pyogenes Group A 3 73 x 10 CFU mL Herpes Simplex Virus Type 2 1 00 x 10 vp mL Streptococcus agalactiae Group B 5 67 x 10 CFU mL HPV 6 1 57 x 10 cells mL 1 50 x 10 Organisms mL HPV 11 4 87 x 10 cells mL Ureaplasma urealyticum 1 00 x 109 CFU mL HPV 16 8 43 x 10 cells mL Veillonella parvula 7 47 x 10 CFU mL 15 TV Q Interfering Substances The performance of the BD ProbeTec TV Or Assay on the BD Viper System in extracted mode was evaluated in the presence of potentially interfering substances which may be encountered in swab and urine specimens Potentially interfering substances were spiked into vaginal swab specimen or urine matrix in both the presence and the absence of T vaginalis ATCC strain 30001 or 50143 resp
36. ing Heater 2 Pre warm the samples for 15 min at 114 C 2 C 3 Remove the Lysing Rack from the Lysing Heater and let cool at room temperature for a minimum of 15 min before loading into the BD Viper instrument 4 Referto the Test Procedure for testing specimens and controls Table 3 Post Pre Warm Storage Conditions Temperature Condition for Storage after Pre Warm Specimen type Ee Vaginal Swabs Within 30 days Within 30 days Within 180 days in Q Swab Diluent after pre warm after pre warm after pre warm Within 30 days Within 30 days Within 180 days Endocervical Swabs after pre warm after pre warm after pre warm after pre warm Nas Ua aad Bho RC Within 7 days after Within 30 days pre warm after pre warm NOTE Frozen specimens must be brought to room temperature prior to pre warming or testing TEST PROCEDURE Refer to the BD Viper Instrument User s Manual Extracted Mode Operation for specific instructions for operating and maintaining the components of the system The optimum environmental conditions for the TV Q Assay were found to be 18 27 C and 20 85 Relative Humidity QUALITY CONTROL Quality control must be performed in accordance with applicable local state and or federal regulations or accreditation requirements and your laboratory s standard Quality Control procedures It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices The
37. kos prietaisas In vitro diagnostisk medisinsk utstyr Urzadzenie medyczne do diagnostyki in vitro Dispositivo m dico para diagn stico in vitro Medic nska pom cka na diagnostiku in vitro Dispositivo m dico de diagn stico in vitro Medicinsk anordning f r in vitro diagnostik MequuuHckn ypea 3a QuarHoctuka nH Burpo Aparatur medical de diagnosticare in vitro In Vitro Diyagnostik T bbi Cihaz Medicinski ure aj za in vitro dijagnostiku Mennuwuckwi npu6op Ans nuaruocruu in vitro 3Kacaune xar nanna xypriseria mMennuwHanelk AuarHocTuKa acna6bi Medicinska pomagala za In Vitro Dijagnostiku Batch Code Lot K d slo ar e Batch kode Lot Chargenummer lot Partii kood Er koodi LOT Code de lot Lot Chargencode Chargenbezeichnung Kw ik rrapr ag Naprida T tel sz ma Lot Codice del lotto partita Partijos numeris Lot Batch kode Serie Kod partii seria C digo do lote Lote K d s rie ar a C digo de lote Lote Satskod parti Kon Tlapruaa Num r lot Lotul Parti Kodu Lot Kod serije Kog naptuu nor Tontama Kopp Lot kod Method of sterilization ethylene oxide Zp sob sterilizace etylenoxid Sterilisationsm de Ethylenoxid Sterilisatiemethode ethyleenoxide Steriliseerimismeetod et leenoksiid Sterilointimenetelma etyleenioksidi M thode de st rilisation oxyde d thyl ne Sterilisationsmethode Ethylenoxid M 80d0 attooT
38. l from microwells at any time Priming Microwells with residual fluid after transfer of fluid from the Priming Microwells to the Amplification Microwells represent a potential source of target contamination Carefully seal Priming Microwells with plate sealer prior to disposal To prevent contamination of the work environment with amplification products use the disposal bags provided in the Accessory Kit to dispose of tested Amplification Microwells Make sure the bags are properly closed before disposal Although dedicated work areas are not required because the BD Viper design reduces the possibility of amplicon contamination in the testing environment other precautions for controlling contamination particularly to avoid contamination of specimens during manipulation are necessary CHANGE GLOVES if they come in contact with specimen or appear to be wet to avoid contaminating other specimens Change gloves before leaving work area and upon entry into work area In the event of contamination of the work area or equipment with samples or controls thoroughly clean the contaminated area with 396 w v hydrogen peroxide do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days 196 v v sodium hypochlorite or DNA AWAY and rinse thoroughly with water Allow surface to dry completely before proceeding In case of a spill on the BD Viper Lysing Rack immerse the rack in 196 v v sodium hypochlorite for 1 2 min Do
