試薬添付文書
Contents
1. B F 4 4 C 1 EDTA MIF MISES DMS SBA seek 2 8 C 20 C 2 3 E TOSOH II C 4 5 102. 2 3 1 E TOSOH II C 2 100 L EDTA E TOSOH II C 10 20 37 C 10 3 B e F 4 363 nm
3. 1 EFA b TOSOH I C C C 2 E TOSOH II C E TOSOH U C 1 E TOSOH Il C 2 E TOSOH II C 3 E TOSOH II C 4 EFA b TOSOH H C 5 E TOSOH II C 6 E TOSOH II C BRIAR 4 E TOSOH II SUB I 1 BE TOSOH II 4 2 E TOSOH Il 5 E TOSOH I 6 E TOSOH II wo C CPR 1 xkl
4. 2 8 C 20 C 410 mg dL 16 mg dL ET AH 17 mg dL 1 600 mg dL 5 0 g dL 20 mg dL 100 U mL EDTA 10 mg mL 7 8 2 8 C 15 25 C 43 1 E TOSOH Il C 15
5. 1 2 8C 2 12 n E TOSOH Il C 0025284 100 D H 1 E TOSOH II C 1 0 mL x2 2 6 1 0 mL x2 0015384 EFA t TOSOH I C PRA ASA E TOSOH I 0015968 E TOSOH II 100 mL x2 BE TOSOH II 100 mL x2 0015955 E TOSOH II 100 mL x4 0015956 E TOSOH II 100 mL x44 l Steiner D F and Oyer P E The biosynthesis of insulin and a probable precursor of insulin by a human islet cell adenoma Proc Natl Acad Sci USA 57 473 480 1967 2 Steiner D F et al Insulin biosynthesis Evidence for a precursor Science 157 697 700 1967 3 Kajinuma H et al Human plasma C peptide immunoreactivity its correlation with immunoreactive insulin in diabetes and chroni
6. 10 2 C 1 EIA IEMA 3 C C 4 5 2 2 1 EIA IEMA C C
7. 6 7 E TOSOH II C EFA t TOSOH II C E TOSOH TII SUB II E TOSOH TII EFA t TOSOH II DER 8 AMI ME XBRFOC 3 74 PHIM CTOC WEI ERA EDTA 118 9 HAMA Human Anti mouse Antibody 2
8. 2 8 C 1 E TOSOH II C WHO C WHO Ist IRP 84 510 4 E TOSOH II 1 E TOSOH Ul 1 100 mL 15 25 C 3 2 lt 8 C 7 5 E TOSOH II 1 2 5 L 15 25 CKiE C 30 6 E TOSOH II 1 5L 15 25 C 30 2 1
9. TOSOH 3 8 2 TEL 03 5427 5181 FAX 03 5427 5220 ie ore all Tosoh 2 ST AIA PACK C Peptide EBpone cka norpe urean Evrop t z kazn ci Europ iske kunder Europ ische Kunden European customers Evpwraiot rehares 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 z kazn ci Europeiska kunder Mactpykymm 3a ynotpe6a Ha pasImuHH esnia ca Ha DASITO7LO2KHG Ha Hama ye ca r www tosohbioscience eu B pasmena Tlomony n no pbxka Service amp Support Xaprneno komme Moxe ga 6pze nony4eHo Ha fax 32 13 66 47 49 min e mail info raqga eu tosoh com Axryaxma Bepcus CPEP 010311 A Tosu HpOgyKT Chybp Ka MATEpHAIN C YOBEUIKM WIN KMBOTHHCKM NpON3XOJ N TpA BA Ha ObAe TPETUPAH KATO OTEHIMANHO nudekyMosen CE EU rev CPEP 010311 Ma Haszn lati utas t s 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 Aktu lis V ltozat CPEP 010311
10. Lg C NA7FF L ng C mL x 1 0 CC 7 2 1 1 C 1 C C B 4 5 C
11. 6 7 89 1 1 E TOSOH IT C 1 FU Rate 4 nmol L s 2 EFA b TOSOH Il C 1 E TOSOH II C A7F F 2 FU C FU OH 0 6 nmol Ls ng mL YE FU FU A B C A 2 FU nmol L s B 1 FU nmol L s C 2 C ng mL 2 100 20 C TOSOH Il C 3 10 15
12. y 0 972 x 0 085 r 0 996 n 50 1 1 2 3 4 90 90 5
13. 1 HIV HBV HCV 2 3 1 2 121 C 20 3
14. 4 0 2 30 ng mL 2 0 300 ng mL 10 0 2 30 ng mL 0 2 ng mL 2 0 ng mL 1 10 FU 2 x SD 90 ng mL 900 ng mL 90 ng mL OR k 5 AEN BUDE C 100 31 5 N D N D 6 y EIA x y 1 054 x 0 244 r 0 998 n 55 y 1 108 x 0 381 r 0 998 n 49 RETOS YE y x y 0 978 x 0 015 r 0 997 n 50 EDTA HE y x OMR L MRL O
15. 447 nm C O O 90 O 30 ng mL 300 ng mL 1 5 x5 6 AIA 1800 10 1 10 OPep 047 Calibrator Lot 2005604306080000 Yade a YE t CM d Rate 300 1 1 2 3 EFA b TO
16. O versiune pe h rtie poate fi ob inut comand nd o prin fax la 32 13 66 47 49 sau prin e mail la info raqa eu tosoh com Versiune Actual CPEP 010311 A Acest produs contine materiale de provenient uman sau animal si trebuie tratate ca potential infec ioase Vecjezicna 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 66 47 49 ali elektronski po ti info raqa eu tosoh com Aktualna Razli ica CPEP 010311 A Ta izdelek vsebuje materiale love kega ali ivalskega izvora kar lahko privede do oku b 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 Aktu lna Verzia CPEP 010311 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 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 Aktuell Version CPEP 010311 A Denna produkt inneh ller material med humant eller ani
