試薬添付文書
Contents
1. 3 1 2 121 C 20 3 1 2 8C 2 122. B F 4 4 hCG 1 7 2 8C 20 C E TOSOH II HCG
3. 90 90 4 5 6 E TOSOH II HCG E TOSOH II HC GRAN E TOSOH TII SUB II E TOSOH Il E TOSOH I
4. 200 000 mIU mL 1 000 000 mIU mL 200 000 mIU mL 5 hCG 100 free hCG 8 subunit 0 04 hFSH 0 06 hLH 0 7 hTSH 0 06 6 ASE y EIA x y 0 991 x 2 931 r 0 999 n 48 y 1 046 x 0 276 r 0 999 n 48 2 3 x amp 8 E FETAY VE y x y 0 983 x 0 002 r 0 999 n 159 1 1
5. AIA 1200 AIA 600 1 E TOSOH II HCG 5 6 HCG HCG E TOSOH II HCG E TOSOH Il HCG 1 E TOSOH II HCG 2 EFA b TOSOH I HC GREE RIK E TOSOH II SUBI 1 E TOSOH II 4 2 E TOSOH II EFA TOSOH Il E TOSOH TI hCG 1 1
6. 400 mIU mL 2 000 mIU mL 1 5 ex AILA 1800 5 1 5 HCG 029 Y Ar 8 Calibrator Lot 2003405802070000 Rate 70 60 50 40 30 20 10 6 0 20 40 60 80 108 120 140 160 180 200 220 Conc 1 l TOSOH II HCG hCG hCG
7. 2 3 hCG n mIU mL 137 lt 0 5 24 lt 0 5 4 7 36 8 11 28 12 20 25 5 400 169 000 21 40 89 3 440 69 700 R 24 lt 2 5 4 7 30 1 210 475 000 8 11 24 21 900 709 000 12 20 26 2 890 193 000 21 40 89 1 680 74 300 612 187 000 17 700 315 000 2 1 2 SI hCG mIU mL Si IU L IU hCG L mIU hCG mL x 1 0
8. hCG human Chorionic Gonadotropin HERE TC 38000 7 w g LH FSH 5H TSH w 8 LH hCG 3 hCG 4 5 hCG 1 1 BE TOSOH II HCG FU Rate 5 nmol L s 2 BE TOSOH IE HCG 1 B TOSOH II HCG 2 FU
9. 3 1 2 3 4 5 6 E TOSOH II HCG 100 L E TOSOH II HCG 5 50 pp 37 C 10 B F 363 nm 447 nm BOS Te se ee ane eee ee O O 90 DO
10. 390 mg dL 17 mg dL 18 mg dL 1 600 mg dL 5 0 g dL 20 mg dL 100 U mL EDTA E TOSOH Il HC GRAFICOS 8C 20 C 2 8 C 15 25 C 1 1 2 3 E
11. 100 1 0 mL x24 100 mL x24 100 mL x2 100 mL x4 100 mL x4 0015356 EFA F TOSOH IIHCG E rTOSOH IIHCG BAIR 0015556 0015968 E TOSOH II E TOSOH I E TOSOH Il 0015955 E TOSOH II 0015956 E TOSOH UATE 1 Hussa R O Biosynthesis of human chorionic gonadotropin Endocrine Rev 3 268 294 1980 2 Birken S Fetherston J Canfield R and Boime J The amino acid sequences of the peptide contained in the a and subunits of human choriogonadotropin J Biol Chem 256 1816 1820 1981 3 Tojo S The biology and chemistry of placental peptide hormones and their climical relevances Asia Oceania J Obstet Gynecol 6 15 39 1980 4 Armstrong E G Ehrlich P H Birken S Schlatterer J P Siris E Hembree W C and Canfield R E Use of a highly sensitive and specific immunoradiometric assay for detection of human chorionic gonadotropin in urine of normal nonpregnant and pregnant individuals J Clin Endocrinol Metab 59 867 874 1984 5 Mizouchi T Nishimura R Taniguchi T Utsunomiya T Mochizuki M Derappe C and Kobata A Comparison of carbohydrate stru
12. AILA 1200 AIA 600 10 2 RCG 1 BEIA IEMA 3 hCG hCG 4 5 2 2 1 RIA IEMA hCG hCG OR ARR
13. 7 hCG HAMA Human Anti mouse Antibody 9 hCG hCG 6 7 2 1 HIV HBV HCV 2
14. Bruksanvisning p flera spr k finns att tillg p v r webbplats www tosohbioscience eu under rubriken Service amp Support En pappersversion kan erh llas per fax 32 13 66 47 49 eller e post info raqa eu tosoh com Denna produkt inneh ller material med humant eller animalt ursprung och skall behandlas som potentiellt infekti s 1007071001 039C Rev 03 09 Attention For North and South American Customers Please refer to the AIA AAM Docs on CD for the appropriate information Para los Clientes en Norte y Sur Am rica favor de referirse a los documentos AIA AAM en Disco para la informaci n apropiada Aos clientes da Am rica do Norte e Am rica do Sul favor consultar os documentos do AIA AAM que est o em CD para informa es adequadas Pour les clients en Am rique du Nord et en Am rique du Sud veuillez consulter les documents AIA AAM sur le CD pour P information appropri e ST AIA PACK HCG For Quantitative Measurement of human chorionic gonadotropin hCG in Serum Heparinized Plasma or Urine NAME AND INTENDED USE ST AIA PACK HCG is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of human chorionic gonadotropin intact hCG in human serum heparinized plasma or urine on TOSOH ATA System Analyzers SUMMARY AND EXPLANATION OF TEST Human chorionic gonadotropin hCG is a glycoprotein which like LH FSH and TSH consists of alpha and beta chains It co
15. 4 E TOSOH II 1 BE TOSOH II OA 100 mL 15 25 C 3 Al 2 8 C 7 5 HK E TOSOH TII 1 2 5 15 25 C 30 6 E TOSOH II 1 5 15 25 C 30 2 xkl 2
16. TOSOH Il HCG 15 25 C 1 2 8 C 7 E TOSOH Il HCG 2 8 C 7 15 25 C A ST 2 8C 90 E TOSOH ITHCG 1 2 2 8 C 1 E TOSOH II HCG WHO hCG WHO 3rd IS 75 537
17. hCG FU 0 15 1 5 nmol L s mIU mL FU FU A B C A 2 FU B 1 FU c 2 hCG nmol L s nmol L s mIU mL 2 hCG 15 350 mIU mL LE 100 20 LACT HCG E TOSOH II HCG 3 hCG 15 350 mIU mL 10 15 k4 MIRON 0 5 400 mIU mL 2 5 2 000 mIU mL 5 0 5 400 mIU mL 0 5 mIU mL 2 5 mIU mL 1 2 1 FU y 2 x SD 10