39. n easy to perform test that affords several results for the clinician to utilize in determining the cause of the vaginitis symptoms Another commonly used test is culture for Trichomonas vaginalis The sensitivity of the wet mount and TV culture under optimal conditions can range from 40 60969 when compared to PCR The wet mount result can be influenced by factors such as microscopist experience length of time from preparation until interpretation the ambient temperature and the collection devices used The wet mount result can only be interpreted as positive if the microscopist can visualize motile trichomonads Culture performance can be influenced by the time between inoculation and incubation as well as the temperature at which the culture is stored prior to and during incubation Trichomonads are extremely susceptible to cold temperatures and the culture can be adversely affected if allowed to become cold Controlled room temperature of 15 30 C should be maintained after inoculation of the culture but prior to incubation One or all of these factors can contribute to the poor sensitivity of the culture method The BD Viper System in Extracted Mode utilizes the newly developed BD ProbeTec Trichomonas vaginalis TV Or Amplified DNA Assay Automated extraction of DNA from clinical samples occurs on the BD Viper System through BD FOX extraction technology that incorporates chemical lysis followed by binding of DNA to magnetic particles washi
40. ng and elution The system is based on simultaneous amplification and detection of target DNA using amplification primers along with a fluorescently labeled detector probe PRINCIPLES OF THE PROCEDURE The BD ProbeTec TV Q Amplified DNA Assay is designed for use with the BD ProbeTec Q specimen collection and transport devices applicable reagents the BD Viper System and BD FOX Extraction Tubes Female urine specimens are collected and transported as a neat urine specimen All specimens undergo a pre warm step in the BD Viper Lysing Heater to dissolve mucus which may be present in certain specimens and to homogenize the specimen After cooling the specimens are loaded onto the BD Viper System which then performs all the steps involved in extraction and amplification of target DNA without further user intervention The specimen is transferred to an Extraction Tube that contains ferric oxide particles in a dissolvable film and dried Extraction Control A high pH is used to lyse the microorganisms and liberate their DNA into solution Acid is then added to lower the pH and induce a positive charge on the ferric oxide which in turn binds the negatively charged DNA The particles and bound DNA are then pulled to the sides of the Extraction Tube by magnets and the treated specimen is aspirated to waste The particles are washed and a high pH Elution Buffer is added to recover the purified DNA Finally a Neutralization Buffer is used to bring the pH of
41. not preclude T vaginalis infection because results are dependent on adequate specimen collection absence of inhibitors and the presence of sufficient DNA to be detected 125 Extraction Control Failure T vaginalis if present is not de Extraction Repeat test from initial Control specimen tube or obtain Failure another specimen for testing Any Extraction Transfer Failure T vaginalis if present is not de Extraction value Repeat test from initial Transfer specimen tube or obtain Failure another specimen for testi Any Liquid Level Failure T vaginalis if present is not detectable Liquid H value Repeat test from initial Level specimen tube or obtain Failure another specimen for testing Any Error Repeat test from initial T vaginalis if present is not detectable Error d Value specimen tube or obtain another specimen for testing 125 ROX Channel Failure T vaginalis if present is not detectable ROX Repeat test from initial Failure specimen tube or obtain another specimen for testing SPECIMEN PROCESSING CONTROLS Specimen Processing Controls may be tested in accordance with the requirements of appropriate accrediting organizations A positive Specimen Processing Control should test the entire assay system For this purpose known positive specimens can serve as controls by being processed and tested in conjunction with unknown specimens Specimens used as processing controls must be stored proce
