Package Insert
Contents
1. MM slutet pa m naden TITTF MM U FTTT MM MM kpas Ha meceua AAAA LL ZZ AAAA LL LL sf r itul lunii YYYY AA GG YYYY AA AA 7 ayin sonu GGGG MM DD GGGG MM MM kraj meseca TTTF MM AJ FTTT MM MM koneu mecaya MOIOIOICAA KK 4OIOIOICAA AA alinBIH COHb GGGG MM DD GGGG MM MM kraj mjeseca Catalog number Katalogov slo Katalognummer Catalogusnummer Kataloogi number Tuotenumero Num ro catalogue Bestellnummer Api amp u c karaA you Katal gussz m Numero di catalogo Katalogo numeris Numer katalogowy Numero do cat logo Katal gov slo Numero de cat logo KaranoxeH Homep Num r de catalog Katalog numaras Katalo ki broj Homep no karanory Karanor Hemipi Authorized Representative in the European Community Autorizovany z stupce pro Evropskou unii Autoriseret repraesentant i EU 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 ouciodotnp vocg avrimp currog orrv Eupurraikri Koiv rnra Hivatalos k pviselet az Eur pai Uni ban Rappresentante autorizzato nella Comunit europea Jgaliotasis atstovas Europos Bendrijoje Autorisert representant i EU Autoryzowane przedstawicielstwo w Unii Europejskiej Representante autorizado na Unido Europeia Autorizovany z stupca v Eur pskom spolo ens2. approximately 2 5 mL to 3 45 mL 25 UPT performance has not been established on BD Viper instruments that do not have onboard readers Cat 440740 EXPECTED RESULTS Refer to the BD Viper Instrument User s Manual Addendum and the BD ProbeTec ET CT GC Amplified DNA Assay package insert for expected results PERFORMANCE CHARACTERISTICS Refer to the BD Viper Instrument User s Manual Addendum and the BD ProbeTec ET CT GC Amplified DNA Assay package insert for performance characteristics AVAILABILITY The following BD ProbeTec ET products are also available Cat No Description 220142 BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Collection Kit for Endocervical Specimens 100 units 220143 BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Collection Kit for Male Urethral Specimens 100 units 440451 BD ProbeTec ET CT GC Control Set 20 positive and 20 negative 440452 BD ProbeTec ET CT GC Diluent Tubes 2 mL x 400 440453 BD ProbeTec ET Diluent CT GC 4 x 225 mL 440455 BD ProbeTec ET Sample Tubes and Caps 4 x 100 440456 BD ProbeTec ET Caps 4 x 100 440461 BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit 1 x 100 440476 BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Endocervical Specimen
3. Unpreserved Neat Urine 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 15 60 mL of voided urine the first part of the stream not midstream into a urine collection cup 4 Capand label the urine collection cup with patient identification and date time collected Storage and Transport 1 Store and transport neat urine from the collection site to the test site at 2 30 C 2 Sample processing must be completed within 30 h of collection if stored at 2 30 C or within 7 days of collection if stored at 2 8 C NOTE Specimens must be shipped in an insulated container with ice using either an overnight or 2 day delivery vendor Storage up to 7 days at 2 8 C has been demonstrated with seeded specimens Using BD ProbeTec Urine Preservative Transport Kit UPT 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 15 60 mL of voided urine the first part of the stream not midstream into a urine collection cup 4 Cap and label the urine collection cup with patient identification and date time collected Urine Transfer to UPT NOTES Urine should be transferred from collection c
4. ev Ker ysp iv Date de pr l vement Entnahmedatum Huepopnvia ouAMoyric Mintav tel ideje Data prelievo Paemimo data Dato provetaking Data pobrania Data da colheita D tum odberu Fecha de coleccion Uppsamlingsdatum Hara Ha cb npare Data colect rii Toplama tarihi Datum prikupljanja Qara cOopa Kunaran Tis6exyHi Dani sakupljanja Peel Otev ete zde Abnes her Afpellen Koorida Veda D coller Abziehen X uBoAo amok AAnong H zza le Strappare per aprire Pl sti ia Trekke av Oderwac Destac vel Odtrhnite Desprender Drag is r OGenere Se dezlipeste Ay rma Oljustiti OTknevtb ctinri Katar ann racra Otvoriti skini Contains sufficient for n tests Dostatetn 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 Nepi xet errapkrj rroo rmra lt n gt e er osic 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 CbabpkaHveTo e HocrareuHo 3a n Tecra Con ine suficient pentr
5. gonorrhoeae only has not been determined 21 Performance characteristics for detecting N gonorrhoeae in males are based on testing patients with infection rates of 0 43 the male populations sampled were primarily from STD clinics where the prevalence of GC is higher than in other clinical settings In males 16 gonococcal infections were identified in the low prevalence setting 0 8 prevalence Likewise the majority of females in the study with GC infections were from STD clinics In females only six gonococcal infections were identified in the low prevalence setting 1 296 prevalence Positive results in low prevalence populations should be interpreted carefully in conjunction with clinical signs and symptoms patient risk profile and other findings with the understanding that the likelihood of a false positive may be higher than a true positive 22 Testing urine specimens from female patients as the sole test for identifying gonococcal infections may miss infected individuals 11 80 or 13 896 of females with GC positive cultures had negative results when urine only was tested with the BD ProbeTec ET GC Assay 23 Because the AC uses GC target the efficacy of the AC for detecting inhibition is reduced in GC infected samples Refer to Performance Characteristics for results with co infected patients 24 Performance has not been established for UPT fill volumes other than volumes falling within the black lines on the fill window