18. Support Servis in podpora V papirni obliki jih lahko prejmete po faksu 32 13 66 47 49 ali elektronski po ti info raqa eu tosoh com Ta izdelek vsebuje materiale Cloveskega ali zivalskega izvora kar lahko privede do okuzb Eri keeltes kasutusjuhendid on saadaval meie veebilehel www tosohbioscience eu alajaotuses Service amp Support Paberkandjal versiooni saab tellida faksinumbril 32 13 66 47 49 v i e posti teel info raga eu tosoh com y debe ser tratado como producto potencialmente infeccioso A See toode sisaldab inim v i loomse p ritoluga aineid ning v ib olla nakkusohtlik Les instructions d utilisation sont disponibles en plusieurs langues sur notre site web www tosohbioscience eu dans la rubrique Service amp Support Vous pouvez obtenir un exemplaire papier par fax au n 32 13 66 47 49 ou par e mail al adresse info raqa eu tosoh com Ce produit contient des substances animales ou humaines et doit par cons quent tre trait comme un produit potentiellement infectieux N vod na pou itie vo viacer ch jazykoch je dostupn na na ej web str nke www tosohbioscience eu v sekcii Service amp Support Vytla en verziu mo no z ska faxom 32 13 66 47 49 alebo cez e mail info raqa eu tosoh com A Tento vyrobok obsahuje material z ludskych alebo zvieracich zdrojov a malo by sa s nim zaobchadzat ako s potenci lne infek n m materi lom
19. Eiropas klienti Klienci europejscy Clientes europeus Clientii europeni Evropski kupci Eur pski z kazn ci Europeiska kunder bg Muctpyxyun sa ynorpe a Ha pa3sAM4HN CSYETL Ca Ha pasnoxrokenne Ha Hanna ye6calit www tosohbioscience eu B pasgena Homon n nop oka Service amp Support XaprneHo KONNE MOKE Ha b Te nOTyueHo Ha fax 32 13 66 47 49 mm e mail info raqa eu tosoh com Tosu HpOXyKT CbybpxKa MaTepuana C LOBeWIKH UAM KUBOTUHCKM HPOM3XOA U TpA BA Ha Obe TperHpaH KATO TOTeHTTYfaIHO UH PeKIMOSEH webovych str nk ch www tosohbioscience eu v sekci Service amp Support TiStenou verzi m ete obdr et faxem slo 32 13 66 47 49 nebo e mailem info raqa eu tosoh com A Tento v robek obsahuje materi ly poch zej c ze zv at nebo od lid a je t eba s nimi zach zet jako s potenci ln infek n mi N vod k pou it v r zn ch jazyc ch je dostupn na na ich Flersprogede brugsanvisninger findes p vores hjemmeside wwwrtosohbioscience eu under Service amp Support sektionen Trykte brugsanvisninger kan rekvireres pr fax 32 13 66 47 49 eller e mail info raqa eu tosoh com A Dette produkt indeholder menneskelige eller animalske udgangsmaterialer og b r behandles som potentielt infekti st de Bedienungsanleitungen in verschiedenen Sprachen sind auf unserer Webseite www tosohbioscience eu Im Kapitel Service amp Support erh ltlich Ein Pap
20. J B ed W B Saunders Co Philadelphia p 680 1979 7 Brody S Carlstrom G Immunoassay of Human Chorionic Gonadotropin in Normal and Pathologic Pregnancy J Clin Endocrinol Metab 22 564 1962 8 Batzer F Hormonal Evaluation of Early Pregnancy Fertility and Sterility 34 pp 1 1980 9 Braunstein G D First trimester Chorionic Gonadotropin Measurements as an Aid in the Diagnosis of Early Pregnancy Disorders Am J Obst Gynec 131 25 1978 10 DiPietro D L Ectopic Pregnancy Interpreting HCG Levels Laboratory Management 19 11 1981 11 Kosasa T S Measurement of Human Chorionic Gonadotropin J Reprod Med 26 201 1981 12 Lenton E et al Plasma Concentrations of Human Gonadotropin From Time of Implantation Until Second Week of Pregnancy Fertility and Sterility 37 773 1982 13 Young D Effects of Drugs on Clinical Laboratory Tests 3rd Edition Washington DC American Association for Clinical Chemistry Press 1990 14 Hartree A S Shownkeen R C Stevens V C et al Studies of the humanchorionic gonadotropin like substance of human pituitary glands and its significance J Endocrinol 96 115 126 1983 15 Stenman U H Alfthan H Ranta T et al Serum level of human chorionic gonadotropin in nonpregnant women and men are modulated by gonadotropin releasing hormone and sex steroids J Clin Endocrinol Met 64 730 736 1987 EC E El z CE European Confor
21. PROCEDURE For diagnostic purposes the results obtained from this assay should be used in conjunction with other data e g symptoms results of other tests clinical impressions therapy etc Using ST AIA PACK HCG the highest measurable concentration of human chorionic gonadotropin in serum or heparinized plasma specimens without dilution or in urine specimens diluted by 5 fold with AIA PACK HCG SAMPLE DILUTING SOLUTION is 400 mIU mL which corresponds to 2 000 mIU mL in original urine specimens and the lowest measurable concentration in serum or heparinized plasma specimens without dilution or in urine specimens diluted by 5 fold with AIA PACK HCG SAMPLE DILUTING SOLUTION is 0 5 mIU mL assay sensitivity which corresponds to 2 5 mIU mL in original urine specimens e Although the approximate value of the highest calibrator is 200 mIU mL the exact concentration may be slightly different Although hemolysis has an insignificant effect on the assay hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution Lipemia has an insignificant effect on the assay except in the case of gross lipemia where spatial interference may occur e Specimens from patients taking medicines and or medical treatment may show erroneous results Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti mouse antibodie