42. o each specimen matrix at 1x and 3x LOD for the low positive and moderate positive panel members respectively Uninoculated urine and vaginal matrix in Q diluent were used as negative samples An additional target level was included in the panel to evaluate the reproducibility of test results i e proportion positive or negative at target levels below the analytical LOD of the BD ProbeTec TV Or Assay This additional panel member was created in each matrix using 0 3x the LOD This level was selected to fall within the dynamic range of the analytical LOD curves for the BD ProbeTec TV Q Assay Three replicates of each panel member were tested twice a day for five days on each BD Viper System in Extracted Mode A summary of the reproducibility data for each specimen matrix for the BD ProbeTec TV Q Assay is presented in Table 16 Table 16 Summary of Reproducibility Data for Vaginal and Urine Matrix when tested on the BD Viper System with the TV Q Assay Between Run Between Day n p D 6959 EE 3 89 HM 51 64 46 120 60 bd pus SC 795 66 814 68 102 39 36 11 190 15 23 90 Vaginal Low Positive 96 7 90 7 1X LOD 87 90 98 9 1632 07 457 83 28 05 10 13 s Positive 100 0 95 9 s LOD 90 90 100 0 1756 68 297 78 16 95 5 95 260 45 14 83 8 2 95 33 N o oO N mea Positive 92 1 84 6 M 82 89 96 1 1574 67 681 14 43 26 Pese eoo Goo Tas Four non reportable results were due to extraction
43. odukt wird unter einer Lizenz verkauft und der Erwerb berechtigt nicht dazu dieses Produkt f r bestimmte Screening Anwendungen zur Untersuchung von Blut und Gewebe oder f r bestimmte industrielle Anwendungen zu verwenden Questo prodotto venduto su licenza e il suo acquisto non include i diritti di utilizzo per determinate applicazioni di screening del sangue e dei tessuti n per alcune applicazioni industriali Este producto se vende bajo licencia y su compra no incluye derechos de uso para determinadas aplicaciones de detecci n sistem tica en sangre y tejidos ni para determinadas aplicaciones industriales ud Becton Dickinson and Company Benex Limited 7 Loveton Circle Pottery Road Dun Laoghaire Sparks MD 21152 USA Co Dublin Ireland 800 638 8663 www bd com ds DNA AWAY is a trademark of Molecular BioProducts Inc Tri Valent is a trademark of Gibson Laboratories BD BD Logo BD ProbeTec BD FOX and BD Viper are trademarks of Becton Dickinson and Company O 2013 BD 24
44. of Within 14 days Within 3days Within 180 days Specimen According to P S A A Instructions collection collection of collection of collection of collection Swab Specimen Processing Processing procedure for the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature and mixed by inversion prior to proceeding 1 Using a tube layout report place the Q Swab Diluent Tube with black pierceable cap in order in the BD Viper Lysing rack and lock into place 2 Repeat step 1 for additional swab specimens 3 Specimens are ready to be pre warmed 4 Change gloves before proceeding to avoid contamination Processing procedure for the Vaginal Specimen Transport for the BD ProbeTec TV Q Amplified DNA Assays NOTE Wear clean gloves when handling the vaginal swab specimen If gloves come in contact with specimen immediately change them to prevent contamination of other specimens NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature prior to expression 1 Labela pre filled Q Swab Diluent Tube for each vaginal swab specimen to be processed 2 Remove the cap and insert the swab specimen into the Q Swab Diluent Tube Mix by swirling the swab in the Q Swab Diluent Tube for 5 10 s Express the swab along the inside of the tube so that liquid runs back into the bottom of the tube Remove the swa