6. limited to personnel who have been trained in the assay procedure and the BD ProbeTec ET system 15 In laboratory studies blood gt 5 v v was shown to cause indeterminate inhibitory results in both urine and swab specimens with AC and false negative results in urine specimens with and without AC Blood gt 5 v v may cause false negative results in swab specimens with and without AC Specimens with moderate to gross blood may interfere with BD ProbeTec ET GC Assay results Refer to Performance Characteristics for specific performance of female swab specimens with observed blood 16 The presence of highly pigmented substances in urine such as bilirubin 10 mg mL and Phenazopyridine 10 mg mL may cause indeterminate or false negative results 17 Leukocytes in excess of 250 000 cells mL swab specimens may cause indeterminate or false negative results 18 The presence of serum feminine deodorant sprays or talcum powder may cause false negative results urine specimens 19 The BD ProbeTec ET N gonorrhoeae Amplified DNA Assays may cross react with N cinerea and N lactamica Refer to Performance Characteristics for further information 20 The reproducibility of the BD ProbeTec ET GC Assay was established using seeded swab specimens and seeded buffer to simulate urine specimens These specimens were inoculated with both C trachomatis and N gonorrhoeae Reproducibility when testing urine samples and samples with N
7. stored at 20 C for up to two months TEST PROCEDURE The optimum environmental conditions for the GC assay were found to be 18 23 C at 25 75 Relative Humidity and 23 28 C at 25 50 Relative Humidity The performance of the GC assay at temperatures in excess of 28 C is not recommended Refer to the BD Viper Instrument User s Manual for specific instructions for operating and maintaining the instrument Testing Procedure for the GC AC Reagent Pack Refer to the BD Viper Instrument User s Manual Addendum for the test procedure QUALITY CONTROL The BD ProbeTec ET Ch amydia trachomatis Neisseria gonorrhoeae positive and negative control set 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 may be randomly positioned The CT GC positive control will monitor for substantial reagent failure only The CT GC negative control monitors for reagent and or environmental contamination The positive control has both cloned CT and GC target regions that are not necessarily representative of organism target DNA detected by the assay nor do they represent specimen matrices urine and epithelial cell suspensions indicated for use with the BD ProbeTec ET System These controls may be used for internal quality control or users may develop their own internal quality control material as described by CLSI C24 A3 19 Additional controls may be tested according
8. to detect the presence of Neisseria gonorrhoeae in endocervical swabs male urethral swabs and male and female urine specimens using the appropriate collection method The only devices that have been validated for collecting swab specimens for testing on the BD Viper System are BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit e BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Collection Kit for Endocervical Specimens e BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified Assay Collection Kit for Male Urethral Specimens For U S and international shipments specimens should be labeled in compliance with applicable state federal and international regulations covering the transport of clinical specimens and etiologic agents infectious substances Time and temperature conditions for storage must be maintained during transport Urine specimens must be collected in a sterile plastic preservative free specimen collection cup For urine specimens the BD ProbeTec Urine Preservative Transport UPT and unpreserved neat urine have been validated Swab Specimen Collection Endocervical Swab Specimen Collection using BD ProbeTec ET CT GC Amplified D
9. 21000 N gonorrhoeae not Presumed negative for N gonorrhoeae A negative Negative detected by SDA result does not preclude N gonorrhoeae infection because results are dependent on adequate specimen collection absence of inhibitors and sufficient DNA to be detected 2000 1000 Amplification control Repeatedly inhibitory specimen N gonorrhoeae Indeterminate inhibited Repeat test if present would not be detectable using SDA Submit another specimen for testing 1 According to CDC guidelines consideration should be given to routine additional testing for persons with positive N gonorrhoeae screening tests when risk factor information or actual surveys indicate that the prevalence is low 6 resulting in a lower PPV e g lt 90 Regardless of the screening method used e g NAAT DFA EIA Nucleic Acid Probe all positive screening tests should be considered presumptive evidence of infection 11 Refer to CDC guidelines for details on additional testing and patient management after a positive screening test 2 Refer to cutoff description and Figures 2 and 3 in Performance Characteristics of the BD ProbeTec ET CT GC Amplified DNA Assay package insert for additional information on the distribution of GC MOTA values by specimen type observed in the clinical trials 3 The magnitude of the MOTA score is not indicative of the level of organism in the specimen Repeat BD Viper test For urines repeat from the original spec
10. Collection and DRY TRANSPORT Kit 100 each 440474 BD ProbeTec ET CT AC Reagent Pack 384 tests 440928 BD ProbeTec Urine Preservative Transport Kit 100 box The following strain is available from American Type Culture Collection ATCC 10801 University Boulevard Manassas VA 20110 2209 USA ATCC Strain 19424 Neisseria gonorrhoeae REFERENCES 1 10 11 Knapp J S Koumans E H 1999 Neisseria and Branhamella p 586 603 In Murray P R Baron M J Pfaller M A Tenover F C and Yolken R H ed Manual of Clinical Microbiology 7th ed American Society for Microbiology Washington D C Koneman E W Allen S D Janda W M Schreckenberger P C Winn W C Jr 1997 Neisseria Species and Moraxella catarrhalis p 491 537 In Color Atlas and Textbook of Diagnostic Microbiology 5th ed Lippincott Raven Publishers Philadelphia Walker G T Frasier M S Schram J L Little M C Nadeau J G Malinowski D P 1992 Strand Displacement Amplification an Isothermal in vitro DNA Amplification Technique Nucleic Acids Res 20 7 1691 1696 Little M C et al 1999 Strand Displacement Amplification and Homogeneous Real Time Detection Incorporated in a Second Generation DNA Probe System BD ProbeTec ET Clin Chem 45 6 777 784 Spargo C A Frasier M S Van Cleve M Wright D J Nycz C M Spears P A Walker G T 1996 Detection of M tuberculos
