試薬添付文書
Contents
1. 3 1 2 121 C 20 3 1 2 8 C 2 12 A Gh x 17 An E TOSOH TII 8 HCG 0015361 0015561 00159682. 90 90 4 5 6 E TOSOH II 8 HCG Wt v b EFA b TOSOH Il 8 HCG REAR E TOSOH TII SUB II E TOSOH II EFA b TOSOH II 7 hCG 8
3. HAMA Human Anti mouse Antibody 9 hCG hCG 6 7 2 1 HIV HBV HCV 2
4. 1 1 EFA TOSOH U 8 HCG 1 FU Rate 8 nmol L s 2 E TOSOH Il 8 HCG 1 B TOSOH II 8 HCG 2 FU hCG FU OL DE 0 2 1 5 nmol L s mIU mL FU FU A B C A 2 FU B 1 FU C 2 hCG 8 nmol L s nmol L s mIU mL 2 hCG 10 330 mIU mL 100 209 MATT B HCG E TOSOH I 8 HCG 3 hCG 8 10 330 mIU mL 2 10 15 4 0 5 400 mIU mL
5. B F 363 nm 447 nm hCG BB O O 90 400 mIU mL 1 5 kk AIA 1800 28 HCG 085 Y 4 B Calibrator
6. 390 mg dL 17 mg dL ET WAH 17 mg dL 1 600 mg dL 5 0 g dL 20 mg dL 100 U mL EDTA 2 8 C 15 25 C 1 1 2 3 4 5 6 E TOSOH Il 8 HCG au 15 25 C 1 2 8 C 7 E TOSOH Il 8 HCG 2 8 C 7
7. hCG BF 4 4 hCG 1 PRPC LTE He UA EAS Vy ee Ao TC HSV MEN Y Y BED M X IS VIREN TFT ZBI AM 2 8 C 20 C E TOSOH II 8 HCG
8. 15 25 C ST 2 8C 90 E TOSOH II 8 HCG 1 2 2 8 C 1 E TOSOH Il 8 HCG WHO hCG WHO 3rd IS 75 537 E TOSOH II 1 BE TOSOH I 1 100 mL 15 25C 3 H fal 2 8 C 7 E TOSOH II 1
9. TOSOH I 5 6 hCG 1 ALA 1200 AIA 600 10 2 hCG 8 1 EIA IEMA 3 HhCG 8 hCG 8 i 4 5 2 2 1 EIA IEMA HCH hCG 8
10. 0 5 mIU mL 1 2 1 FU y UH 2 x SD 10 200 000 mIU mL 5 hCG 100 hFSH 0 16 hLH N D hTSH N D X N D 6 y EIA x y 1 023 x 1 75 r 0 999 n 48 RB ARCOS YE y x y 0 970 x 0 149 r 1 000 n 152 1 1
11. 1 0 mL x2 E TOSOH II 8 HCG BATERIA 40mLAD x4 E TOSOH II E TOSOH II 100mL x2 100 mL x24 E TOSOH II 0015955 E TOSOH II 100 mL x44 0015956 E TOSOH I 100 mL x44 1 Hussa R O Biosynthesis of human chorionic gonadotropin Endocrine Rev 3 268 294 1980 2 Birken S Fetherston J Canfield R and Boime 1 The amino acid sequences of the peptide contained in the a and b subunits of human choriogonadotropin J Biol Chem 256 1816 1820 1981 3 Tojo S The biology and chemistry of placental peptide hormones and their clinical 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 structure between human chorionic gonadotropin present in urine of patients with trophoblastic diseases and healthy individuals
12. 2 5 L 15 25 C 30 E TOSOH I 1 5 15 25 C 30 2 gt 2 3 3 1 2 3 4 5 6 E TOSOH TII 8 HCG 100 50 u L 37 C 10
13. IU hCG 8 L mlU hCG 8 mL x 1 0 hCG human Chorionic Gonadotropin 3 ARRE 38 000 7 gw 8 hCG a hCG 2 c LH FSH TSH gw LH HhCG 3 hCG hCG hCG g 4 5 8 hCG hCG 8 hCG B hCG 8
14. 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 oku b Fri 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 raqa eu tosoh com IN 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 P 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 pouzitie vo viacerych jazykoch je dostupny na nasej web str nke www tosohbioscience eu v sekcii Service amp Support Vytlacen verziu mo no z ska faxom 32 13 66 47 49 alebo cez e mail info raqa eu tosoh com A Tento v robok obsahuje materi l z udsk ch alebo zvierac ch zdrojov a malo by sa s n m zaobch dza ako s potenci lne infek n m materi lom pos E Bruksanvisning p flera spr k finns att tillg p v r webbplats
15. 94 3 0 00 303 42 303 42 285 52 94 1 Serum Bi 0 00 75 85 75 85 73 17 96 5 0 00 151 71 151 71 148 62 98 0 0 00 303 42 303 42 293 95 96 9 Serum C1 341 75 85 79 26 80 20 101 2 3 41 151 71 155 12 155 94 100 5 3 41 303 42 306 82 309 27 100 8 b Dilution Three serum samples containing high concentrations of BHCG were serially diluted with AIA PACK BHCG SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery mIU mL mIU mL Serum A2 none 356 83 7 5 10 267 62 273 25 102 1 5 0 10 178 41 183 24 102 7 2 5 10 89 21 93 38 104 7 1 0 10 35 68 37 92 106 3 Serum B2 none 366 29 75 10 274 72 279 60 101 8 5 0710 183 15 190 81 104 2 2 5 10 91 57 96 50 105 4 1 0 10 36 63 38 97 106 4 Serum C2 none 380 37 7 5110 285 65 289 26 101 3 5 0 10 190 43 196 94 103 4 2 5 10 95 22 98 27 103 2 1 0 10 38 09 40 89 107 4 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 4 19 0 063 1 5 Serum B3 83 89 1 000 1 2 Serum C3 206 09 2 654 13 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 devi