22. Reconstituted substrate solution is stable for 3 days at 18 25 C or 7 days at 2 8 C Working diluent and wash solutions are stable for 30 days at 18 25 C Reagents should not be used if they appear cloudy or discolored SPECIMEN COLLECTION AND HANDLING Serum heparinized plasma or urine is required for the assay EDTA and citrated plasma SHOULD NOT BE USED A urine sample is collected without preservatives e If using serum a venous blood sample is collected aseptically without additives Store at 18 25 C until a clot has formed usually 15 45 minutes then centrifuge to obtain the serum specimen for assay If using heparinized plasma a venous blood sample is collected aseptically with designated additive Centrifuge and separate plasma from the packed cells as soon as possible Specimen types should not be used interchangeably during serial monitoring of an individual patient Measured concentrations may vary slightly between sample types in certain patients All urine specimens should be diluted by more than 5 fold with AIA PACK HCG SAMPLE DILUTING SOLUTION Urine specimen without dilution may be recovering low Samples may be stored at 2 8 C for up to 24 hours prior to analysis If the analysis cannot be done within 24 hours the sample should be stored frozen at 20 C or below for up to 60 days Repeated freeze thaw cycles should be avoided Turbid serum samples or samples containing particulate matter should be centrifuged
23. prior to testing Prior to assay bring frozen samples to 18 25 C slowly and mix gently The sample required for analysis is 50 L PROCEDURE For the AIA Nex IA AIA 21 AIA 600 II AIA 1800 AIA 2000 and AIA 360 please refer to their Operator s Manual for detailed instructions Reagent Preparation A Substrate Solution Bring all reagents to 18 25 C before preparing the working reagent Add the entire contents of the AIA PACK SUBSTRATE RECONSTITUENT II 100 mL to the lyophilized AIA PACK SUBSTRATE REAGENT II mix thoroughly to dissolve the solid material B Wash Solution Add the entire contents of the ALA PACK WASH CONCENTRATE 100 mL to approximately 2 0 L of CAP Class I or NCCLS Type I Reagent Grade water mix well and adjust the final volume to 2 5 L C Diluent Add the entire contents of the AIA PACK DILUENT CONCENTRATE 100 mL to approximately 4 0 L of CAP Class I or NCCLS Type I Reagent Grade water mix well and adjust the final volume to 5 0 L Il Calibration Procedure A Calibration Curve The calibrators for use with the ST AIA PACK HCG have been standardized on WHO 3rd IS 75 537 1975 The calibration curve for ST AIA PACK HCG is stable for up to 90 days Calibration stability is monitored by quality control performance and is dependent on proper reagent handling and TOSOH AIA System maintenance according to the manufacturer s instructions Recalibration may be necessary more frequently if controls are out o
24. then incubated with a fluorogenic substrate 4 methylumbelliferyl phosphate 4MUP The amount of enzyme labeled monoclonal antibody that binds to the beads is directly proportional to the hCG concentration in the test sample A standard curve is constructed and unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK HCG Cat No 0025256 Plastic test cups containing lyophilized twelve magnetic beads coated with anti hCG mouse monoclonal antibody and 100 gL of anti hCG mouse monoclonal antibody to hCG conjugated to bovine alkaline phosphatase with sodium azide as a preservative MATERIALS REQUIRED BUT NOT PROVIDED The following materials are not provided but are required to perform human chorionic gonadotropin analysis using the ST AIA PACK HCG Cat No 0025256 on the TOSOH AIA System Analyzers They are available separately from TOSOH Materials Cat No AIA Nex IA or AIA 21 0018539 AIA Nex IA or AJA 21 LA 0018540 AJA 1800 ST 0019836 AIA 1800 LA 0019837 ATA 2000 ST 0022100 AIA 2000 LA 0022101 AIA 600 II 0019014 AIA 600 II BCR 0019328 ATA 360 0019945 AIA PACK SUBSTRATE SET II 0020968 AIA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK HCG CALIBRATOR SET 0020356 ZERO CALIBRATOR 0 mIU mL POSITIVE CALIBRATOR 200 mIU mL approx AJA PACK HCG SAMPLE DILUTING SOLUTION 0020556 AIA PACK WASH CONCENTRATE 0020955 AIA PACK DILUENT CONCENTRATE 0020956 SAMPLE CUPS 0018581 ATA P