11. NA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit 1 Remove excess mucus from the cervical os with the large tipped cleaning swab provided in the BD ProbeTec ET CT GC Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit and discard Insert the Endocervical Specimen Collection and DRY TRANSPORT swab into the cervical canal and rotate for 15 30 s Withdraw the swab carefully Avoid contact with the vaginal mucosa Immediately place the cap swab into the transport tube Make sure the cap is tightly secured to the tube Label the tube with patient information and date time collected Transport to laboratory Endocervical Swab Specimen Collection using BD ProbeTec ET CT GC Amplified DNA Assay Collection Kit for Endocervical Specimens 1 Remove the cleaning swab from packaging Using cleaning swab remove excess mucus from the cervical os Discard the used cleaning swab Remove the collection swab from packaging Insert the collection swab into the cervical canal and rotate for 15 30 s Withdraw the swab carefully Avoid contact with the vaginal mucosa Uncap the CT GC diluent tube Fully insert the collection swab into the CT GC Diluent tube 9 Break the shaft of the swab at the score mark Use care to avoid splashing of contents 10 Tightly recap the tube 11 Label the tube with patient information and date time collected 12 Transport to laboratory Y OUI NS Q0 ten Oy SO ji UI NJ M
12. Revisions SO 0191 5 Rev from Rev to ECO 0908 2010 07 5132 09 Notes 1 BD Cat Number 441123 2 Blank Sheet Size Length 8 5 Width 11 Number of Pages 12 Number of Sheets 3 Page Size Length 8 5 Width 5 5 Final Folded Size 8 5 x 5 5 Style see illustrations below 5 ges el mmm pes E HEADER HEADER d DER 3 4 HEADER a 5 6 7 See Specification Control Number BALT 8080185 for Material Information Ink Colors Printed two sides x Yes No No of Colors 1 PMS Standard Black Graphics are approved by Becton Dickinson and Company Supplier has the responsibility for using the most current approved revision level Label Design COMPANY CONFIDENTAL THIS DOCUMENT IS Mm BD Becton Dickinson and Company THE PROPERTY OF BECTON DICKINSON AND RI 7 Lovetoni Circle Proofer COMPANY AND IS NOT TO BE USED OUTSIDE THE COMPANY WITHOUT WRITTEN PERMISSION Sparks MD 21152 USA Category and Description Sheet 1 of 13 Part Number Package Insert A 8080185 BD ProbeTec ET GC AC Amplified DNA Assay scale N A Checked By amp BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay C 8080185 2010 07 Pokyny vam poskytne m stn z stupce spole nosti BD Kontakt den lokale BD repr sentant for at fa instruktioner Kasutusjuhiste suhtes kontakteeruge oma kohaliku BD esindajaga Um Anleitungen zu erhalten wenden Sie sich bitte an Ihren BD Kundend
13. able for 4 weeks if properly sealed or until the expiration date whichever comes first Do not freeze Warnings and Precautions For in vitro Diagnostic Use 1 Wear personal protective equipment including eye protection when handling biological specimens 2 This reagent pack is for testing endocervical and male urethral swabs and male and female urine specimens with the BD Viper System 3 For collection of endocervical swab specimens only the BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit and the BD ProbeTec ET CT GC Amplified DNA Assay Collection Kit for Endocervical Specimens have been validated 4 For collection of male urethral swab specimens only the BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit and the BD ProbeTec ET CT GC Amplified Assay Collection Kit for Male Urethral Specimens have been validated 5 For urine specimens the BD ProbeTec Urine Preservative Transport UPT and unpreserved neat urine have been validated 6 The BD ProbeTec Urine Preservative Transport UPT Kit contains NAP Guard gt 742 5 mM K EDTA NAP Guard may be irritating to the eyes skin and respiratory system In case of contact with eyes rinse opened eye immediately with plenty of water and seek medical advice if symptoms persist After contact with skin was
14. ale Urethral Swab Specimen Collection using BD ProbeTec ET CT GC Amplified DNA Assay Male Urethral Collection and DRY TRANSPORT Kit 1 Insert the Male Urethral Collection and DRY TRANSPORT swab 2 4 cm into the urethra and rotate for 3 5 s 2 Withdraw the swab and place the cap swab into the transport tube Make sure the cap is tightly secured to the tube 3 Label the tube with patient information and date time collected 4 Transport to laboratory Male Urethral Swab Specimen Collection using BD ProbeTec ET CT GC Amplified Assay Collection Kit for Male Urethral Specimens 1 Remove the swab from packaging Insert the swab 2 4 cm into the urethra and rotate for 3 5 s Withdraw the swab Uncap the CT GC Diluent tube Fully insert the swab into the CT GC Diluent tube Break the shaft of the swab at the score mark Use care to avoid splashing of contents Tightly recap the tube Label the tube with patient information and date time collected Transport to laboratory 107 099 CON CU C Ud UND Swab Storage and Transport After collection the endocervical swabs and the male urethral swabs must be stored and transported to the laboratory and or test site at 2 27 C within 4 6 days Storage up to 4 days has been validated with clinical specimens storage up to 6 days has been demonstrated with seeded specimens In addition storage up to 30 days at 2 8 C has been demonstrated with seeded specimens Refer to Performan
15. ay be tested in accordance with the requirements of appropriate accrediting organizations A positive 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 processed and tested according to the package insert As an alternative to using positive specimens specimen processing controls simulating urine processing can be prepared as described below Neisseria gonorrhoeae If a known positive specimen is not available another approach is to assay a stock culture of N gonorrhoeae available from the ATCC strain 19424 prepared as described below 1 Thaw a vial of N gonorrhoeae stock culture received from ATCC and immediately inoculate a chocolate agar plate Incubate at 37 C in 3 5 CO for 24 48 h Resuspend colonies from the chocolate agar plate with phosphate buffered saline PBS Dilute cells in PBS to a 1 0 McFarland turbidity standard approximately 3 X 108 cells mL Prepare 10 fold serial dilutions to a 105 dilution of the McFarland at least 5 mL final volume in PBS Place 4 mL of the 105 dilution in a BD ProbeTec ET sample tube Process as a urine sample starting at Section C step 5 of the Test Procedure After processing lyse sample as described in Section E of the Test Procedure Continue testing as described in Section F of the Test Proced