16. Jpn J Cancer Res Gann 76 752 759 1985 6 Hartree A S Shownkeen R C Stevens V C et al Studies of the human chorionic 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 FT 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 Toson 2 ST AIA PACK BHCG Esponemckn norpe urern Evrop t z kazn ci Europ iske kunder Europ ische Kunden European customers Evpwnaior neAates Clientes europeos Euroopa kliendid Consommateurs europ ens Eur pai gyfelek Clienti europei Europos klientai Eiropas klienti Klienci europejscy Clientes europeus Clientii europeni Evropski kupci Eur pski
17. accordance with the strict regulatory agency under which the laboratory operates LIMITATIONS OF THE 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 BHCG the highest concentration of total beta hCG measurable in specimens without dilution is 400 mIU mL and the lowest measurable concentration in specimens is 0 5 mIU mL assay sensitivity 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 e Lipemia has an insignificant effect on the assay except in the case of gross lipemia where spatial interference may occur 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 antibodies HAMA Such specimens may show falsely elevated values when tested for total beta hCG 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 comple
18. number Part number E 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 Temperature limitation In vitro diagnostic medical device Consult instructions for use Ml Er g Authorized representative in the European Community Net volume after reconstitution for lyophilized material Manufacturer Use by date Supplied by Supplied by Q
19. 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 Ne produkt inneh ller material med humant eller animalt ursprung och skall behandlas som potentiellt infekti s 1007171001 039E 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 America favor de referirse a los documentos AIA AAM en Disco para la informaci n apropiada Aos clientes da America do Norte e America do Sul favor consultar os documentos do AIA AAM que est o em CD para informag 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 BHCG For Quantitative Measurement of human chorionic gonadotropin total beta hCG in Serum or Heparinized Plasma NAME AND INTENDED USE ST AIA PACK BHCG is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of human chorionic gonadotropin total beta hCG in human serum or heparinized plasma on TOSOH AIA 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 contains approximately 30 carbohydrate by weight 1 The alpha chains are virtually identi
20. 0 and 200 000 mIU mL will read gt 400 mIU mL The hook effect phenomenon may occur at BHCG concentrations gt 200 000 mIU mL 7 TOSOH AIA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST AIA PACK BHCG 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 BHCG 0025261 AJA PACK BHCG CALIBRATOR SET 0020361 AJA PACK BHCG SAMPLE DILUTING SOLUTION 0020561 AIA PACK SUBSTRATE SET II 0020968 AJA 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 BHCG 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 BHCG 2 it is used for manual dilutions ONLY and 3 the vials are kept tightly sealed and refrigerated immediately after use 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
21. 1007171001 039E 5 BHCG Immuno Enzymometric Assay DE TOSOH I 8HCG ST AIA PACK BHCG k4 1007171001 039E x 2009 3 5 2008 8 4 13A2X00174000005 A IREME REEERE LENY y t E TOSOH I 8HCG EIA hCG 1 2 hCG hCG 8 hCG 8 gt hCG 8 3 hCG 8 hCG 4 5 6
