試薬添付文書
Contents
1. B F 4 4 EDTA ME ROA Y AY YBEMA ED 1 EDTA 2 8 C 20 C 22. 5 5 6 E TOSOH Il IRI E TOSOH I IRI ARM EFA bk TOSOH II SUB HI E TOSOH HH E TOSOH I 7 EDTA ER HT S HAMA Human Anti mouse Antibody
3. 121 C 20 3 1 2 8C 2 12745 i A E TOSOH U IRI 0025260 1 1 0mL x2 2 6 1 0 mL x2 E TOSOH II IRI 0015360 E TOSOH II IRI E TOSOH Il E TOSOH Il 100mL x24 0015968 E TOSOH II 100 mL x24 0015955 E TOSOH II 100 mL x44 0015956 E TOSOH II 100 mL x44 1 44 136 143 1986 2 C
4. 9 8 2 1 HIV HBV HCV 2 3 1 2
5. 63 152 163 1980 3 31 1636 1644 1973 4 1 17 33 1967 5 Mook No 18 70 88 1984 252 1123 2743 1 0120 17 1200 TEL 0467 76 5384 FAX 0467 79 2550 O TosoH 3 8 2 TEL 03 5427 5181 FAX 03 5427 5220 TosoH 2 ST AIA PACK IRI Vee EBpone cku norpe ntenu Evrop t z kazn ci gt Europ iske kunder Europ ische Kunden E European customers Eupwnaio neA teg 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 zakaznici Euro
6. HHRI O71 Y AC HRs Ck FD Galibrator Lot 2005505606070000 Rate 0 q0 200 0a Gone 1 1 E TOSOH II IRI 2 3 200 1 1 17 0 a U mL 2 3 2 1 2 SI ur U mL SI mU L mU L gu mL x 1 0 Insulin tt EMOS YP VAY ARB BME ODMSNS 51
7. 3 E TOSOH Il IRI 17 mg dL 18 mg dL 1 600 mg dL 5 0 g dL 20 mg dL 100 U mL EDTA 10 mg mL 1 x 5 5 6 2 8C 15 25 C 1 1 E
8. 5 E TOSOH II 1 2 5 15 25 C 30 6 E TOSOH II 1 5L 15 25 C 30 2 2 3 1 TOSOH I IRI IESO MBA y TOP VEY r i 2 100 u L 50 x L 37
9. TOSOH I IRI 15 25 C 1 2 8 C 7 2 E TOSOH Il IRI 2 8 C 7 3 E TOSOH Il IRI 1 E TOSOH II IRI m 2 6 1 0 mL 2 SCHE 1 E TOSOH II IRI WHO IRI WHO 1st IRP 66 304 4 HAR E FAZ h TOSOH II UAKETFX b TOSOH II 1 100 mL 15 25 C 3 il 2 8 C 7
10. 5 700 A 21 BM 30 2 S S A 1 S S 1 2 5 1 1 1 E TOSOH Il IRI 1 FUL Rate 8 nmol L s 2 E TOSOH H IRI Mah 1 B TOSOH II IRI 6 FU FU olk GE amp 0 2 1 8 nmol L s u U mL FU FU A B C A 6 FU nmol L s B 1 O FU nm
11. AIA 1200 AIA 600 1 BE TOSOH I IRI 2 B TOSOH Il IRI E TOSOH I IRI 1 E TOSOH H IRI 2 E TOSOH U IRI 3 E TOSOH I IRI 4 E TOSOH II IRI 5 E TOSOH II IRI 6 BE TOSOH Il IRI 4 E TOSOH II SUB II 1 E TOSOH II 4 2 E TOSOH I 5 BE TOSOH TII 6 EFA b TOSOH Il w IRD 1 1
12. Serum Al 8 97 259 1 268 1 264 1 98 5 8 97 129 6 138 5 142 7 103 0 8 97 64 8 73 7 72 6 98 5 Serum Bl 7 67 259 1 266 8 260 1 97 5 7 67 129 6 137 2 138 4 100 9 7 67 64 8 72 4 71 6 98 9 Serum Cl 10 4 259 1 269 5 264 4 98 1 10 4 129 6 140 0 141 7 101 3 10 4 64 8 75 2 76 1 101 2 b Dilution Three serum samples containing high concentrations of insulin were serially diluted with AIA PACK IRI SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery uU mL uU mL Serum A2 none 226 8 7 5 10 170 1 173 4 101 9 5 0 10 113 4 116 7 102 9 2 5 10 56 7 56 7 100 0 1 0 10 22 7 21 0 92 4 Serum B2 none 265 2 7 5 10 198 9 207 2 104 2 5 0 10 132 6 143 2 108 0 2 5 10 66 3 70 4 106 2 1 0 10 26 5 25 1 94 6 Serum C2 none 290 9 7 5110 218 2 226 2 103 7 5 0 10 145 5 156 0 107 3 2 5 10 72 7 75 9 104 3 1 0 10 29 1 27 6 94 9 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 uU mL uU mL Serum A3 12 3 0 277 2 3 Serum B3 92 2 1 324 1 4 Serum C3 164 4 2 436 1 5 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 poole
13. 1 INTERFERENCE Interference is defined for the purposes of this study as recovery outside of 10 of the known mean concentration of the specimen after the following substances are added to human specimens Free bilirubin up to 17 mg dL and 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 e Protein as indicated by human albumin concentration up to 5 0 g dL does not interfere with the assay Heparin up to 100 U mL does not interfere with the assay EDTA up to 10 mg mL does not interfere with the assay e Hemoglobin could interfere with the assay particularly at low range Hemolyzed samples should not be used for the ST AIA PACK IRI assay because hemolysis may falsely bring down the value due to insulin degrading enzyme in red blood cells REFERENCES 1 Wrenshall G A et al The Story of Insulin Indiana University Press Bloomington 1962 2 Lavy P L The Pancreatic Beta Cell Structure and Function New Eng J Med 276 187 1967 Steiner D F Proinsulin and the Biosynthesis of Insulin New Eng J Med 283 522 1970 Levine R Mechanisms of Insulin Secretion New Eng J Med 283 522 1970 Rieser P Insulin Membranes and Metabolism Williams and Wilkins Baltimore 1967 Ashmore J
14. AIA 1200 AIA 600 10 2 1 BIA IEMA 3 4 5 2 2 1 EIA IEMA