16. below the sensitivity of the test 8 As with many diagnostic tests results from the BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay should be interpreted in conjunction with other laboratory and clinical data available to the physician 9 The BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay should not be used for the evaluation of suspected sexual abuse or for other medico legal indications Additional testing is recommended in any circumstance when false positive or false negative results could lead to adverse medical social or psychological consequences 10 The BD ProbeTec ET system cannot be used to assess therapeutic success or failure since nucleic acids from Neisseria gonorrhoeae may persist following antimicrobial therapy 11 The BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay provides qualitative results No correlation can be drawn between the magnitude of MOTA score and the number of cells in an infected sample 12 The predictive value of an assay depends on the prevalence of the disease in any particular population Refer to the BD ProbeTec ET CT GC Amplified DNA Assay package insert for hypothetical predictive values when testing varied populations 13 Correct positioning of the microwell strips is important for final results reporting Refer to the BD Viper Instrument User s Manual Addendum for correct microwell strip positioning 14 Use of the BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay is
17. ce Characteristics NOTE If specimens cannot be transported directly to the testing laboratory under ambient temperatures 15 27 C and must be shipped an insulated container with ice should be used with either an overnight or 2 day delivery vendor Specimen Type to be Female Endocervical Male Urethral Processed Temperature Condition for Transport to Test 2 27C 2 8 C 2 27 C 2 8 C Site and Storage Process Specimen Within 4 6 days of Within 30 days of Within 4 6 days of Within 30 days of According to f 2 r 19 collection collection collection collection Instructions Urine Specimen Collection Storage and Transport Collect urine specimen in a sterile preservative free collection cup Urine specimens may be stored and transported in two ways 1 unpreserved neat and 2 using the BD ProbeTec Urine Preservative Transport UPT The following chart provides a summary of storage and transport conditions for neat urine and UPT Urine Specimen Type to be Processed Urine Stored at 2 30 C Transfer to UPT Within 8 Hours of Collection Urine Stored at 2 8 C Transfer to UPT Within 24 Hours of Collection Temperature Condition for Transport to Test Site and Storage Process ithi Within within Within Within Within Specimen 7 30 days after 30 days after 2 months According to days of monde of transfer to transfer to after transfer Instructions collection collection collection UPT UPT to UPT
18. e Reagent Pack lot number controls must be tested with each lot Remove the cap from the CT GC Negative Control Tube Using a new pipette tip or pipette add 2 0 mL of Diluent Recap the tube and vortex for 5 s Remove the cap from the CT GC Positive Control Tube Using a new pipette tip or pipette add 2 0 mL of Diluent Recap the tube and vortex for 5 s Controls are ready to be lysed Si w BOUM Once the controls have been prepared continue with testing as described in the BD Viper Instrument User s Manual Addendum When the GC AC Reagent Pack is used the AC must be included for each patient sample and control The Amplification Control microwells contain 2 1000 copies per reaction of pGC10 linearized plasmid that should be amplified in the sample matrix The amplification control is designed to identify samples that may contain amplification inhibitors that could prevent detection of GC DNA if present See Interpretation of Results Intepretation of Control Results Control Interpretation without the AC GC MOTA Score Result CT GC Positive Control MOTA 2 2000 Acceptable CT GC Negative Control MOTA 2000 Acceptable Control Interpretation with the AC GC MOTA Score AC MOTA Score Result CT GC Positive Control MOTA 2 2000 MOTA 2 1000 Acceptable CT GC Negative Control MOTA 2000 MOTA 2 1000 Acceptable f the AC fails MOTA 1000 the control fails Specimen Processing Controls Specimen processing controls m
19. formula True Positive True Positive False Positive The data are not adjusted for prevalence GC results between 2 000 10 000 MOTA had a PPV ranging from 44 75 compared to a PPV range of 90 100 for MOTA values above 10 000 Depending on the types of specimens tested populations sampled and laboratory practices supplemental testing for specimens with MOTA values between 2 000 10 000 may be useful Refer to CDC guidelines for details on additional testing and patient management after a positive screening test N cinerea has been shown to cross react in the BD ProbeTec ET GC assay and other Neisseria species may also cause false positive results In settings with a high prevalence of sexually transmitted disease positive assay results have a high likelihood of being truly positive In settings with a low prevalence of sexually transmitted disease or in any setting in which a patient s clinical signs and symptoms or risk factors are inconsistent with gonococcal urogenital infection positive results should be carefully assessed and the patient retested by other methods e g culture for GC if appropriate LIMITATIONS OF THE PROCEDURE 1 This method has been tested only with endocervical swabs male urethral swabs and male and female urine 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 Sample Collectio