45. of organisms to create an LOD panel consisting of six target levels Data were generated for each target level n 60 per level and resulting MaxRFU values were analyzed to determine proportion positive at each level Proportion positive was used to generate positivity curves from which each 95 LOD was calculated The Limits of Detection LODs for the TV Q Assay with T vaginalis ATCC strains 30001 and 50143 in BD Q Swab Diluent when extracted on the BD Viper System were 54 5 and 55 5 trichomonads mL respectively The LODs for neat urine vaginal and endocervical specimen matrices are presented in Table 13 The TV Or Assay on the BD Viper system in extracted mode could detect with 2 95 proportion positive four additional ATCC strains 30237 50144 30184 and 30185 in urine matrix and three ATCC strains 30185 30237 and 50144 in vaginal swab specimen matrix at a concentration of 122 1 TV mL Table 13 LOD Estimates for TV Q Assay LOD Specimen type ATCC Strain TV mL 30001 109 7 Neat Urine 50143 108 2 z 30184 152 8 Endocervical LOD for T vaginalis ATCC strain 30184 was determined in vaginal swab specimen matrix only 14 TV Q Analytical Specificity DNA from 54 organisms listed in Table 14 was extracted on the BD Viper System and tested with the BD ProbeTec TV Q Amplified DNA Assay All potential cross reactive species were tested at approximately 2 1x109 CFU mL bacteria and yeast 2 1x10 vp mL viral part
46. ols do not perform as expected the run is considered invalid and results will not be reported by the instrument If either of the controls does not provide the expected results repeat the entire run using a new set of controls new extraction tubes new extraction trough new lysis trough and new microwells The Extraction Control EC oligonucleotide is labeled with a fluorescent dye and is used to confirm the validity of the extraction process The EC is dried in the Extraction Tubes and is rehydrated by the BD Viper System upon addition of the specimen and extraction reagents At the end of the extraction process the EC fluorescence is monitored by the instrument and an automated algorithm is applied to both the EC and TV Q Assay specific signals to report results as positive negative or EC failure Table 4 Interpretation of Quality Control Results x Qc Control Type Tube Result Report Symbol TV Q MaxRFU ontro CT GC TV Or Positive F CT GC TV Q Positive Contro Any value QC Failure ee Q Negative QC Pass ontrol ee Q Negative QC Failure Ontro E Q Negative Any value QC Failure Ontro CT GC TV Q Negative QC Failure Control ig Fail bf Extraction Transfer failure E Liquid Level failure b Extraction Control failure 0 Error ROX failure ROX Sulforhodamine dye used to monitor EC performance Consult the BD Viper Instrument User s Manual for additional information INTERPRETATION OF TEST RESULTS T
47. pecimens vaginal specimens and endocervical specimens Performance with other specimen types has not been assessed 2 Optimal performance of the test requires adequate specimen collection and handling Refer to the Specimen Collection Storage and Transport section of this insert 3 Anegative test does not exclude the possibility of infection because test results may be affected by improper specimen collection technical error specimen mix up concurrent antiprotozoal therapy or the quantity of organism in the specimen may be below the sensitivity of the test 4 As with many diagnostic tests results from the BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay should be interpreted in conjunction with other laboratory and clinical data available to the physician 5 The BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay provides qualitative results No correlation can be drawn between the magnitude of the positive assay signal MaxRFU and the quantity of nucleic acid in a patient sample 6 The Positive Control for the BD ProbeTec Trichomonas vaginalis TV Q Amplified DNA Assay is used in testing for TV therefore correct positioning of the microwell strips is important for final results reporting 7 The blank microwell is required to produce the EC results for the Negative Control and to verify extraction for negative specimens therefore correct positioning of the microwell strips is important for final results reportin