25. 10 181 79 101 5 2 5 10 89 55 89 10 99 5 1 0 10 35 82 36 69 102 4 Serum B2 none 374 30 7 5110 280 73 284 64 101 4 5 0 10 187 15 190 42 101 7 2 5 10 93 58 94 45 100 9 1 0 10 37 43 39 60 105 8 Serum C2 none 384 60 7 5 10 288 44 291 43 101 0 5 0 10 192 30 192 51 100 1 2 5 10 96 15 99 13 103 1 1 0 10 38 46 40 63 105 6 b 2 Dilution urine Two urine samples containing high concentrations of hCG were serially diluted with AIA PACK HCG SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery mIU mL mIU mL Urine A2 none 394 00 75 10 295 50 313 63 106 1 5 0 10 197 00 197 48 100 2 2 5 10 98 50 99 96 101 5 1 0 10 39 40 40 03 101 6 Urine B2 none _ 392 99 7 5710 294 74 286 43 97 2 5 0 10 196 49 183 94 93 6 2 5710 98 25 92 58 94 2 1 0 10 39 30 38 45 97 8 PRECISION a Within run precision was determined using three controls in a total of 20 runs Within each run one set of duplicates per control was assayed The mean of each duplicate was used to obtain the pooled standard deviation SD which was then used to calculate the coefficient of variation CV Sample Mean Pooled SD CV mIU mL mIU mL Serum A3 5 61 0 112 2 0 Serum B3 109 39 2 023 19 Serum C3 274 16 4 833 18 b Total precision was determined by the duplicate assay of three controls in 20 separate runs The means of each run were used to calculate the pooled standard deviation SD and coefficient of variation C
26. 1007071001 039C 70 318 HCG Immuno Enzymometric Assay III E TOSOH HHCG xy SA ST AIA PACK HCG 1007071001 039C 2009 3 3 2008 8 2 20100BZZ00112000 OE TOSOH IL HCG EIA NCO 1 2 3 4 5 6 HBs HIV HCV
27. ACK DETECTOR STANDARDIZATION TEST CUP 0020970 AIA PACK SAMPLE TREATMENT CUP 0020971 Additional Requirements for AIA Nex IA AIA 21 only PIPETTE TIPS 0018552 PRELOADED PIPETTE TIPS 0018583 Additional Requirements for AIA 600 II AIA 1800 and AIA 2000 PIPETTE TIPS 0019215 TIP RACK 0019216 PRELOADED PIPETTE TIPS 0022103 Only materials obtained from TOSOH should be used Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on TOSOH materials ROW AND PRECAUTIONS The ST AIA PACK HCG is intended for in vitro diagnostic use only A Test cups from different lots or different assays should not be mixed within a tray 3 The ST AIA PACK HCG contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides When disposing of such reagents always flush with large volumes of water to prevent azide build up 4 Human serum is not used in the preparation of this product however since human specimens will be used for samples and other quality control products in the lab may be derived from human serum please use standard laboratory safety procedures in handling all specimens and controls 5 Do not use beyond the expiration date 6 The ST AIA PACK HCG has been designed so that the high dose hook effect is not a problem for the vast majority of samples Serum or heparinized plasma samples with hCG concentrations between 400 and 200 000 mIU mL
28. V Sample Mean Pooled SD CV mlU mL mIU mL Serum A3 5 61 0 177 3 2 Serum B3 109 39 3 603 3 3 Serum C3 274 16 9 564 3 5 CORRELATION The correlation between serum x and heparinized plasma y on ST AJA PACK HCG was carried out using 159 patient specimens Slope 0 983 y Intercept 0 002 Correlation Coefficient 0 999 Range of Samples 0 5 397 6 Number of Samples 159 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as hCG If these compounds are present in the specimen at the same concentration as hCG the final result will be increased by these percentages Compound Cross reactivity hCG 100 free hCG B subunit 0 04 hFSH 0 06 hLH 0 7 hTSH 0 06 SENSITIVITY The minimal detectable concentration MDC of human chorionic gonadotropin is estimated to be 0 5 mIU mL which corresponds to 2 5 mIU mL in original urine specimens dilution factor 5 The MDC is defined as the concentration of hCG which corresponds to the rate of fluorescence that is two standard deviations from the mean rate of fluorescence of 20 replicate determinations of a ZERO CALIBRATOR INTERFERENCE Interference is defined for the purposes of this study as recovery outside of 10 of the known specimen mean concentration after the following substances are added to human specimens Hemoglobin up to 390 mg dL free bilirubin up to 17 mg dL a
29. cture between human chorionic gonadotropin present in urine of patients with trophoblastic diseases and healthy individuals Jpn J Cancer Res Gann 76 752 759 1985 6 Hartree A S Shownkeen R C Stevens V C et al Studies of the humanchorionic gonadotropin like substance of human pituitary glands and its significance J Endocrinol 96 115 126 1983 7 Stenman U H Alfthan H Ranta T et al Serum level of human chorionic gonadotropin in nonpregnant women and men are modulated by gonadotropin releasing hormone and sex steroids J Clin Endocrinol Met 64 730 736 1987 252 1123 2743 1 0120 17 1200 TEL 0467 76 5384 FAX 0467 79 2550 TosoH 3 8 2 TEL 03 5427 5181 FAX 03 5427 5220 TosoH 2 ST AIA PACK HCG 3 Espone cku norpe nrern Evrop t z kazn ci gt Europ iske kunder Europ ische Kunden European customers Evpwnaior TEA gc Clientes europeos Euroopa kliendid Consommateurs europ ens Eur pai gyfelek Clienti europei Europos klientai