20. h immediately with plenty of soap and water If inhaled seek medical attention in case of problems 7 Laboratories may validate other swab or urine collection and transport devices for use with the BD ProbeTec ET GC assay according to the Verification and Validation Procedures in the Clinical Microbiology Laboratory Cumitech 31 B L Elder et al American Society for Microbiology Washington D C February 1997 8 Do not test the CT GC Diluent tube from the BD ProbeTec ET CT GC Amplified Assay Collection Kits if received in the laboratory without the swab present A false negative test result may occur 9 Do not interchange or mix kit reagents from kits with different lot numbers 10 Pathogenic microorganisms including hepatitis viruses and Human Immunodeficiency Virus may be present in clinical specimens Standard Precautions 6 9 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids 11 Use established laboratory practices when disposing of used pipette tips sample tubes Priming Microwells and other disposables Discard disposables carefully Seal and dispose of waste containers when they are 3 4 full or daily whichever comes first 12 The BD ProbeTec ET Diluent CT GC and CT GC Diluent tube contain dimethyl sulfoxide DMSO DMSO is harmful by inhalation contact with skin or if swallowed Avoid contact with eyes In case of contact with eyes rinse immediately w
21. hosphate DMSO glycerol Polysorbate 20 and 0 03 Proclin preservative The concentration of this DNA was determined spectrophotometrically at 260 nm Instrument equipment and supplies BD Viper BD Viper Lysing Heater BD Viper Lysing Rack and base BD ProbeTec Urine Preservative Transport Kit BD ProbeTec ET Sample Tubes and Caps BD Viper pipette tips tip waste boxes and bags Amplification Black plate sealers BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit or BD ProbeTec ET CT GC Amplified DNA Assay Collection Kit for Endocervical Specimens BD ProbeTec ET Chlamydia trachomatis Neisseria gonorrhoeae CT GC Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit or BD ProbeTec ET CT GC Amplified DNA Assay Collection Kit for Male Urethral Specimens Materials Required But Not Provided Centrifuge capable of 2000 x g vortex mixer gloves pipettes capable of delivering 1 mL 2 mL and 4 mL DNA AWAY or 1 v v sodium hypochlorite clean container suitable for holding aliquotted Diluent timer and absorbent paper sterile urine specimen collection cups Empty microwells and alcohol wipes 70 Isopropanol Mix 200 mL of bleach with 800 mL of water 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 st
22. ienst ErriKoivcovrjors pe Tov TOTTIKO avrimp ourro THs BD yia odnyies A haszn lati utas t st k rje a BD helyi k pviselet t l Contattare il rappresentante BD di zona per ottenere il foglietto illustrativo Naudojimo instrukciju teiraukit s vietos BD jgaliotojo atstovo Kontakt din lokale BD representant for mer informasjon Aby uzyska instrukcje u ytkowania skontaktuj sie z lokalnym przedstawicielstwem BD Contacte o seu representante local da BD para obter instru es In trukcie z skate u miestneho z stupcu spolo nosti BD Kontakta lokal Becton Dickinson representant f r anvisningar CBbpxxere ce c MecTHMA npencraBHTen Ha BD 3a uncrpykaun Contactati reprezentantul dumneavoastr local BD pentru instruc iuni Talimatlar i in yerel BD temsilcilerinize dan n Obratite se svom lokalnom predstavniku kompanije BD za uputstva na pomuenua MHCTpPYKUN CBsDKeTeCb C MECTHbIM nipencraBureneM komnahnn BD O3inisnin xeprinikri BA ekinine xyriHin HycKay anbIHbI3 Kontaktiraj lokalnog predstavnika BD za upute INTENDED USE The BD ProbeTec ET Neisseria gonorrhoeae GC Amplified DNA Assay when tested with the BD Viper System uses Strand Displacement Amplification SDA technology for the direct qualitative detection of Neisseria gonorrhoeae DNA in endocervical swabs male urethral swabs and in female and male urine specimens as evidence of infection with N gonorrhoeae Specimens may be from symptoma
23. imen If original specimen not available repeat from the processed sample tube For swabs repeat from the processed sample tube If repeat result is either positive or negative interpret as described above If results repeat as indeterminate a new specimen should be requested Determination of GC AC Cutoff The assay and amplification control cutoffs for GC specimen results were determined based on Receiver Operating Characteristic ROC curve analysis of MOTA values obtained with patient specimens male urethral swab female endocervical swab male and female urine tested using both the BD ProbeTec ET CT GC assay and another amplified method during preclinical studies The cutoffs were confirmed in clinical studies by using the BD ProbeTec ET GC assay and culture and another amplified method These studies show that for the majority of the time GC MOTA values greater than 2 000 will indicate the presence of N gonorrhoeae GC MOTA values less than 2000 correlate with negative N gonorrhoeae culture results the majority of the time GC positive results with MOTA values between 2 000 and 10 000 had a decreased likelihood of being true positive compared to results with MOTA values above 10 000 Refer to Figure 3 of the BD ProbeTec ET CT GC Amplified DNA package insert for the distribution of GC MOTA values by specimen type observed in the clinical study The positive predictive value PPV for the data in these figures was calculated using the following
24. is DNA Using Thermophilic Strand Displacement Amplification Mol Cell Probes 10 247 256 Clinical and Laboratory Standards Institute 2005 Approved Guideline M29 A3 Protection of laboratory workers from occupationally 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 Hospital Epidemiol 17 53 80 U 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 Clinical and Laboratory Standards Institute 2006 Approved Guideline C24 A3 Statistical quality control for quantitative measurement procedures principles and definitions 3rd ed CLSI Wayne PA Centers for Disease Control and Prevention 2002 Screening tests to detect Chlamydia trachomatis and Neisseira gonorrhoeae infections MMWR 51 No RR 15 1 29 Manufacturer V robce Producent Fabrikant To