22. HBs HIV HCV 7 8 AILA 1200 AIA 600 1 EFA b TOSOH II 8 HCG hCG 8 Hi hCG 8 EFA b TOSOH II 8 HCG E TOSOH II 8 HCG 1 E TOSOH I 8 HCG 2 3 B TOSOH TII 8 HCG 4 BE TOSOH TII SUB II 1 E TOSOH II 4 2 E TOSOH Il EFA b TOSOH II E
23. Lot 2003506402080000 Rate 90 80 70 60 50 40 30 20 10 0 0 20 40 68 80 100 120 140 160 180 200 220 Conc i 1 1 2 3 E TOSOH TII 8 HCG hCG 8 a hCG 8 n mIU mL 137 lt 0 5 24 lt 0 5 4 7 36 590 187 000 8 11 28 17 800 328 000 12 20 25 5 380 183 000 21 40 89 3 460 71 500 2 x 3 8 2 1 2 SI hCG BEER mIU mL SI IU L
24. NT CONCENTRATE 0020956 SAMPLE CUPS 0018581 AIA PACK 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 ATA 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 ee AND PRECAUTIONS The ST AIA PACK BHCG is intended for in vitro diagnostic use only 5 Test cups from different lots or different assays should not be mixed within a tray 3 The ST AIA PACK BHCG 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 BHCG has been designed so that the high dose hook effect is not a problem for the vast majority of samples Samples with BHCG concentrations between 40
25. a AdBete thy Evronn popoh vrno aAAovras aitnon p ow pas otov optOgO 32 13 66 47 49 1 p co nAektpovicod taxvdpoueiov info raga eu tosoh com A To npoi v auto mepi xet vA k avdpwn vng 1 wik npo amp Aevong kat da np nsi va avtipetwniletat w dvvn tica koAvouart ko Lietosanas instrukcijas daz d s valod s ir pieejamas m su interneta vietne www tosohbioscience eu sadala Service amp Support Apkalpo ana un Atbalsts Druk tu versiju iesp jams sa emt pa faksu 32 13 66 47 49 vai e pastu N raqa eu tosoh com IN sis produkts satur cilveku vai dzivnieku izejmateri lus un ir uzskat ms par potenciali infekciju saturosu tad elkit s taip tarsi jie gal t sukelti infekcij 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 wersje papierowa mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem A raqa eu tosoh com IN Produkt zawiera materia pochodzenia ludzkiego lub araa i dlatego nale y go traktowa jako potencjalnie zaka ny As instru es de utiliza o encontram se disponiveis em diversos idiomas no nosso sitio www tosohbioscience eu na sec o Service amp Support Servi os 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 tosoh com Este produto cont m materiai
26. ation SD and coefficient of variation CV Sample Mean Pooled SD CV mIU mL mIU mL Serum A3 4 19 0 121 2 9 Serum B3 83 89 1 822 22 Serum C3 206 09 5 125 2 5 CORRELATION The correlation between serum x and heparinized plasma y on ST AIA PACK 2 was carried out using 152 patient specimens Slope 0 970 y Intercept 0 149 Correlation Coefficient 1 000 Range of Samples 0 5 378 4 Number of Samples 152 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as BHCG If these compounds are present in the specimen at the same concentration as BHCG the final result will be increased by these percentages Compound Cross reactivity hCG 100 hTSH N D hFSH 0 16 hLH N D N D not detectable SENSITIVITY The minimal detectable concentration MDC of total beta hCG is estimated to be 0 5 mIU mL The MDC is defined as the concentration of BHCG 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 and conjugated bilirubin up to 17 mg dL do not
27. be used if they appear cloudy or discolored SPECIMEN COLLECTION AND HANDLING Serum or heparinized plasma is required for the assay EDTA and citrated plasma SHOULD NOT BE USED 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 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 prior to testing Prior to assay bring frozen samples to18 25 C slowly and mix gently The sample required for analysis is 50 pL PROCEDURE For the AIA Nex IA AIA 21 AIA 600 II ATA 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 wo