17. A Produkt zawiera material pochodzenia ludzkiego lub zwierzecego i dlatego nale y go traktowa jako potencjalnie zaka ny g Oa peite lc OSryies xprons oe noi s yAWooES otn StadiKTVaKI tono8ecia pac www tosohbioscience eu otnv Evo no Service amp Support Mnopeite va AdBete tn v vtvny popoh vro iiovtag aitnon Leow Pag otov apidu 32 13 66 47 49 y p ow nAekTpovikod taxv pougiov info raqa eu tosoh com Tp xovoa Exdoon CPEP 010311 A To potOv avt nepi yer VALKO av pwnivns wiks npo ievong kat Oa np ne va avriperoriferal wo VVNTIKA poAvapatiKo E 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 Vers o Actual CPEP 010311 N Este produto cont m materiais de origem humana ou animal e deve ser tratado como 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 Actual Version CPEP 010311 A This product contains human or animal source materials and should be treated as potentially infectious Las instrucciones de us
18. 800 685 7595 A A European Conformity In vitro diagnostic medical device Consult instructions for use Temperature limitation LOT IEclREp Authorized representative in the European Community Supplied by N Catalogue number Supplied by Sufficient for 1 Part number Batch code Lot number Manufacturer Use by date
19. 25 C 240 1 15 25 Cic 8 2 8 C 16 30 2 8 C 30 2 E TOSOH Il C 8 C 7 2 8 C 90 E TOSOH I C 1 E TOSOH I C 2 6 1 0 mL
20. AIA PACK C Peptide was carried out using 50 patient specimens Slope 0 972 y Intercept 0 085 Correlation Coefficient 0 996 Range of Samples 10 114 Number of Samples 50 PRECISION a Within run precision was determined using six controls in a total of 20 runs Within each tun 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 ng mL ng mL Serum A3 4 67 0 0843 18 Serum B3 8 88 0 1341 15 Serum C3 18 06 0 2623 15 Heparinized plasma A3 8 88 0 1288 15 EDTA plasma A3 10 22 0 1472 14 Urine A3 2 23 0 0393 1 8 b Total precision was determined by the duplicate assay of six controls in 20 separate runs The means of each run were used to calculate the pooled standard deviation SD and coefficient of variation CV Sample Mean Pooled SD CV ng mL ng mL Serum A3 4 67 0 1401 3 0 Serum B3 8 88 0 2617 3 0 Serum C3 18 06 0 5004 28 Heparinized plasma A3 8 88 0 2149 2 4 EDTA plasma A3 10 22 0 2431 24 Urine A3 2 23 0 0739 33 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as C peptide If these compounds are present in the specimen at the same concentration as C peptide the final result will be increased by these percentages Compound Cross reactivi
21. C peptide levels are to be expected Elevated C peptide levels may result from increased B cell activity associated with insulinomas 4 6 Anti insulin antibodies are commonly found in patients who have undergone insulin therapy These circulating anti insulin antibodies may interfere with certain immunoassays for insulin making it difficult to use as a measure of residual B cell activity C peptide measurement is therefore used as an alternative measurement index in this context 7 C peptide measurement is also used as an additional means of evaluating glucose tolerance tests 8 PRINCIPLE OF THE ASSAY The ST AIA PACK C Peptide is a two site immunoenzymometric assay which is performed entirely in the ST AIA PACK C Peptide test cups C peptide present in the test sample is bound with antibody immobilized on a magnetic solid phase and enzyme labeled monoclonal antibody in the 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 C peptide concentration in the test sample A standard curve is constructed and unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK C Peptide Cat No 0025284 Plastic test cups containing lyophilized twelve magnetic beads with anti C peptide r
22. gt 30 ng mL On the recommended 10 fold dilution urine samples with C peptide concentrations between 300 and 900 ng mL will read gt 300 ng mL The hook effect phenomenon may occur at C peptide concentrations gt 90 ng mL in serum heparinized plasma or EDTA plasma and gt 900 ng mL in urine 8 For safe waste disposal it is recommended that each laboratory complies with established laboratory procedures and local state and federal regulations 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 AJA PACK C Peptide 0025284 AIA PACK C Peptide CALIBRATOR SET 0020384 AIA PACK C Peptide SAMPLE DILUTING SOLUTION 0020584 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 ATA PACK SAMPLE TREATMENT CUP 0020971 After opening the aluminum pouch ST AIA PACK C Peptide test cups can be left on board of the TOSOH AIA System Analyzers 18 25 C for a maximum of 10 days 10 x 24 hours When stored over night at 2 8 C the test cups can be used for up to 30 days 30 cycles of 8 hours on board and 16 hours in the refrigerator Once the aluminum pouch is opened the test cups must be used within 30 days AIA PACK C Peptide CALIBRATOR SET and AIA PACK C Peptide SAMPLE DILUTING SOLUTION should be used within 1