25. ith plenty of water and seek medical advice After contact with skin wash immediately with plenty of water 13 Reagent pouches containing unused Priming Microwells and Amplification Microwells MUST be carefully resealed after opening Verify that a desiccant is present prior to resealing the reagent pouches 14 The plate containing the Amplification Microwells MUST be properly sealed with the black Amplification Sealer Sealing ensures a closed reaction for amplication and detection and is necessary to avoid contamination of the instrument and work area with amplification products Do not remove sealing material from microwells at any time 15 Priming Microwells with residual fluid after transfer of fluid from the Priming Microwells to the Amplification Microwells represent a source of target contamination Carefully seal Priming Microwells with a plate sealer prior to disposal 16 To prevent contamination of the work environment with amplification products use the disposal bags provided in the Reagent Packs to dispose of tested Amplification Microwells Make sure the bags are properly closed before disposal 17 Although dedicated work areas are not required because the BD Viper System design reduces the possibility of amplicon contamination in the testing environment other precautions for controlling contamination particularly to avoid contamination of specimens during processing are necessary 18 Because of the potential for false p
26. ka pomagala za In Vitro Dijagnostiku Temperature limitation Teplotn omezen Temperaturbegr nsning Temperatuurlimiet Temperatuuri piirang L mp tilarajoitus Temp rature limite Zul ssiger Temperaturenbereich Opio eppoKpaciag 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 orpauuueuus Limitare de temperatura Sicaklik s n rlamas Ograni enje temperature Orpaumueune reMneparypel TemnepatypaHb wextey Dozvoljena temperatura Batch Code Lot K d Cislo ar e Batch kode Lot Chargenummer lot Partii kood Er koodi LOT Code de lot Lot Chargencode Chargenbezeichnung Kw ik c rrapr oac Naptida 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 Naptuga Num r lot Lotul Parti Kodu Lot Kod serije Kon naprua nor Tontama kon Lot kod 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 ApiOu c unrpuou aoOtvouc Beteg azonos t sz ma Numero di identificazione paziente Paciento identifikavimo
27. n SDA technology as the amplification method and fluorescent energy transfer ET as the detection method to test for the presence of N gonorrhoeae DNA in clinical specimens 3 5 PRINCIPLES OF THE PROCEDURE The BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescent labeled detector probe The SDA reagents are dried in two separate disposable microwell strips The processed sample is added to the Priming Microwell which contains the amplification primers fluorescent labeled detector probe and other reagents necessary for amplification After incubation the reaction mixture is transferred to the Amplification Microwell which contains two enzymes a DNA polymerase and a restriction endonuclease necessary for SDA The Amplification Microwells are sealed to prevent contamination and then incubated in a thermally controlled fluorescent reader which monitors each reaction for the generation of amplified products The presence or absence of GC is determined by relating the BD ProbeTec ET MOTA Method Other Than Acceleration scores for the sample to pre determined cutoff values The MOTA score is a metric used to assess the magnitude of signal generated as a result of the reaction Each sample and control are tested in two discrete microwells one for N gonorrhoeae and one for the Amplification Control The purpose of the Amplification Co
28. n and Transport sections of this insert 3 Endocervical specimen adequacy can only be assessed by microscopic visualization of columnar epithelial cells in the specimens 4 Collection and testing of urine specimens with the BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay is not intended to replace cervical exam and endocervical sampling for diagnosis of urogenital infection Cervicitis urethritis urinary tract infections and vaginal infections may result from other causes or concurrent infections may occur 5 The BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay for male and female urine testing should be performed on first catch random urine specimens defined as the first 15 20 mL of the urine stream when using neat urine and the UPT During the clinical evaluation testing urine volumes up to 60 mL was included in the performance estimates Dilutional effects of larger urine volumes may result in reduced assay sensitivity The effects of other variables such as mid stream collection have not been determined 6 The effects of other potential variables such as vaginal discharge use of tampons douching and specimen collection variables have not been determined 7 A negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection technical error specimen mix up concurrent antibiotic therapy or the number of organisms in the specimen which may be
29. ntrol is to identify a sample that may inhibit the SDA reaction REAGENTS Each BD ProbeTec ET GC AC Reagent Pack contains Neisseria gonorrhoeae GC Priming Microwells 4 x 96 4 Oligonucleotides gt 7 pmol dNTP 2 35 nmol Detector probe 2 25 pmol with buffers and stabilizers Neisseria gonorrhoeae GC Amplification Microwells 4 x 96 Restriction enzyme 2 15 Units DNA Polymerase gt 2 Units dNTP s 2 80 nmol with buffers and stabilizers Amplification Control AC Priming Microwells 4 x 96 4 Oligonucleotides gt 7 pmol dNTP 2 35 nmol Detector probe 2 25 pmol gt 1 000 copies per reaction of pGC10 linearized plasmid with buffers and stabilizers Amplification Control AC Amplification Microwells 4 x 96 Restriction enzyme 2 15 Units DNA Polymerase gt 2 Units dNTP s 2 80 nmol with buffers and stabilizers NOTE Each microwell pouch contains one desiccant bag BD ProbeTec ET CT GC Control Set 20 CT GC Positive Controls 50 uL dried containing 750 copies per reaction of pCT16 linearized plasmid and 250 copies per reaction of pGC10 linearized plasmid with 2 5 ug Salmon testes DNA 20 CT GC Negative Controls 50 uL dried with 2 5 ug Salmon testes DNA BD ProbeTec ET CT GC Diluent Tubes 400 tubes each containing 2 mL of Sample Diluent which contains potassium phosphate DMSO glycerol Polysorbate 20 and 0 03 Proclin preservative BD ProbeTec ET Diluent CT GC 225 mL Sample Diluent which contains potassium p