28. cal 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 BHCG is a two site immunoenzymometric assay for the intact hCG molecule and beta subunit which is performed entirely in the AIA PACK test cups Intact hCG molecule and beta subunit present in the test sample are bound with monoclonal antibody immobilized on a magnetic solid phase and then a distinctly different antigenic site on the beta subunits is bound with enzyme labeled monoclonal antibody in the AIA PACK test cups The magnetic beads are
29. e of fluorescence produced by the reaction and automatically convert the rate to total beta hCG concentration in mIU mL For samples requiring dilution the AIA Nex IA AIA 21 AJA 600 I 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
30. east 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 Document C3 A3 Volume 11 No 13 originally approved as a guideline by NCCLS in October 1997 3 If a specimen total beta hCG concentration is found to be greater than the upper limit of the assay range 400 mIU mL the specimen should be diluted with the AIA PACK BHCG SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 400 mIU mL 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 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 BHCG 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 071 CALCULATION OF RESULTS The TOSOH AIA System Analyzers perform all sample and reagent handling operations automatically The TOSOH AIA System Analyzers read the rat
31. erial 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 B Quality Control Procedure 1 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 control material to be run with this assay is defined by individual laboratory policy IV Specimen Processing A Preparation Following specific instructions in the Operator s Manual for the analyzer place samples on the instrument appropriately Barcoded primary tubes as well as sample cups can be run on the AIA Nex IA AIA 21 AIA 600 II ALA 1800 ATA 2000 and ATA 360 ed Assay Procedure Ensure a sufficient quantity of ST AIA PACK BHCG 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 AIA NexIA AIA 21 ATA 600 II AIA 1800 and AIA 2000 will require AIA PACK SAMPLE TREATMENT CUPs if onboard dilutions are utilized PROCEDURAL NOTES Lyophilized substrate must be completely dissolved a 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 1 Water should be tested at l
32. interfere with the assay e 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 En Heparin up to 100 U mL does not interfere with the assay REFERENCES 1 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 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 J B ed W B Saunders Co Philadel
33. phia 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 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 human chorionic 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 Supplied by European Gonformity LOT Batch code Lot number Catalogue
34. 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 instrukcijas vairiomis kalbomis galite rasti m s tinklalapio www tosohbioscience eu skyriuje Service amp Support Popierine 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 Flersprogede brugsanvisninger findes p vores hjemmeside www tosohbioscience eu under Service amp Support sektionen Trykte brugsanvisninger kan rekvireres pr fax 32 13 66 47 49 eller e mail info raga eu tosoh com A Dette produkt indeholder menneskelige eller animalske Bedienungsanleitungen in verschiedenen Sprachen sind auf unserer Webseite www tosohbioscience eu Im Kapitel Service amp Support erh ltlich Ein Papierexemplar erhalten Sie auf schriftliche Anfrage an Faxnummer 32 13 66 47 49 oder per E Mail an info raqa eu tosoh com udgangsmaterialer og bor behandles som potentielt infektiost Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle Infektionsquelle behandelt werden O Oa Bpgtrg tic OSnyizc xpnons oe noits yA ooss otn dradirruak torroBecia uas www tosohbioscience eu otnv evotnta Service amp Support Mnopeite v