15. 66 47 49 ali elektronski po ti info raqa eu tosoh com Ta izdelek vsebuje materiale loveskega ali Zivalskega izvora kar lahko privede do okuzb et Eri keeltes kasutusjuhendid on saadaval meie veebilehel www tosohbioscience eu alajaotuses Service amp Support Paberkandjal versiooni saab tellida faksinumbril 32 13 66 47 49 voi e posti teel info raqa eu tosoh com A See toode sisaldab inim v i loomse p ritoluga aineid ning voib olla nakkusohtlik am 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 E 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 v robok obsahuje material 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 Bruksanvisning p flera spr k finns att tillg p v r webbplats www tosohbioscience eu under rubriken Service amp Suppo
16. II AIA PACK IRI CALIBRATOR SET 0020360 CALIBRATOR 1 0 HU mL CALIBRATOR 2 20 HU mL approx CALIBRATOR 3 40 HU mL approx CALIBRATOR 4 80 HU mL approx CALIBRATOR 5 160 HU mL approx CALIBRATOR 6 340 HU mL approx ATA PACK IRI SAMPLE DILUTING SOLUTION 0020560 AIA PACK WASH CONCENTRATE 0020955 ATA PACK DILUENT CONCENTRATE 0020956 SAMPLE CUPS 0018581 AJA 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 Den AND PRECAUTIONS The ST AIA PACK IRI is intended for in vitro diagnostic use only Test cups from different lots or different assays should not be mixed within a tray 3 The ST AIA PACK IRI 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 d
17. sample calibration curve from AIA 1800 follows and shows the algorithm used for calculating results BIRD Calibrator Lot 2005505606070000 Ts AB Or D 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 CALIBRATOR 1 for ST AIA PACK IRI is provided ready for use TOSOH recommends that all calibrators should be run in triplicate 4 CALIBRATOR 2 6 for ST AIA PACK IRI are lyophilized All levels should be reconstituted with 1 0 mL of CAP Class I or NCCLS Type I Reagent Grade water TOSOH recommends that all calibrators should be run in triplicate C Calibration Acceptability Criteria 1 The mean rate for the CALIBRATOR 1 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 IH Quality Control Procedure A Commercially Available Controls Commercially available controls should be run at least on
18. 100587 1001 059D 4 IRI Immuno Enzymometric Assay E TOSOH U IRI ST AIA PACK IRI k4 20094 5 4 2006 10 3 13A2X00174000010 1005871001 059D A OE TOSOH II IRI EIA EDTA MERO RD 1 Ait 2 3 4 HBs HIV HCV 5 6
19. 32 13 66 47 49 n u co nAektpovikod taxvdpoueiov info raqa eu tosoh com A To npo v avt nepi xer viik avOparnivys 1 wig nmpo Aevons kat da np ret va avtipetonileta w SvvyntiKa HoAvopatuco Oa Bpeire lc Odnyies xpnons oe noi s yAWOoES OTN Siaductvaxi 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 raqa eu tosoh com is produkts satur cilv ku vai dz vnieku izejmateri lus un ir uzskat ms par potenci li infekciju saturo u 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 papierow mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem info raqa eu tosoh com Produkt zawiera material pochodzenia ludzkiego lub zwierzecego i dlatego nalezy go traktowac jako potencjalnie zaka ny pt As instru es de utiliza o encontram se dispon veis 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 A Este produto cont m materiais de origem humana ou animal e deve ser tratado co
20. 954 x 0 165 r 0 997 n 47 FETAY VE y x y 0 975 x 0 704 r 0 999 n 91 AVEC EDTA mae y 0 VIE x s y 0 991 x 0 719 r 0 998 n 60 1 1 90 90 4
21. C 10 3 B F 4 363 nm 447 nm O 90 6 320 u U mL 1 5 ee AIA 1800
22. Weber G Hormonal Control of Carbohydrate Metabolism in Liver in Carbohydrate Metabolism and its Disorders ed Dickens Randle and Wholan Academic Press London New York 1968 7 Samols E Immunological Aspect of Insulin on the Nature and Treatment of Diabetes Mellitus ed Leibel Wrenshall Excepta Medica Foundation Amsterdam 1965 8 Fajans S S Conn J W The Early Recognition of Diabetes Mellitus Ann N Y Acad Sci 82 208 1959 9 Cerasi E Luft R Plasma Insulin Response to Glucose Infusion in Healthy Subjects and in Diabetes Mellitus Acta Endocr kbh 55 278 304 1967 10 Cerasi E et al Decreased Sensitivity of the Pancreatic beta Cells to Glucose in Prediabetic and Diabetic Subjects Diabetes 21 224 234 1972 11 Young D Effects of Drugs on Clinical Laboratory Tests 3rd Edition Washington DC American Association for Clinical Chemistry Press 1990 NR TOSOH CORPORATION Shiba koen First Bldg 8 8 2 Shiba Minato ku Tokyo 105 8623 Japan Phone 81 3 5427 5181 Fax 81 3 5427 5220 TOSOH EUROPE N V EC REP Transportstraat 4 B 3980 Tessenderlo Belgium Phone 32 13 66 88 30 Fax 32 13 66 47 49 A TOSOH BIOSCIENCE INC Supplied by 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 i of European Conformity In vitro diagnostic medical device Consult instruction