30. ent C3 A3 Volume 11 No 13 originally approved asa guideline by NCCLS in October 1997 3 If a specimen human chorionic gonadotropin concentration is found to be greater than 400 mIU mL in serum or heparinized plasma or 2 000 mIU mL in urine the specimen should be diluted with the AJA PACK HCG SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 400 mIU mL serum or heparinized plasma or 2 000 mIU mL urine is 1 10 or 1 100 It is desirable to dilute the specimen so that the diluted specimen reads between 5 and 400 mIU mL in serum or heparinized plasma and 25 and 2 000 mIU mL in urine The dilution factor should be entered into the software For further information on the dilution of specimens refer to the TOSOH AIA System Operator s Manual 4 The TOSOH AIA System Analyzers can store two different calibration curves for each analyte at one time Therefore up to two different lots of ST AIA PACK HCG test cups can be used during the same run 5 If the assay specifications for this test are not ready in the system software the specifications must be entered under test code 070 CALCULATION OF RESULTS The TOSOH AIA System Analyzers perform all sample and reagent handling operations automatically The TOSOH AIA System Analyzers read the rate of fluorescence produced by the reaction and automatically convert the rate to human chorionic gonadotropin concentrat
31. f the established range for this assay or when certain service procedures are performed e g temperature adjustment sampling mechanism changes maintenance of the wash probe or detector lamp adjustment or change For further information regarding instrument operation consult the TOSOH AIA System Operator s Manual A sample calibration curve from AIA 1800 follows and shows the algorithm used for calculating results The concentration range of the calibration curve is displayed in 1 5 of assay range in urine specimens The concentrations of urine specimens are calculated by multiplying the concentrations obtained on the calibration curve with the dilution factor AIA Nex IA AJA 21 ATA 600 II ATA 1800 and ATA 2000 will automatically calculate the concentrations of urine specimens using the dilution factor and report the results HOG 0291 Calibrator Lot 2603405802070000 Y Ax B Rate 70 60 50 40 30 20 10 r E 6 20 40 60 80 108 120 140 160 180 200 220 Conc B Calibration Procedure 1 Refer to the appropriate TOSOH AIA System Operator s Manual for the procedural instructions 2 Verify that both the calibrator lot and concentration numbers have been correctly entered into the software 3 Calibrators for ST AIA PACK HCG are provided ready for use TOSOH recommends that all calibrators be run in triplicate C Calibration Acceptability Criteria 1 The mean rate for the ZERO CALIBRATOR should be lt 3 0 SGD 2 Since
32. ierexemplar erhalten Sie auf schriftliche Anfrage an Faxnummer 32 13 66 47 49 oder per E Mail an info raqa eu tosoh com Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle Infektionsquelle behandelt werden oroOgotot nac www tosohbioscience eu ctnv EVO no Service amp Support Mnopeite va AdBete thy vrurrn popoh vToPadAovtacg aitnon p ow pas otov apiOuo 32 13 66 47 49 y p cw nAektpovikod taxvdpouciov info raga eu tosoh com A To npo v avt TEPLEXEL vlix avOpantvys A CwiKiys oAvopariko Oa Bptr tc Odnyies xpnons oe noi s yA ouEs otn dtaductvany CC A Hasznalati utasitas t bb nyelven el rhet websz jtunkon www tosohbioscience eu a Service amp Support Szolg ltat s s T mogat s szekci alatt Nyomtatott v ltozat ig nyelhet faxon a 32 13 66 47 49 es telefonsz mon vagy e mailben info raqa eu tosoh com A Ez a term k emberi vagy llati forr sanyagokat tartalmaz ez rt lehets gesen fert z k nt kell kezelni T Istruzioni per 1 Uso in diverse lingue sono disponibili sul nostro sito web www tosohbioscience eu alla sezione Service amp Support Versione cartacea pu essere richiesta via fax al 32 13 66 47 49 o via e mail a info raqa eu tosoh com A Il prodotto contiene materiali di origine umana o animale e va trattato come potenzialmente infettivo Naudojimo instr