30. numeris Pasientens ID nummer Numer ID patentu NUmeroda ID do doente Identifika n slo pacienta Numero de identificaci n del paciente Patientens ID nummer MI Homep Ha nauueura Num r ID pacient Hasta kimlik numaras ID broj pacijenta VWneurucukauvonneiit HoMep nauyeura flauseurriu uneurudpukauwsaneik Help Identifikacijski broj pacijenta Do not reuse NepouZivejte opakovan Ma ikke genbruges Niet opnieuw gebruiken Mitte kasutada korduvalt Ei saa k ytt uudelleen Usage unique Nicht wiederverwenden Mny ro avayxprjoiuomore re Egyszer haszn latos Non riutilizzare Tik vienkartiniam naudojimui Ma ikke gjenbrukes Nie stosowa powt rnie N o reutilizar Nepou vajte opakovane No reusar Far ej teranv ndas He usnonsBaiite oTHoBo A nu se reutiliza Tekrar kullanmay n Ne upotrebljavajte ponovo He wcnonesoBarb noBropo llaltnanan6anbia Ne koristiti ponovo 10 dz wf E 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 8o5og arroors paong aiguAevo amp si io Steriliz l s m dszere etil n oxid Metodo di sterilizzazione ossido di etilene Sterilizavimo b das etileno oksidas Steriliseringsmetode e
31. ositivity with some non gonococcal Neisseria found in the respiratory tract see Limitations of the Procedure 19 contamination of reagents and specimens with respiratory aerosols should be avoided 19 CHANGE GLOVES after removing and discarding caps from lysed samples and controls to avoid cross contamination of specimens If gloves come in contact with specimen or appear to be wet immediately change gloves to avoid contaminating other specimens Change gloves before leaving work area and upon entry into work area 20 In the event of contamination of the work area or equipment with samples or controls thoroughly clean the contaminated area with DNA AWAY or 1 v v sodium hypochlorite and rinse thoroughly with water Allow surface to dry completely before proceeding 21 Clean the entire work area counter tops and instrument surfaces with DNA AWAY or 1 v v sodium hypochlorite on a daily basis Thoroughly rinse with water Allow surfaces to dry completely before proceeding with additional testing 22 Do not use ELIMINase or Alconox for cleaning the BD Viper System 23 When using hydrogen peroxide as a cleaning agent do not use hydrogen peroxide from a bottle that has been open gt 8 days 24 Contact 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 SAMPLE COLLECTION AND TRANSPORT The BD Viper System is designed
32. otja Valmistaja Fabricant Hersteller Kataokeuaotii Gy rt Ditta produttrice Gamintojas Producent Fabricante V robca Tillverkare l ipowsBonuren Produc tor Uretici Proizvo a lipousBonurene Arkapyuibi Use by Spotiebujte do Anvendes fer Houdbaar tot Kasutada enne Viimeink ytt p iv A utiliser avant Verwendbar bis Hugpounia Arj amp nc Felhnaszn 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 Acnonb30Batb no neitin na nananyra 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 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 Aoc Tou urjva 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 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 MN DD AAAA MM
33. tic or asymptomatic females and males A separate Amplification Control is used for inhibition testing SUMMARY AND EXPLANATION Neisseria gonorrhoeae are gram negative oxidase positive diplococci which can be observed in Gram stained smears of urethral discharges usually within neutrophils Culture of N gonorrhoeae can be difficult because the organism does not survive long outside its host and is highly susceptible to adverse environmental conditions such as drying and extreme temperatures Neisseria gonorrhoeae causes acute urethritis in males which if untreated can develop into epididymitis prostatitis and urethral stricture In females the primary site of infection is the endocervix An important complication in females is development of pelvic inflammatory disease which contributes to infertility 2 Asymptomatic infections occur often in females but infrequently in males The current methods for detection of N gonorrhoeae include culture immunoassays non amplified probes and amplified probes 2 The development of amplified methods has demonstrated two advantages over non amplified methods increased sensitivity and applicability to a variety of sample types For identification of GC optimized culture methods continue to be the standard for diagnosing patients with gonococcal infections The BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay when used with the BD Viper System utilizes homogeneous Strand Displacement Amplificatio
34. to guidelines or requirements of local state and or federal regulations or accrediting organizations Refer to CLSI C24 A3 for additional guidance on appropriate internal quality control testing practices The positive control contains 750 copies per reaction of pCT16 linearized plasmid and 250 copies per reaction of pGC10 linearized plasmid Both organisms have multiple copies of the target The BD ProbeTec ET amplification reaction volume is 100 uL of rehydrated control Correct positioning of the microwell strips is important for proper result reporting Refer to the BD Viper Instrument User s Manual Addendum for correct microwell strip positioning The CT GC positive and CT GC negative control must test as positive and negative respectively in order to report patient results If controls do not perform as expected the assay run is considered invalid and patient results will not be reported by the instrument If the QC does not meet the expected results repeat the entire run using a new set of controls new microwells and the processed specimens If the repeat QC does not provide the expected results contact Technical Services See Interpretation of Results D Quality Control Preparation NOTE The BD ProbeTec ET CT GC Controls and Diluent should be at room temperature prior to use 1 For each run plate to be tested prepare a fresh CT GC Negative Control Tube and a fresh CT GC Positive Control Tube If a plate contains more than on