23. none 20 82 75 10 15 83 16 21 102 4 5 0 10 10 58 11 29 106 7 2 5 10 5 31 5 81 109 3 1 0 10 2 20 2 46 111 8 Serum C2 none 22 55 7 5110 17 07 17 13 100 4 5 0 10 11 46 11 93 104 1 2 5 10 5 76 6 04 104 8 1 0 10 2 40 2 58 107 4 b 2 Dilution urine One urine sample containing high concentration of C peptide was serially diluted with the ATA PACK C Peptide SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery ng mL ng mL Urine A2 none 18 96 7 5 10 14 24 14 60 102 5 5 0 10 9 50 9 89 104 1 2 5 10 4 74 5 15 108 6 1 0 10 1 83 1 98 108 0 b 3 Dilution plasma Two plasma samples containing high concentrations of C peptide were serially diluted with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery ng mL ng mL EDTA none 22 02 plasma A2 75 10 16 61 17 24 103 8 5 0 10 11 13 11 82 106 2 2 5 10 5 60 6 05 108 0 1 0 10 2 28 2 52 110 8 Heparinized none 21 69 plasma A2 7 5110 16 37 16 94 103 5 5 0 10 10 98 11 76 107 0 2 5 10 5 50 6 01 109 1 1 0 10 2 20 2 44 110 8 CORRELATION a The correlation between serum x and heparinized plasma y on ST AIA PACK C Peptide was carried out using 50 patient specimens Slope 0 978 y Intercept 0 015 Correlation Coefficient 0 997 Range of Samples 10 115 Number of Samples 50 b The correlation between heparinized plasma x and EDTA plasma y on ST
24. specimens must be manually diluted in sample cups and the sample cups should be placed on the AIA 360 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 the AIA Nex IA AIA 21 ATA 600 H AIA 900 AIA 1800 and AIA 2000 B Assay Procedure 1 Ensure a sufficient quantity of ST AIA PACK C Peptide 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 ATA 600 II AIA 900 AIA 1800 and AIA 2000 will require ATA 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 CAP as Class I or by the CLSI as the clinical laboratory reagent water 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 CLSI document C3 A4 Preparation and Testing of Reagent Water in the Clinical Laboratory Approved Guideline Fourth Edition 3 If a specimen C peptide concentration is found to be greater than 30 ng
25. 1005971001 031D 4 CPep Immuno Enzymometric Assay C A SE TOSOH I C ST AIA PACK C Peptide 100597 1001 031D 20114 3 4 20094 5 3 20600AMZ01014000 1 C A E TOSOH TII C X7FE EIA EDTA WIE IREO C CPR 1 2 3 4 HBs HIV HCV 5
26. 20 Human Tissues Vol 3 pp 1 43 1983 2 Beyer J et al C Peptide Its Biogenesis Structure Determination and Clinical Significance Giernale Italiano di Chimica Clinica 4 Supp 1 pp 9 22 1979 EC REP TOSOH EUROPE N V 3 Rubenstein A et al Secretion of Proinsulin C Peptide by Pancreatic by Pancreatic B cells Transportstraat 4 and Its Circulation in Blood Nature 224 697 699 1969 B 3980 Tessenderlo Belgium 4 Horwitz D et al Circulating Serum C Peptide New England Journal of Medicine 295 Phone 32 13 66 88 30 207 209 1976 5 Rubenstein A et al Clinical Significance of Circulating C Peptide in Diabetes Mellitus and Fax 32 13 66 47 49 Hypoglycemic Disorders Archives of Internal Medicine 137 625 632 1977 6 Rendall M Expanding Clinical Use of C Peptide Radioimmunoassay Acta Diabetological Supplied TOSOH BIOSCIENCE INC Latine 20 105 113 1983 ppl by 6000 Shoreline Ct Suite 101 7 Hoogwerf B J Goetz F C Urinary C peptide A Simple Measure of Integrated Insulin ee Production with Emphasis on Body Size Diet and Corticosteroids J Clin Endocrinol Metab South San Francisco CA94080 USA 56 60 67 1982 Phone 1 650 615 4970 8 Kaneko T et al Demonstration of C Peptide Immunoreactivity in Various Body Fluids and Fax 1 650 615 0415 Clinical Evaluation of the Determination of Urinary C Peptide Immunoreactivity Endocrinol Tap 22 207 212 1975 Phone 800 248 6764 Fax