33. ion in mIU mL For samples requiring dilution the AIA Nex IA AIA 21 ATA 600 II AIA 1800 and AIA 2000 will automatically perform dilutions and calculate results if the dilution factors are entered into the software Dilution factors may be entered into the Test File or pre defined dilution factors may be selected in Specimen Processing EVALUATION OF RESULTS Quality Control In order to monitor and evaluate the precision of the analytical performance it is recommended that commercially available control samples should be assayed according to the local regulations The minimum recommendations for the frequency of running internal control material are After calibration three levels of the internal control are run in order to accept the calibration curve The three levels of controls are repeated when certain service procedures are performed e g temperature adjustment sampling mechanism changes maintenance of the wash probe or detector lamp adjustment or change After daily maintenance at least two levels of the control should be run in order to verify the overall performance of the TOSOH AJA System Analyzers If one or more control sample value s is out of the acceptable range it is necessary to investigate the validity of the calibration curve before reporting patient results Standard laboratory procedures should be followed in accordance with the strict regulatory agency under which the laboratory operates LIMITATIONS OF THE
34. mity In vitro diagnostic medical device LOT Batch code Lot number Su Catalogue number Part number VD Manufacturer Supplied by TOSOH CORPORATION Shiba koen First Bldg 3 8 2 Shiba Minato ku Tokyo 105 8623 Japan Phone 81 3 5427 5181 Fax 81 3 5427 5220 TOSOH EUROPE N V Transportstraat 4 B 3980 Tessenderlo Belgium Phone 32 13 66 88 30 Fax 32 13 66 47 49 TOSOH BIOSCIENCE INC 6000 Shoreline Ct Suite 101 South San Francisco CA94080 USA Phone 1 650 615 4970 Fax 1 650 615 0415 Phone 800 248 6764 Fax 800 685 7595 4 Consult instructions for use Temperature limitation Edme Authorized representative in the European Community by NET Net volume after reconstitution for lyophilized material Use by date
35. nd conjugated bilirubin up to 18 mg dL do not interfere with the assay Lipemia as indicated by triglyceride concentration up to 1 600 mg dL does not interfere with the assay Ascorbic acid up to 20 mg dL does not interfere with the assay Protein as indicated by human albumin concentration up to 5 0 g dL does not interfere with the assay bi up to 100 U mL does not interfere with the assay REFERENCES Swaminathan N Bahl O P Dissociation and Recombination of the Subunits of Human Chorionic Gonadotropin Biochem Biophys Res Commun 40 422 1970 2 Pierce J G Eli Lilly Lecture The Subunits of Pituitary Thyrotropin Their Relationship to Other Glycoprotein Hormones Endocrinology 89 1331 1971 3 Pierce J G et al Biologically Active Hormones Prepared by Recombination of the Alpha Chain of Human Chorionic Gonadotropin and the Hormone Specific Chain of Bovine Thyrotropin or of Bovine Luteinizing Hormone J Biol Chem 246 2321 1971 4 Reuter A M et al Serum Concentrations of Human Chorionic Gonadotropin and its Alpha and Beta Subunits 1 During Normal Single and Twin Pregnancies Clin Endo 13 305 1980 5 Braunstein G D et al Serum Human Chorionic Gonadotropin Levels Throughout Normal Pregnancy Am J Obstet Gynecol 126 678 1976 6 Krieg A F Pregnancy Test and Evaluation of Placental Function In Clinical Diagnosis and Management by Laboratory Methods 16th ed Henry
36. ntains approximately 30 carbohydrate by weight J The alpha chains are virtually identical in all four hormones whereas the beta chains are different and determine both the specific biological activity and immunological characteristics of each hormone 2 3 In the case of hCG however the amino acid sequence of the beta chain displays a considerable degree of homology with that of LH 4 making it difficult to achieve the required assay specificity based on conventional antibody techniques The use of monoclonal antibody technology has made it possible to produce an essentially unlimited supply of antibody of precisely defined specificity HCG is produced by the placenta shortly after implantation 5 7 and increases at a geometric rate until it reaches a peak near the end of the first trimester This makes it an excellent marker for the confirmation of pregnancy and or monitoring its course thereafter when necessary 5 8 Other conditions associated with elevated serum hCG concentrations are neoplasms of trophoblastic and non trophoblastic origin 9 12 PRINCIPLE OF THE ASSAY The ST AIA PACK HCG is a two site immunoenzymometric assay which is performed entirely in the AIA PACK test cups HCG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme labeled monoclonal antibody in the AIA PACK test cups The magnetic beads are washed to remove unbound enzyme labeled monoclonal antibody and are