48. rolled Am J Obstet Gynecol 2 190 1 281 90 Schwebke J and Burgess D 2004 Trichomoniasis 2004 Clinical Micro reviews p 794 803 Centers for Disease Control and Prevention 2011 Trichomoniasis Fact Sheet Centers for Disease Control and Prevention 2010 Sexually Transmitted Diseases Treatment Guidelines MMWR 59 RR 12 Wendel KA Erbelding EJ Gaydos CA Rompalo AM 2002 Trichomonas vaginalis polymerase chain reaction compared with standard diagnostic and therapeutic protocols for detection and treatment of vaginal trichomoniasis Clin Infect Dis 35 5 576 80 Van Der Pol B et al 2001 Multicenter evaluation of the BD ProbeTec ET System for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens female endocervical swabs and male urethral swabs J Clin Microbiol 39 3 1008 16 Little M C et al 1999 Strand Displacement Amplification and Homogeneous Real Time Detection Incorporated in a Second Generation DNA Probes System BD ProbeTec ET Clin Chem 45 6 777 784 Clinical and Laboratory Standards Institute 2005 Approved Guideline M29 A3 Protection of Laboratory workers from occupactionally acquired infections 3rd ed CLSI Wayne PA Garner J S 1996 Hospital Infection Control Practices Advisory Committee U S Department of Health and Human Services Centers for Disease Control and Prevention Guideline for isolation precautions in hospitals Infect Control Hosp Epidemiol 17 53 80 U
49. se on the BD Viper System Extracted Mode Q Swab Diluent tubes BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens and Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays BD Viper Accessory Kit and Microwell Package for the BD Viper System Materials Required But Not Provided Nitrile gloves 3 w v hydrogen peroxide 1 v v sodium hypochlorite DNA AWAY displacement pipettes polypropylene aerosol resistant pipette tips capable of delivering 0 5 mL 0 05 mL and serological pipettes Do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days Prepare fresh daily Storage and Handling Requirements Reagents may be stored at 2 33 C Unopened Reagent Packs are stable until the expiration date Once a pouch is opened the microwells are stable for 6 weeks if properly sealed or until the expiration date whichever comes first Do not freeze WARNINGS AND PRECAUTIONS General 1 Forin vitro Diagnostic Use 2 Pathogenic microorganisms including hepatitis viruses and Human Immunodeficiency Virus may be present in clinical specimens Standard Precautions and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids 3 For additional specific warnings cautions and notes specific to the BD Viper consult the BD Viper Instrument User s Manual Specimen 4 Forfemale urine specimens use only unpr
50. sert the pink collection swab into the Q Swab Diluent Tube Break the shaft of the pink collection swab at the score mark Use care to avoid splashing of contents of the Q Swab Diluent Tube 10 Tightly recap the tube 11 Label the tube with patient information and date time collected 12 Transport to laboratory Vaginal Swab Patient Collection Procedure Vaginal swab specimens should be collected using the Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays NOTE Ensure that patients read the Patient Collection Instructions before providing them with a collection kit 1 Wash hands with soap and water Rinse and dry 2 Itis important to maintain a comfortable balance during the collection procedure 3 Twist the cap to break the seal Pull the cap with attached swab from the tube Do not touch the soft tip or lay the swab down If you touch or drop the swab tip or the swab is laid down discard the swab and request a new vaginal swab 4 Hold the swab by the cap with one hand so that the swab tip is pointing toward you 5 With your other hand gently spread the skin outside the vagina Insert the tip of the swab into the vaginal opening Point the tip toward your lower back and relax your muscles 6 Gently slide the swab no more than two inches into the vagina If the swab does not slide easily gently rotate the swab as you push If it is still difficult do not attempt to continue Make sure the swab touches the
51. ssed and tested according to the package insert instructions Specimen processing controls for T vaginalis may also be prepared in the laboratory using commercially available Gibson Laboratories Tri Valent Swab Positive Control Cat TVS 01 Gibson Laboratories Processing Control Preparation 1 Obtain Gibson Laboratories Tri Valent Swab Positive Control Cat TVS 01 from Gibson Laboratories 2 Store at 2 8 C per manufacturer s instructions 3 Remove control swab from container and express into a Q Swab Diluent Tube and tightly recap using a black pierceable cap 4 Process the controls according to the Pre warm Procedure and then follow the Test Procedure MONITORING FOR THE PRESENCE OF DNA CONTAMINATION At least monthly the following test procedure should be performed to monitor the work area and equipment surfaces for the presence of DNA contamination Environmental monitoring is essential to detect contamination prior to the development of a problem 1 For each area to be tested use a clean collection swab from the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens Dip the swab into the Q Swab Diluent Tube and wipe the first area using a broad sweeping motion Fully insert the collection swab into the Q Swab Diluent Tube Break the shaft of the swab at the score mark Use care to avoid splashing of contents Tightly recap the tube using the black pierceable cap Repeat for each desired area Af