27. A 900 AIA 1800 and AIA 2000 PIPETTE TIPS 0019215 TIPRACK 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 WARNINGS AND PRECAUTIONS 1 The ST AIA PACK C Peptide is intended for in vitro diagnostic use only 2 Inspect the packaging and the exterior of the aluminura pouch for any sign of damage before use If any damages are visible contact your local TOSOH sales representative 3 Test cups from different lots or different assays should not be mixed within a tray 4 The ST AIA PACK C Peptide 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 5 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 6 Do not use beyond the expiration date 7 The ST AIA PACK C Peptide has been designed so that the high dose hook effect is not a problem for the vast majority of samples Serum heparinized plasma or EDTA plasma samples with C peptide concentrations between 30 and 90 ng mL will read
28. A Ez a term k emberi vagy llati forr sanyagokat tartalmaz ez rt lehets gesen fert6z6kent kell kezelni GF istruzioni perl 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 Versione Attuale CPEP 010311 A Il prodotto contiene materiali di origine umana o animale e va trattato come potenzialmente infettivo n voa k pou it v r zn ch jazyc ch je dostupn na na ich 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 Aktu ln Verze CPEP 010311 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 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 pastu info raqa eu tosoh com Naujausia Versija CPEP 010311 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 sektion
29. Al 0 68 21 35 22 03 19 83 90 0 0 68 10 68 11 35 10 30 90 7 0 68 5 34 6 01 5 54 92 1 Serum B1 0 21 21 35 21 56 19 61 90 9 0 21 10 68 10 89 9 91 91 1 0 21 5 34 5 55 4 93 88 9 Serum CI 0 42 21 35 21 77 19 65 90 3 0 42 10 68 11 09 10 10 91 1 0 42 5 34 5 75 5 17 89 8 a 2 Recovery urine One urine pool was spiked with three different levels of C peptide and assayed before and after spiking Sample Initial C peptide Expected Measured Percent Value Added Value Value Recovery ng mL ng mL ng mL ng mL Urine Al 4 99 21 35 26 35 23 59 89 5 4 99 10 68 15 67 14 02 89 4 4 99 5 34 10 33 9 56 92 5 a 3 Recovery plasma Two plasma pools were spiked with three different levels of C peptide and assayed before and after spiking Sample Initial C peptide Expected Measured Percent Value Added Value Value Recovery ng mL ng mL ng mL ng mL EDTA 1 83 21 35 23 18 21 03 90 7 plasma Al 1 83 10 68 12 51 11 71 93 6 1 83 5 34 7 17 6 69 93 4 Heparinized 1 90 21 35 23 25 21 17 91 1 plasma Al 1 90 10 68 12 57 12 02 95 6 1 90 5 34 7 24 6 74 93 2 b 1 Dilution serum Three serum samples containing high concentrations of C peptide were serially diluted with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery ng mL ng mL A Serum A2 none 18 47 7 5 10 14 00 14 32 102 3 5 0 10 9 40 9 79 104 2 2 5 10 4 74 5 03 106 3 1 0 10 1 91 2 11 110 4 Serum B2
30. SOH N C A7F FP C C 103 C 1 1 3 3 ng mL 2 1 2 SI f C ng mL SI p g L
31. abbit polycional antibody and 100 pL of anti C peptide mouse monoclonal antibody conjugated to bovine alkaline phosphatase with sodium azide as a preservative MATERIALS REQUIRED BUT NOT PROVIDED The following materials are required to perform C peptide analysis using the ST ATA PACK C Peptide Cat No 0025284 on the TOSOH AIA System Analyzers They are available separately from TOSOH Materials Cat No AIA Nex TA or AIA 21 0018539 AIA Nex TA or AIA 21 LA 0018540 AIA 1800 ST 0019836 ATA 1800 LA 0019837 AJA 2000 ST 0022100 ATA 2000 LA 0022101 AIA 600 II 0019014 AJA 600 II BCR 0019328 ATA 900 0022930 ATA 360 0019945 ATA PACK SUBSTRATE SET II 0020968 AIA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK C Peptide CALIBRATOR SET 0020384 AJA PACK C Peptide CALIBRATOR 1 0 ng mL AIA PACK C Peptide CALIBRATOR 2 0 5 ng mL approx AJA PACK C Peptide CALIBRATOR 3 2 ng mL approx AIA PACK C Peptide CALIBRATOR 4 6 ng mL approx ATA PACK C Peptide CALIBRATOR 5 15 ng mL approx AIA PACK C Peptide CALIBRATOR 6 33 ng ml approx AIA PACK C Peptide SAMPLE DILUTING SOLUTION 0020584 ATA PACK WASH CONCENTRATE 0020955 AIA PACK DILUENT CONCENTRATE 0020956 SAMPLE CUPS 0018581 ATA 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 AIA 600 II AI