23. a e mail a info raqa eu tosoh com A Il prodotto contiene materiali di origine umana o animale e va trattato come potenzialmente infettivo a Naudojimo instrukcijas jvairiomis kalbomis galite rasti m sy tinklalapio www tosohbioscience eu skyriuje Service amp Support Popierine versija 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 da 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 raqa eu tosoh com A Dette produkt indeholder menneskelige eller animalske udgangsmaterialer og bor behandles som potentielt infektiost de 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 Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle Infektionsquelle behandelt werden torroBecia pac www tosohbioscience eu otnv ev rnta Service amp Support Mropeite va Ad ete tnv vtury popoh vroB lMovras aitnon LEO pag otrov api0u
24. atients 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 insulin Specimens in the presence of autoantibody to insulin may show discrepant results 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 11 Reference Ranges The interval given here was determined in serum samples from 200 apparently healthy Asian individuals Reference Interval 1 1 17 0 U mL 1 1 17 0 mU L Conversion Factors Insulin concentrations in this application are in units of U mL Conversion to SI units of mU L may be made using the following equation mU insulin L U insulin mL x 1 0 PERFORMANCE CHARACTERISTICS ACCURACY a Recovery Three serum pools were spiked with three different levels of insulin and assayed before and after spiking Sample Initial Insulin Expected Measured Percent Value Added Value Value Recovery uU mL U ml YU mL U mL
25. ble 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 EDTA plasma is required for the assay Citrated plasma SHOULD NOT BE USED 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 or EDTA 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 to 18 25 C slowly and mix gently The sample required for analysis is 50 pL PROCEDURE For the AIA NexIA 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 Subs
26. ce per day It 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 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 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 AIA 1800 AIA 2000 and AIA 360 B Assay Procedure 1 Ensure a sufficient quantity of ST AIA PACK IRI 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 Nex IA AIA 21 AIA 600 II AIA 1800 and AIA 2000 will require AIA PACK SAMPLE TREATMENT CUPs if onboard dilutions are utilized PROCEDURAL NOTES 1 Lyophilized substrate must be comp
27. d standard deviation SD and coefficient of variation CV Sample Mean Pooled SD CV uU mL uU mL Serum A3 12 3 0 559 4 6 Serum B3 92 2 2 425 2 6 Serum C3 164 4 4 669 2 8 CORRELATION The correlation between serum x and heparinized plasma y on ST AIA PACK IRI was carried out using 91 patient specimens Slope 0 975 y Intercept 0 704 Correlation Coefficient 0 999 Range of Samples 1 2 281 9 Number of Samples 91 The correlation between heparinized plasma x and EDTA plasma y on ST AIA PACK IRI was carried out using 60 patient specimens Slope 0 991 y Intercept 0 719 Correlation Coefficient 0 998 Range of Samples 1 4 240 7 Number of Samples 60 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as insulin If these compounds are present in the specimen at the same concentration as insulin the final result will be increased by these percentages Compound Cross reactivity Bovine insulin 72 Porcine insulin 100 Ovine insulin 75 Human C peptide N D Human proinsulin 2 N D not detectable SENSITIVITY The minimal detectable concentration MDC of insulin is estimated to be 0 5 JU mL The MDC is defined as the concentration of insulin which corresponds to the rate of fluorescence that is two standard deviations from the mean rate of fluorescence of 20 replicate determinations of a CALIBRATOR