35. r calculating results 4B HOG 085 Y Ax B Calibrator Lot 2003506402080000 Rate 90 80 70 60 50 40 30 20 10 0 Q 20 40 60 80 100 120 140 160 180 200 220 Cone 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 BHCG 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 nmol L s 2 Since 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 lt is 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 mat
36. rking 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 AIA 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 to2 5L 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 BHCG have been standardized on WHO 3rd IS 75 537 The calibration curve for ST AIA PACK BHCG 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 of 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 fo
37. s de origem humana ou animal e deve ser tratado como potencialmente infeccioso EJ 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 IN Este producto contiene tejidos de origen humano o animal y debe ser tratado como producto potencialmente infeccioso amp Support Service si asistent tehnic O versiune pe h rtie poate fi obtinut comand nd o prin fax la 32 13 66 47 49 sau jh e mail la info raga eu tosoh com Mira produs con ine materiale de provenien uman sau Instructiuni de utilizare in diverse limbi sunt disponibile pe site ul nostru www tosohbioscience eu la sec iunea Service animal si trebuie tratate ca potential infectioase Veljezi na navodila za uporabo so na voljo na na i spletni strani www tosohbioscience eu v razdelku Service amp Support Servis in podpora
38. te 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 y 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 samples from apparently healthy Asian individuals mIU mL IU L n Reference interval healthy men serum lt 05 137 healthy non pregnant women serum lt 05 24 Expected total beta hCG concentration During Pregnancy Gestational Age serum 4 7 weeks 590 187 000 36 8 11 weeks 17 800 328 000 28 12 20 weeks 5 380 183 000 25 21 40 weeks 3 460 71 500 89 Conversion Factors Total beta hCG concentrations in this application are in units of mIU mL Conversion to SI units of IU L may be made using the following equation TU BHCG L mIU BHCG mL x 1 0 PERFORMANCE CHARACTERISTICS ACCURACY a Recovery Three serum pools were spiked with three different levels of BHCG and assayed before and after spiking Sample Initial BHCG Expected Measured Percent Value Added Value Value Recovery mIU mL mIU mL um mlU mL Serum Al 0 00 75 85 5 85 73 66 97 1 0 00 151 71 ee 143 02
39. washed to remove unbound enzyme labeled monoclonal antibody and are 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 BHCG concentration in the test sample A standard curve is constructed au unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK BHCG Cat No 0025261 Plastic test cups containing lyophilized twelve magnetic beads coated with anti hCG mouse monoclonal antibody and 100 pL of mouse monoclonal antibody to hCG B 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 total beta hCG analysis using the ST AIA PACK BHCG Cat No 0025261 on the TOSOH AIA System Analyzers They are available separately from TOSOH Materials Cat No AIA Nex IA or AIA 21 0018539 AJA Nex IA or AJA 21 LA 0018540 AIA 1800 ST 0019836 AIA 1800 LA 0019837 AIA 2000 ST 0022100 AIA 2000 LA 0022101 AIA 600 II 0019014 AIA 600 II BCR 0019328 AIA 360 0019945 AIA PACK SUBSTRATE SET II 0020968 AJA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK BHCG CALIBRATOR SET 0020361 ZERO CALIBRATOR 0 mIU mL POSITIVE CALIBRATOR 200 mIU mL approx AIA PACK BHCG SAMPLE DILUTING SOLUTION 0020561 AIA PACK WASH CONCENTRATE 0020955 AJA PACK DILUE
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