52. stova 1ocrarouuo Ana n recroB a n recrrepi vun xerkinikri Sadr aj za n testova 20 1 ED A m GI Positive control Pozitivn kontrola Positiv kontrol Positieve controle Positiivne kontroll Positiivinkontrolli Contr le positif Positive Kontrolle Betik Aeyxoc Pozit v kontroll Controllo positivo Teigiama kontrol Positiv kontroll Kontrola dodatnia Controlo positivo Pozit vna kontrola Control positivo llonoxwreneH KoHTpon Etalon pozitiv Pozitif kontrol Pozitivna kontrola llonoxwrenbHblii kourpone XKaTbimgbi Gakbinay Temperature limitation Teplotn omezen Temperaturbegreensning Temperatuurlimiet Temperatuuri piirang L mp tilarajoitus Temp rature limite Zul ssiger Temperaturenbereich Opio BepyoKpaciac H m rs kleti hat r Temperatura limite Laikymo temperat ra Temperaturbegrensning Ograniczenie temperatury Limita o da temperatura Ohrani enie teploty Limitaci n de temperatura Temperaturbegr nsning TemnepatypHu orpaHuyeuya Limitare de temperatura Sicaklik s n rlamas Ograni enje temperature Orpannyenne Temnepartypb Tewneparypauei wektey Dozvoljena temperatura Consult Instructions for Use Prostudujte pokyny k pou it L s brugsanvisningen Raadpleeg gebruiksaanwijzing Lugeda kasutusjuhendit Tarkista k ytt ohjeista Consulter la notice d emploi Gebrauchsanweisung beachten ZupBouaeuteite ric oony
53. ter all swabs have been collected process according to the Pre warming Procedure and then follow the Test Procedure OUST E oq Recommended areas to test include Instrument deck Pipette Tip Station Covers 2 Tube Processing Station Tube Alignment Block and Fixed Metal Base Deck Waste Area Priming and Warming Heaters Stage Extraction Block Plate Sealing Tool Tip Exchange Stations 2 Instrument Exterior Upper Door Handle Lower Door Handle Waste Liquid Quick Release Valve LCD Monitor Touchscreen Keyboard Scanner Staging Area Locking Plate and Fixed Metal Base Accessories Tube Lockdown cover BD Viper Lysing Rack Table Base BD Viper Lysing Heater Metal Microwell Plates Timer Laboratory Bench Surfaces If an area gives a positive result or if contamination is suspected clean the area with fresh 196 v v sodium hypochlorite DNA AWAY or 3 w v hydrogen peroxide Make sure the entire area is wetted with the solution and allowed to remain on the surface for at least two minutes or until dry If necessary remove excess cleaning solution with a clean towel Wipe the area with a clean towel saturated with water and allow the surface to dry Retest the area Repeat cleaning process until negative results are obtained If the contamination does not resolve contact BD Technical Services for additional information LIMITATIONS OF THE PROCEDURE 1 This method has been tested only with female symptomatic and asymptomatic neat urine s
54. th stabilizers and buffer components NOTE Each microwell pouch contains one desiccant bag Additional Reagents Control Set for the BD ProbeTec Chlamydia trachomatis CT Neisseria gonorrhoeae GC and Trichomonas vaginalis TV Q Amplified DNA Assays 24 CT GC TV Q Positive Control Tubes containing approximately 2400 copies of pCTB4 and pGCINT3 and approximately 4000 copies of TVAP651 linearized plasmids in carrier nucleic acid and 24 CT GC TV Q Negative Control Tubes containing carrier nucleic acid alone The concentration of the CTB4 GCINT3 and TVAP651 plasmids are determined by UV spectrophotometry BD FOX Extraction Tubes 48 strips of 8 tubes each containing approximately 10 mg of iron oxide in a dissolvable film and approximately 240 pmol fluorescently labeled Extraction Control oligonucleotide BD Viper Extraction Reagent and Lysis Trough 12 Reagent and 12 Lysis troughs each 4 cavity Extraction Reagent Trough contains approximately 16 5 mL Binding Acid 117 mL Wash Buffer 35 mL Elution Buffer and 29 mL Neutralization Buffer with preservative each Lysis Trough contains approximately 11 5 mL Lysis Reagent INSTRUMENT EQUIPMENT AND SUPPLIES Materials Provided BD Viper Instrument Instrument Plates BD Viper Pipette Tips BD Viper Tip Waste Boxes BD Viper Amplification Plate Sealers Black and Seal Tool BD Viper Lysing Heater BD Viper Lysing Rack BD Viper Neutralization Pouches Specimen Tubes and Pierceable Caps for u