37. on to SI units of IU L may be made using the following equations TU hCG L mIU hCG mL x 1 0 PERFORMANCE CHARACTERISTICS ACCURACY a l Recovery serum Three serum pools were spiked with three different levels of hCG and assayed before and after spiking Sample Initial hCG Expected Measured Percent Value Added Value Value Recovery mIU mL mIU mL mIU mL mIU mL Serum Al 0 00 76 97 76 97 66 56 86 5 0 00 153 94 153 94 136 01 88 4 0 00 307 88 307 88 274 50 89 2 Serum B1 0 00 76 97 76 97 68 78 89 4 0 00 153 94 153 94 136 30 88 5 0 00 307 88 307 88 285 22 92 6 Serum C1 4 14 76 97 81 11 76 26 94 0 4 14 153 94 158 08 155 40 98 3 4 14 307 88 312 02 298 69 95 7 a 2 Recovery urine Two urine e pools we were spiked with three different levels of hCG and assayed before and after spiking i Sample Initial hCG Expected Measured Percent Value Added Value Value Recovery mlU mL oe mIU mL mIU mL Urine A1 1 19 29 98 48 92 84 94 3 i sah 19 AE 195 78 193 79 99 0 1 19 389 17 390 36 379 76 97 3 Urine B1 1 26 97 29 98 56 99 52 101 0 1 26 194 59 195 85 182 15 93 0 1 26 389 17 390 43 376 07 96 3 b 1 Dilution serum Three serum samples containing high concentrations of hCG were serially diluted with AIA PACK HCG SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery mIU mL mIU mL Serum A2 none 358 21 7 5710 268 66 270 96 100 9 5 0 10 179
38. s HAMA Such specimens may show falsely elevated values when tested for human chorionic gonadotropin It has been reported 14 15 that hCG like substances can be sometimes found in blood of healthy adults especially of postmenopausal women and men of advanced age For a more complete understanding of the limitations of this procedure please refer to the SPECIMEN COLLECTION AND HANDLING WARNINGS AND PRECAUTIONS STORAGE AND STABILITY and PROCEDURAL NOTES sections in this insert sheet EXPECTED VALUES Each laboratory should determine a reference interval which corresponds to the characteristics of the population being tested As with all diagnostic procedures clinical results must be interpreted with regard to concomitant medications administered to the patient 13 Reference Ranges The interval given here was determined in serum and urine samples from apparently healthy Asian individuals mIU mL 1U L n Reference interval healthy men serum lt 0 5 137 healthy non pregnant women serum lt 0 5 24 urine lt 2 5 24 Expected hCG concentration During Pregnancy Gestational Age serum 4 7 weeks 612 187 000 36 8 11 weeks 17 700 315 000 28 12 20 weeks 5 400 169 000 25 21 40 weeks 3 440 69 700 89 urine 4 7 weeks 1 210 475 000 30 8 11 weeks 21 900 709 000 24 12 20 weeks 2 890 193 000 26 21 40 weeks 1 680 74 300 89 Conversion Factors HCG concentrations in this application are in units of mIU mL Conversi
39. soh com A Este produto cont m materiais de origem humana ou animal e deve ser tratado como potencialmente infeccioso POEAgUOTG kat Qa DEEL va dls ws OUVI tk amp Instructions For Use in multiple languages are available on our website www tosohbioscience eu under the Service amp Support section A paper version can be obtained by fax 32 13 66 47 49 or e mail info raqa eu tosoh com A This product contains human or animal source materials and should be treated as potentially infectious Las instrucciones de uso est n disponibles en diferentes idiomas en nuestra p gina web www tosohbioscience eu en la secci n de Service amp Support Servicio y Soporte Tambi n podemos enviarle una versi n impresa a trav s del fax 32 13 66 47 49 o por correo electr nico info raqa eu tosoh com A Este producto contiene tejidos de origen humano o animal ro Instructiuni de utilizare in diverse limbi sunt disponibile pe Vecjezicna navodila za uporabo so na voljo na na i spletni site ul nostru www tosohbioscience eu la sectiunea Service amp Support Service si asistenta tehnica O versiune pe hartie poate fi obtinuta comand nd o prin fax la 32 13 66 47 49 sau prin e mail la info raqa eu tosoh com Acest produs contine materiale de provenient uman sau animala si trebuie tratate ca potential infectioase strani www tosohbioscience eu v razdelku Service amp
40. specimens should be diluted by more than 5 fold with AIA PACK HCG SAMPLE DILUTING SOLUTION prior to analysis Either diluted or undiluted patient specimens are placed in appropriate positions on the TOSOH AIA System Analyzers For further information regarding sample preparation and instrument operation refer to the SPECIMEN COLLECTION AND HANDLING section and consult the specific TOSOH AIA System Operator s Manual respectively Barcoded primary tubes as well as sample cups can be run on AIA Nex IA AJA 21 ATA 600 II ATA 1800 AIA 2000 and AIA 360 B Assay Procedure 1 Ensure a sufficient quantity of ST AIA PACK HCG test cups for the number of samples to be run 2 Load patient samples as instructed in the Operator s Manual and proceed with analysis Note The AJA Nex IA AIA 21 AIA 600 I AIA 1800 and AIA 2000 will require AIA PACK SAMPLE TREATMENT CUPs if onboard dilutions are utilized PROCEDURAL NOTES 1 Lyophilized substrate must be completely dissolved 2 Ligand assays performed by the TOSOH AIA System Analyzers require that the laboratory use water designated by the College of American Pathologists as Class I or by NCCLS as Type I Water should be tested at least once per month and should be free of particulate matter including bacteria The pH of the water should also be routinely tested For further information consult the NCCLS document Preparation and Testing of Reagent Water in the Clinical Laboratory NCCLS Docum