35. tve Representante autorizado en la Comunidad Europea Auktoriserad representant i EU Oropusupan npencraauren B EU Reprezentant autorizat in Uniunea European Avrupa Toplulu u Yetkili Temsilcisi Ovla eni predstavnik u Evropskoj zajednici YnonHoMoYeHHbI npencraBurere B EBponelickoM coo6wectsBe Espona KaybimgacTbiFbiHgaFbi y kineTTi ekin 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 Giayvoorikr rarpikrj OUOkEun In vitro diagnosztikai orvosi eszk z Dispositivo medico diagnostico in vitro In vitro diagnostikos prietaisas In vitro diagnostisk medisinsk utstyr Urz dzenie 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 Megu nnckn ypeg 3a DMarHOCTHkKa nH BUTpO Aparatur medical de diagnosticare in vitro In Vitro Diyagnostik Tibbi Cihaz Medicinski ure aj za in vitro dijagnostiku MeguunucKuid npu 6op gna quvarHoctuky in vitro XacaHgbi xarga ga xypriseriH MEANUNHANDIK AwarHocruka acna Medicins
36. tylenoksid 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 Meton Ha cTepunusalna eTuneHos okcug Metod de sterilizare oxid de etilen Sterilizasyon y ntemi etilen oksit Metoda sterilizacije etilen oksid Meron crepunu3zaunu stunexoKkcna Crepunusaunsa oni arunen TOTbIFbI Positive control Pozitivn kontrola Positiv kontrol Positieve controle Positiivne kontroll Positiivinkontrolli Contr le positif Positive Kontrolle 8 rik c Aeyxoc Pozit v kontroll Controllo positivo Teigiama kontrol Positiv kontroll Kontrola dodatnia Controlo positivo Pozit vna kontrola Control positivo l lonoxureneH kourpon Etalon pozitiv Pozitif kontrol Pozitivna kontrola l l onoxwreribHellt KOHTponb XKaTbiMAbi Gaxbinay Negative control Negativn kontrola Negativ kontrol Negatieve controle Negatiivne kontroll Negatiivinkontrolli Contr le n gatif Negative Kontrolle ApvririK g Xeyxoc Negat v kontroll Controllo negativo Neigiama kontrol Negativ kontroll Kontrola ujemna Controlo negativo Negat vna kontrola Control negativo Orpuuarenea KoHTpon Etalon negativ Negatif kontrol Negativna kontrola OrpuuarensHsi KOHTponb HeraruBrik 6akbinay Collection date Datum odb ru Opsamlingsdato Afnamedatum Kogumiskuup
37. u n teste n testleri i in yeterli miktarda i erir Sadr aj dovoljan za n testova Hocrarouuo gna n recros a n recrrepi ywiH xerxinikri Sadr aj za n testova Consult Instructions for Use Prostudujte pokyny k pou it Lees brugsanvisningen Raadpleeg gebruiksaanwijzing Lugeda kasutusjuhendit Tarkista kaytt ohjeista Consulter la notice d emploi Gebrauchsanweisung beachten upfouAeurs re ric oonyies xprjonc Olvassa el a haszn lati utas t st Consultare le istruzioni per l uso Skaitykite naudojimo instrukcijas Se i bruksanvisningen Zobacz instrukcja uzytkowania Consulte as instruc es de utilizac o Pozri Pokyny na pou vanie Consultar las instrucciones de uso Se bruksanvisningen Hanpasgere cnpaska B wHerpykuuure 3a ynorpe6a Consulta i instruc iunile de utilizare Kullan m Talimatlari na ba vurun Pogledajte uputstvo za upotrebu CM pykoBoncrBo no skcnnyarauw llalianaHy HyCcKaynbiFbIMeH TaHbICBITI aribiHl3 Koristi upute za upotrebu 11 ud Becton Dickinson and Company ece Benex Limited 7 Loveton Circle Rineanna House Sparks MD 21152 USA Shannon Free Zone 800 638 8663 Shannon County Clare Ireland www bd com ds Alconox is a trademark of Alconox Inc ELIMINase is a trademark of Decon Laboratories Inc Proclin is a trademark of Rohm and Haas Co DNA AWAY is a trademark of Molecular BioProducts Inc ATCC is a trademark of the American Type C
38. ulture Collection BD BD Logo ProbeTec and Viper are trademarks of Becton Dickinson and Company 2010 BD
39. up to the UPT within 8 h of collection provided the urine has been stored at 2 30 C Urine can be held for up to 24 h prior to transfer to the UPT provided that the urine has been stored at 2 8 C Wear clean gloves when handling the UPT and the urine specimen If gloves come in contact with the specimen immediately change gloves to prevent contamination of other specimens 1 After the patient has collected the urine sample label the urine collection cup 2 Open the Urine Preservative Transport Kit and remove the UPT and the transfer pipette Label the UPT with the patient identification and date time collected 3 Hold the UPT upright and firmly tap the bottom of the tube on a flat surface to dislodge any large drops from inside the cap Repeat if necessary 4 Uncap the UPT and use the transfer pipette to transfer urine into the tube The correct volume of urine has been added when the fluid level is between the black lines on the fill window on the UPT label This volume corresponds to approximately 2 5 3 45 mL of urine DO NOT overfill or under fill the tube 5 Discard the transfer pipette NOTE The transfer pipette is intended for use with a single specimen 6 Tighten the cap securely on the UPT 7 Invert the UPT 3 4 times to ensure that the specimen and reagent are well mixed UPT Storage and Transport Store and transport urine specimens in UPT at 2 30 C and process within 30 days of collection Specimens may be
40. ure wo o og UU OW ON Monitoring for the Presence of DNA Contamination Refer to the BD Viper Instrument User s Manual Addendum INTERPRETATION OF TEST RESULTS The BD ProbeTec ET Neisseria gonorrhoeae Amplified DNA Assay uses fluorescent energy transfer as the detection method to test for the presence of N gonorrhoeae in clinical specimens All calculations are performed automatically by the instrument software The presence or absence of N gonorrhoeae is determined by relating the BD Viper MOTA scores for the specimen to pre determined cutoff values The MOTA score is a metric used to assess the magnitude of signal generated as a result of the reaction The magnitude of the MOTA score is not indicative of the level of organism in the specimen If assay controls are not as expected patient results should not be reported See QC section for expected control values Reported results are determined as follows For the GC AC Reagent Pack N gonorrhoeae Result Interpretation with AC GC AC MOTA MOTA Score Score Report Interpretation Result 210 000 Any N gonorrhoeae Positive for N gonorrhoeae N gonorrhoeae organism Positive detected by SDA viability and or infectivity cannot be inferred since target DNA may persist in the absence of viable organisms 2000 Any N gonorrhoeae N gonorrhoeae likely Supplemental testing may be Low Positive 2 3 9 999 detected by SDA useful for verifying presence of N gonorrhoeae 2 2000
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