32. c liver and renal desease Endocrinol Japon 26 65 73 1979 4 HBTIES Free CPR 21 2 97 104 1978 5 Free CPR 22 9 953 962 1979 Kaneko T et al Demonstration of C peptide immunoreactivity in various body fluids and clinical evaluation of the determination of urinary C peptide immunoreactivity Endocrinol Japon 22 207 212 1975 7 C peptide like Immunoreactivity CPR 4 30 7 587 593 1987 0015584 100 mL x4 8 Ohneda A et al C peptide in patients with insulinoma ed Baba S Kaneko T Yanaihara N Excerpta Medica Amsterdam 380 385 1979 9 ERAS CPR 25 1113 1119 1977 T 252 1123 2743 1 0120 17 1200 TEL 0467 76 5384 FAX 0467 79 2550
33. d above 2 Edit the calibration if necessary then accept the calibration For further information regarding calibration consult the TOSOH AIA System Operator s Manual lil Quality Control Procedure A Commercially Available Controls Commercially available controls should be run at least once 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 Serum heparinized plasma or EDTA plasma specimens do not require dilution prior to analysis Urine specimens should be diluted by more than 10 fold with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION prior to analysis Either diluted or undiluted patient specimens are placed in appropriate positions on the TOSOH AJA System Analyzers For the AIA 360 the urine
34. day and 7 days of opening or reconstituting respectively provided the vials or the bottles 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 for manual dilution ONLY and 2 the bottles 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 be used if they appear cloudy or discolored SPECIMEN COLLECTION AND HANDLING 1 Serum heparinized plasma EDTA plasma or urine is required for the assay Citrated plasma SHOULD NOT BE USED 2 When 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 3 When 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 4 For urine collect a 24 hour urine without preservative and keep the sample refrigerated during the collections process Record the total volume of the collection and use a well mixed aliquot for analysis Before assay clear the sample by filtration or centrifugation 5 Specime
35. en Trykte brugsanvisninger kan rekvireres pr fax 32 13 66 47 49 eller e mail info raqa eu tosoh com Nuverende Version CPEP 010311 A Dette produkt indeholder menneskelige eller animalske Bedienungsanleitungen in verschiedenen Sprachen sind auf unserer Webseite www tosohbioscience eu Im Kapitel Service 8 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 Aktuelle Version CPEP 010311 udgangsmaterialer og bor behandles som potentielt infektiost A Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle Infektionsquelle behandelt werden 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 Aktu l Versija CPEP 010311 A 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 wersj papierow mo na pyta pod nr faksu 32 13 66 47 49 lub e mailem info raqa eu tosoh com Aktualna Wersja CPEP 010311
36. mL in serum heparinized plasma or EDTA plasma or 300 ng mL in urine the specimen should be diluted with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 30 ng mL serum heparinized plasma or EDTA plasma or 300 ng mL urine is 1 10 It is desirable to dilute the specimen so that the diluted specimen reads between 5 0 and 15 0 ng mL in serum heparinized plasma or EDTA plasma or between 50 and 150 ng 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 C Peptide 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 specications must be entered under test code 059 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 C peptide concentration in ng mL For samples requiring dilution the AIA Nex IA AIA 21 AIA 600 II AIA 900 AIA 1800 and ATA 2000 will automatically perform dilutions and calculate res