41. there is a direct relationship between concentration and rate the rate should increase as the concentration increases 3 The replicate values should be within a 10 range D Calibration Review and Acceptance 1 Review the calibration curve carefully using the criteria listed above 2 Edit the calibration if necessary then accept the calibration For further information regarding calibration consult the TOSOH AIA System Operator s Manual Ill Quality Control Procedure A Commercially Available Controls Commercially available controls should be run at least once per day Itis recommended that at least two levels of controls normal and abnormal be used Laboratory policy for this particular assay designates the following Control Material Frequency Lot number of control material acceptable limits and corrective action to be taken if controls do not meet laboratory criteria will be found in a separate quality control document maintained by the laboratory P Quality Control Procedure Assay quality control specimens as instructed in the specific Operator s Manual for your analyzer In addition refer to the TOSOH AIA System Operator s Manual for detailed instructions on defining and editing the files 2 Quality contro material to be run with this assay is defined by individual laboratory policy IV Specimen Processing A Preparation Serum or heparinized plasma specimens do not requre dilution prior to analysis Urine
42. ukcijas vairiomis kalbomis galite rasti m s tinklalapio www tosohbioscience eu skyriuje Service amp Support Popierin versij galite gauti faksu 32 13 66 47 49 arba el pa tu info raqa eu tosoh com A iame gaminyje yra mogaus arba gyv n kilm s med iag tad elkit s taip tarsi jie gal t sukelti infekcij Lieto anas instrukcijas da d s valod s ir pieejamas m su interneta vietn www tosohbioscience eu sada Service amp Support Apkalpo ana un Atbalsts Druk tu versiju iesp jams sa emt pa faksu 32 13 66 47 49 vai e pastu info raga eu tosoh com is produkts satur cilv ku vai dz vnieku izejmaterialus un ir uzskat ms par potenci li infekciju saturo u g zakaz Instrukcja U ytkowania w r nych j zykach jest dost pna na naszej stronie internetowej www tosohbioscience eu w zak adce Service amp Support Serwis i Wsparcie O wersj papierow mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem info raqa eu tosoh com Produkt zawiera materia pochodzenia ludzkiego lub zwierz cego i dlatego nale y go traktowa jako potencjalnie ny pt As instruc es de utilizac o encontram se dispon veis em diversos idiomas no nosso sitio www tosohbioscience eu na seccao Service amp Support Servicos e Assist ncia Pode ainda obter uma vers o em papel atrav s do fax 32 13 66 47 49 ou do email info raqa eu to
43. will read gt 400 mIU mL On the recommended 5 fold dilution urine samples with hCG concentrations between 2 000 and 1 000 000 mIU mL will read gt 2 000 mIU mL The hook effect phenomenon may occur at hCG concentrations gt 200 000 mIU mL in serum or heparinized plasma and gt 1 000 000 mIU mL in urine 7 TOSOH ATA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST AIA PACK HCG assay STORAGE AND STABILITY All unopened materials are stable until the expiration date on the label when stored at the specified temperature Materials Cat No 2 8 C ST AIA PACK HCG 0025256 AIA PACK HCG CALIBRATOR SET 0020356 AIA PACK HCG SAMPLE DILUTING SOLUTION 0020556 ATA PACK SUBSTRATE SET II 0020968 AIA PACK WASH CONCENTRATE 0020955 AIA PACK DILUENT CONCENTRATE 0020956 1 30 C AIA PACK DETECTOR STANDARDIZATION TEST CUP 0020970 AIA PACK SAMPLE TREATMENT CUP 0020971 ST AIA PACK HCG test cups may be stored at 18 25 C for up to 1 day Calibrators and Sample Diluting Solution should be used within 1 day and 7 days of opening respectively provided the vials are kept tightly sealed and refrigerated at 2 8 C They should be used after equilibrating to 18 25 C for about 30 minutes The Sample Diluting Solution can be used for up to 90 days provided that 1 it is used with only ST AIA PACK HCG 2 it is used for manual dilutions ONLY and 3 the vials are kept tightly sealed and refrigerated immediately after use
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