28. ecifications must be entered under test code 058 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 insulin concentration in U mL For samples requiring dilution the AIA Nex IA AIA 21 AIA 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 AIA System Analyzers If one or more co
29. erived from human serum please use standard laboratory safety procedures in handling all specimens and controls Do not use beyond the expiration date The ST AIA PACK IRI has been designed so that the high dose hook effect is not a problem for the vast majority of samples Samples with insulin concentrations between 320 and 20 000 U mL will read gt 320 U mL The hook effect phenomenon may occur at insulin concentrations gt 20 000 U mL 7 TOSOH AIA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST AIA PACK IRI assay anu 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 IRI 0025260 AIA PACK IRI CALIBRATOR SET 0020360 AIA PACK IRI SAMPLE DILUTING SOLUTION 0020560 AIA 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 IRI test cups may be stored at 18 25 C for up to 1 day Calibrators and Sample Diluting Solution should be used within day and 7 days of opening or reconstituting respectively provided the vials are kept tightly sealed and refrigerated at 2 8 C 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 sta
30. letely 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 Document C3 A3 Volume 11 No 13 originally approved as a guideline by NCCLS in October 1997 3 If a specimen insulin concentration is found to be greater than the upper limit of the assay range 320 wU mL the specimen should be diluted with the AIA PACK IRI SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 320 wU mL is 1 10 or 1 100 It is desirable to dilute the specimen so that the diluted specimen reads between 10 and 300 wU 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 IRI 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 sp
31. mo potencialmente infeccioso en 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 IN This product contains human or animal source materials and should be treated as potentially infectious es 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 raga eu tosoh com IN Este producto contiene tejidos de origen humano o animal y debe ser tratado como producto potencialmente infeccioso Instructiuni de utilizare in diverse limbi sunt disponibile pe site ul nostru www tosohbioscience eu la sectiunea Service 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 prin e mail la info raqa eu tosoh com Acest produs contine materiale de provenient umana sau animala 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 V papirni obliki jih lahko prejmete po faksu 32 13
32. ntrol 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 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 IRI the highest measurable concentration of insulin in specimens without dilution is 320 U mL and the lowest measurable concentration in specimens is 0 5 HU mL assay sensitivity Although the approximate value of the highest calibrator is 340 U mL the exact concentration may be slightly different The assay specification ASSAY RANGE HIGH should be defined as the upper limit of the assay range 320 4U mL Hemolyzed samples should not be used for the ST AIA PACK IRI assay because hemolysis may falsely bring down the value due to insulin degrading enzyme in red blood cells 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 Samples containing fibrin may exhibit either falsely elevated or falsely decreased results Specimens from p
33. ol L s C 6 u U mL 2 10 260 u U mL 100 20 IRI E TOSOH I IRI 3 10 260 u U mL 3 10 15 4 0 5 gt 320 u U mL 0 5 u U mL 1 10 FU 2 x SD 20 000 u U mL 5 72 100 75 C N D 2 N D 6 y EIA x y 0
34. peiska kunder bg MucTrpykuun 3a ynorpe a Ha pas nmyuHu esuum ca Ha pasnono gt kenune Ha namna ye ca t www tosohbioscience eu B paspena IIomo n noxap oka Service amp Support XaprneHo Komme Moxe a Obre Noy4eHo Ha fax 32 13 66 47 49 nmu e mail info raqa eu tosoh com Tosu npoxyKT Cp BD2Ka MaTepuann YOBeMIKM MAK XUBOTUHCKA NPOU3XOA U TPA BA Ja b TPeTUpaH KATO TOTEHLMAIHO LHDeKTLYTO3eTH Navod k pouZiti v r znych jazycich je dostupny na nasich webov ch str nk ch www tosohbioscience eu v sekci Service amp Support Ti t nou 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 lidi a je t eba s nimi zach zet jako s potenci ln infek n mi ce A Haszn lati utasit s t bb nyelven el rhet websz jtunkon www tosohbioscience eu a Service amp Support Szolgaltat 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 raga eu tosoh com A Ez a term k emberi vagy llati forr sanyagokat tartalmaz ez rt lehets gesen fert z k nt kell kezelni it Istruzioni per P 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 vi