37. malt ursprung och skall behandlas som potentiellt infekti s 1005971001 031D Rev 03 11 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 ALA 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 ATA AAM sur le CD pour P information appropri e ST AIA PACK C Peptide For Quantitative Measurement of C peptide in Serum Heparinized Plasma EDTA Plasma or Urine NAME AND INTENDED USE ST AIA PACK C Peptide is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of C peptide in human serum heparinized plasma EDTA plasma or urine on TOSOH AIA System Analyzers SUMMARY AND EXPLANATION OF TEST C peptide a polypeptide 31 amino acids in length originates in pancreatic B cells as a metabolically inert by product in the synthesis of insulin from proinsulin 1 Insulin and C peptide are released from proinsulin in equimolar concentrations into the portal circulation 2 Therefore C peptide levels can serve as an index to insulin secretion 3 4 Where insulin secretion is diminished as in insulin dependent diabetes low
38. n types should not be used interchangeably during serial monitoring of an individual patient Measured concentrations may vary slightly between sample types in certain patients 6 Samples may be stored at 2 8 C for up to 24 hours prior to analysis If the analysis cannot be performed within 24 hours the sample should be stored frozen at 20 C or below for up to 60 days 7 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 8 AII urine specimens should be diluted by more than 10 fold with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION prior to analysis The dilution factor is identified in the test file as Sp 2 The AIA Nex IA AIA 21 AIA 600 II AIA 900 AIA 1800 and AIA 2000 will automatically perform these dilutions and calculate the results 9 The sample required for analysis is 20 pL PROCEDURE For the AIA Nex 1A AJA 21 AIA 600 II AIA 900 ALA 1800 AIA 2000 and AIA 360 please refer to their Operator s Manual for detailed instructions l 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 and mix thoroughly to dissolve the solid material B Wash Solution Add the entire conten
39. o estan 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 raqga eu tosoh com Versi n Real CPEP 010311 A Este producto contiene tejidos de origen humano o animal y debe ser tratado como producto potencialmente infeccioso 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 raqa eu tosoh com Kehtiv Versioon CPEP 010311 A See toode sisaldab inim v i loomse p ritoluga aineid ning v ib olla nakkusohtlik fr 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 l adresse info raqa eu tosoh com Version Actuelle CPEP 010311 A Ce produit contient des substances animales ou humaines et doit par cons quent tre trait comme un produit potentiellement infectieux E instructiuni de utilizare n diverse limbi sunt disponibile pe site ul nostru www tosohbioscience eu la sec iunea Service amp Support Service si asisten tehnic
40. ons therapy etc 2 Using ST AIA PACK C Peptide the highest measurable concentration of C peptide in serum heparinized plasma or EDTA plasma specimens without dilution or in urine specimens diluted by 10 fold with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION is 30 ng mL which corresponds to 300 ng mL in original urine specimens and the lowest measurable concentration in serum heparinized plasma or EDTA plasma specimens without dilution or in urine specimens diluted by 10 fold with the AIA PACK C Peptide SAMPLE DILUTING SOLUTION is 0 2 ng mL assay sensitivity which corresponds to 2 0 ng mL in original urine specimens 3 Although the approximate value of the highest calibrator is 33 ng 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 30 ng mL which corresponds to 300 ng mL in original urine specimens dilution factor 10 4 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 5 Lipemia has an insignificant effect on the assay except in the case of gross lipemia where spatial interference may occur 6 Specimens from patients taking medicines and or medical treatment may show erroneous results 7 Samples containing fibrin may exhibit either falsely elevated or falsely decreased results 8 Specimens f
41. rom 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 C peptide 9 Serum concentrations typically increase post prandially 10 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 Reference Ranges The interval given here was determined in serum samples from 103 apparently healthy Asian individuals Serum Reference interval 1 1 3 3 ng mL Conversion Factors C peptide concentrations in this application are in units of ng mL Conversion to SI units of ug L may be made using the following equation Hg C peptide L ng C peptide mL x 1 0 PERFORMANCE CHARACTERISTICS ACCURACY a 1 Recovery serum Three serum pools were spiked with three different levels of C peptide and assayed before and after spiking Sample Initial C peptide Expected Measured Percent Value Added Value Value Recovery ng mL ng mL ng mL ng mL Serum