55. tomatic and asymptomatic female subjects attending family planning OB GYN and sexually transmitted disease clinics at 7 geographically diverse clinical sites in North America Subjects were classified as symptomatic if they presented to the clinic with abnormal vaginal discharge itching dysuria or odor as determined by the inclusion exclusion criteria The final data analysis included 1197 evaluable subjects Exclusions from the data analysis were made due to specimens not collected enrollment issues transport errors collection errors shipping errors processing errors or BD Viper System operating errors The final data analysis included 735 compliant results for the neat urine specimen type 838 compliant results for the vaginal swab specimen type and 995 compliant results for the endocervical swab specimen type For each subject a first void urine was collected in a sterile urine cup The urine was aliquoted into BD Viper Specimen Tubes Subsequent to the urine being collected the subject self collected a BD ProbeTec Vaginal Swab for testing on the BD ProbeTec TV Or Assay This was followed by two clinician collected vaginal swabs obtained for composite reference testing of the wet mount and TV culture for detection of Trichomonas vaginalis and one clinician collected vaginal swab for discrepant testing Lastly the clinician collected an endocervical swab for testing on the BD ProbeTec TV Q Assay The wet mount was performed at the bedside and the
56. walls of the vagina so that moisture is absorbed by the swab 7 Rotate the swab for 10 15 s 8 Withdraw the swab without touching the skin Place the swab in the tube and cap securely 9 After collection wash hands with soap and water rinse and dry 10 Return tube with swab as instructed Table 1 provides instructions for storage and transport conditions to the laboratory and or test site for swab specimens The endocervical swab specimens must be stored and transported to the laboratory and or test site within 30 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens must be stored and transported to the laboratory and or test site within 14 days after collection if kept at 2 8 C within 3 days if kept at 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens that are expressed in Q Swab Diluent may be stored and processed within 30 days after expression if kept at 2 30 C or within 180 days after the date of expression if kept frozen at 20 C Table 1 Swab Specimen Storage and Transport Endocervical Swab Specimens Swab Specimen and Type to be Processed Expressed Vaginal Swab Specimens Dry Vaginal Swab Specimens Temperature Condition for Storage and 2 30 C 20 C 2 8 C 30 C 20 C Transport to Test Site Process and Test Within 30 days of Within 180 days
57. y remove contaminated clothing wash the skin with water and soap and rinse thoroughly In case of contact with eyes rinse immediately with plenty of water and seek medical advice Use only the BD Viper Amplification Plate Sealers Black on the Amplification plates with the BD Viper System Using the clear sealers for sealing the Amplification plates may cause erroneous results Reagent pouches containing unused Priming Microwells and Amplification Microwells MUST be carefully resealed after opening Verify that desiccant is present prior to resealing the reagent pouches Because the blank microwell is required to produce the EC results for the Negative Control and to verify extraction for negative specimens in the TV Q Assay when run as a stand alone assay correct positioning of the microwell strips is important for final results reporting The Microwell Package for the BD Viper System contains blank microwells that are packaged in a zip lock bag To ensure that these do not become contaminated or acquire debris microwells MUST remain in the sealed zip lock bag until they are to be used The plate containing the Amplification Microwells MUST be properly sealed with the black Amplification Plate Sealer prior to removing the plate from the BD Viper System Sealing ensures a closed reaction for amplification and detection and is necessary to avoid contamination of the instrument and work area with amplification products Do not remove sealing materia
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