35. resent 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 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 insulin concentration in the test sample A standard curve is constructed and unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK IRI Cat No 0025260 Plastic test cups containing lyophilized eight magnetic beads coated with anti insulin mouse monoclonal antibody and 100 pL of anti insulin mouse monoclonal antibody to human insulin 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 insulin analysis using the ST AIA PACK IRI Cat No 0025260 on the TOSOH AIA Systems Analyzers They are available separately from TOSOH Materials Cat No AIA Nex IA or AIA 21 0018539 AIA Nex IA or AIA 21 LA 0018540 AIA 1800 ST 0019836 ATA 1800 LA 0019837 AIA 2000 ST 0022100 AIA 2000 LA 0022101 AIA 600 II 0019014 ATA 600 II BCR 0019328 AJA 360 0019945 AIA PACK SUBSTRATE SET II 0020968 AIA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT
36. rt En pappersversion kan erh llas per fax 32 13 66 47 49 eller e post info raqa eu tosoh com A Denna produkt inneh ller material med humant eller animalt ursprung och skall behandlas som potentiellt infekti s 1005871001 059D Rev 05 09 Attention For North and South American Customers Please refer to the ATA 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 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 IRI For Quantitative Measurement of insulin IRI in Serum Heparinized Plasma or EDTA Plasma NAME AND INTENDED USE ST AIA PACK IRI is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of insulin IRI in human serum heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers SUMMARY AND EXPLANATION OF TEST Insulin the antidiabetic hormone is produced in the pancreatic B cell as a large preproinsulin containing 109 amino acid residues with a molecular weight of approximately 11 500 1 2 This peptide is rapidly converted by cleavage to proinsulin consisting of 86 amino acid residues with a molecular
37. s for use Temperature limitation LOT WM foe 5 Authorized representative in the European Community Supplied by NET Catalogue number Supplied by Net volume Part number after reconstitution for lyophilized material Batch code Lot number Manufacturer Use by date
38. trate 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 and 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 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 IRI have been standardized on WHO 1st IRP 66 304 1974 The calibration curve for ST AIA PACK IRI 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
39. weight of approximately 9 000 and is stored within the B cell secretory granules 3 Equimolar quantities of insulin 51 amino acids with a molecular weight of approximately 6 000 and C peptide 31 amino acids molecular weight of approximately 3 000 are produced through proteolytic cleavage and then secreted along with a small amount of proinsulin 4 Insulin exists in polymeric forms depending on the pH and zinc content The monometric insulin molecule is composed of two polypeptide chains alpha and beta which are connected by two interchain disulfide bridges of cystine 3 l Insulin is degraded in most tissues and has a plasma half life of 7 15 minutes in man Itis also rapidly and completely inactivated in the gastrointestinal tract Daily production of insulin in a healthy adult is 40 50 units After binding to its specific receptors on target cell membranes insulin acts as an anabolic and anticatabolic hormone influencing the rates of carbohydrate lipid protein and electrolyte metabolism 5 7 Insulin release is stimulated by glucose A failure to respond to this glucose stimulus may be one of the fundamental defects in human diabetes 8 10 The factors stimulating or inhibiting insulin release or the factors decreasing the tissue response to insulin have been well documented PRINCIPLE OF THE ASSAY The ST AJA PACK IRI is a two site immunoenzymometric assay which is performed entirely in the AIA PACK test cups Insulin p
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