42. splayed in 1 10 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 AIA 21 AIA 600 II AIA 900 AIA 1800 and AIA 2000 will automatically calculate the concentrations of urine specimens using the dilution factor and report the results aC Pep 047 Calibrator Lot 2005604306080900 Ye Ax BZ P CUR Dp B Calibration Procedure Refer to the appropriate TOSOH AIA System Operator s Manual for the procedural instructions 2 Verify that both the calibrator iot and concentration numbers have been correctly entered into the software 3 The AIA PACK C Peptide CALIBRATOR 1 is provided ready for use 4 The AIA PACK C Peptide CALIBRATOR 2 6 are lyophilized All levels should be reconstituted with 1 0 mL of CAP Class I water or the clinical laboratory reagent water formally NCCLS Type I defined by CLSI C3 A4 guideline 5 TOSOH recommends that all calibrators be run in triplicate C Calibration Acceptability Criteria 1 The mean rate for the AIA PACK C Peptide 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 liste
43. ts of the AIA PACK WASH CONCENTRATE 100 mL to approximately 2 0 L of CAP Class I water or the clinical laboratory reagent water formally NCCLS Type I defined by CLSI C3 A4 guideline 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 water or the clinical laboratory reagent water formally NCCLS Type I defined by CLSI C3 A4 guideline 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 C Peptide have been standardized on WHO 1st IRP 84 510 1986 The calibration curve for ST AIA PACK C Peptide is stable for up to 90 days Calibration stability is monitored by quality control performance and is dependent on proper reagent handling and TOSOH AJA 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 for calculating results The concentration range of the calibration curve is di
44. ty C peptide 100 Proinsulin 31 5 Insulin ND N D not detectable SENSITIVITY The minimal detectable concentration MDC of C peptide is estimated to be 0 2 ng mL which corresponds to 2 0 ng mL in original urine specimens dilution factor 10 The MDC is defined as the concentration of C peptide which corresponds to the rate of fluorescence that is two standard deviations from the mean rate of fluorescence of 20 replicate determinations of the AIA PACK C Peptide CALIBRATOR 1 INTERFERENCE Interference is defined for the purposes of this study with recovery outside of 10 of the known concentration of the specimen after the following substances are added to human specimens 1 Hemoglobin up to 410 mg dL free bilirubin up to 16 mg dL and conjugated bilirubin up to 17 mg dL do not interfere with the assay 2 Lipemia as indicated by triglyceride concentration up to 1 600 mg dL does not interfere with the assay 3 Ascorbic acid up to 20 mg dL does not interfere with the assay 4 Protein as indicated by human albumin concentration up to 5 0 g dL does not interfere with the assay Shiba koen First Bldg 5 Heparin up to 100 U mL does not interfere with the assay 3 8 2 Shiba Minato ku Tokyo 105 8623 TOSOH CORPORATION 6 EDTA up to 10 mg mL does not interfere with the assay Japan RNN Phone 81 3 5427 5181 Beischer W Proinsulin and C peptide in Humans Hormones in Normal and Abnormal Fax 81 3 5427 52
45. ults if the dilution factors are entered into the software For detailed information regarding programming dilutions consult the appropriate TOSOH AIA System Operator s Manual 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 two levels of the internal control are run in order to accept the calibration curve The two 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 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 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 PROCEDURE 1 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 impressi
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