試薬添付文書
Contents
1. 2 121 C 20 3 1 2 8C 2 12 100 o mE E TOSOH I 1 0 mL 2 E TOSOH II E TOSOH II E TOSOH II E TOSOH Il TOSOH II 0015387 0015587 0015968 0015955 E TOSOH II2. 2 1 2 SI RAMS IB Cs AVF VY VIBES u g dL SI nmol L nmol L u g dL x 27 59 Cortisol 7 2 ACTH 3 ACTH CRF
3. B F 4 4 EDTA aD A H IE i EDTA MEWT lt TES Va iH LICH ALT Sie 2 8C 20 C Erlen 2 ARTERE O UR RM ORE V AL SHE TS EA 3 E TOSOH II 4 410 mg dL 17 mg dL 18 mg dL 1 600 mg dL 5 0 g dL 20 mg dL
4. de 1 i 1 E TOSOH II 1 FU Rate 20 nmol L s NETT 2 EFA b TOSOH H 6 FU E TOSOH Il 1 FU 30 2 100 20 E TOSOH I 3 10 15 4 0 2 60 u g dL 0 2 u g dL 1 6 1 FU y WH 2 x SD 10 5
5. 90 90 4 5 6 E TOSOH TII E TOSOH I REAR E TOSOH TII SUB MI E TOSOH II E TOSOH II
6. 90 6 60 u g dL 1 5 5 AIA 1800 IRCORT 044 Calibrator Lot 2002303806070000 log yy AllogaP Blog Clogx D B B0 100 90 80 70 60 50 40 30 20 10 0 01 1 10 100 Log Conc 1 1 E TOSOH II 2 3 366 6 4 21 0 y g dL
7. 2 3 1 EE TOSOH II 2 140 x L 10 u L 37 C 10 3 B F 4 363 nm 447 nm
8. 100 47 5 34 3 2 7 2 6 17 w 0 28 lt 0 001 lt 0 001 17 8 lt 0 001 6 y EIA x y 1 052 x 0 418 r 0 998 n 61 BB BECO AE y x y 1 016 x 0 223 r 0 997 n 67 EDTA mat y x y 1 000 x 0 113 r 0 990 n 130 1 1 2
9. AIA 1200 AIA 600 10 2 1 EIA 3 4 5 2 1 EIA
10. 100 U mL 6 2 8 C 15 25 C 1 1 E TOSOH I 15 25 C 1 2 8 C 7 2 E TOSOH I 2 SCRE CT E TOSOH H 1 6 BOTH SAREE 1 0 mL
11. DALOLT RSW BWR MCs Vv HEMI EDTA 1114 HT 3 x 7 8 2 1 HIV HBV HCV 2 3 1
12. 2 SCRE 1 E TOSOH I 4 E TOSOH II 1 E TOSOH I 1 100 mL 15 25 C 3 2 8 C 7 5 E TOSOH II 1 2 5 L 15 25 C 30 6 E TOSOH II 1 5L 15 25 C 30 2 1
13. 0015956 E TOSOH H gt 100mL x2 100 mL x2 1 WIESE EN EE 12 228 1984 2 115 9 594 1980 3 FINN FM STEHLE CJ HOFMANN K Synthetic tools for adrenocorticotropin receptor identification Biochemistry 24 1960 1985 4 115 9 559 1980 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 wer Tosoh 2 ST AIA PACK CORT Esponelicku noTpe ntenn Evrop t z kazn ci Europ iske kunder Europ ische Kunden European customers Evpwraior neAdarec Clientes europeos Euroopa kliendid Consommateurs europ ens Eur pai gyfelek Cli
14. 13 66 47 49 ali elektronski po ti info raqa eu tosoh com Aktualna Razli ica CORT 010410 A Ta izdelek vsebuje materiale love kega ali ivalskega izvora kar lahko privede do oku b 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 CORT 010410 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 sprak finns att tillg p var 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 CORT 010410 IN Denna produkt inneh ller material med humant eller animalt ursprung och skall behandlas som potentiellt infekti s 1006771001 040D Rev 04 10 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 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 Po
15. Rhythm in Plasma Cortisol 17 OHCS Concentration in Man J Clin Endocr 29 479 486 1969 6 Vermeulen A and Van der Straeten M Determination of Plasma Conisol bya Fluorometric Method J Clin Endocr 24 1188 1194 1964 7 Hubl W etal A Sensitive Direct Enzyme Immunoassay for Cortisol in Plasma and Saliva Exp Clin Endocrinol 84 63 70 1984 8 Young D Effects of Drugs on Clinical Laboratory Tests 3rd Edition Washington DC American Association for Clinical Chemistry Press 1990 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 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 ce Bu European Conformity In vitro diagnostic medical device Consult instructions for use Temperature limitation LOT 8 Authorized representative in the European Community Supplied by y Catalogue number Supplied by Sufficient for Part number Batch code Lot number Manufacturer Use by date
16. The beads are washed to remove the unbound enzyme labeled cortisol and are then incubated with a fluorogenic substrate 4 methylumbelliferyl phosphate 4MUP The amount of enzyme labeled cortisol that binds to the beads is inversely proportional to the cortisol concentration in the test sample A standard curve using a range of known standard concentrations is constructed and unknown cortisol concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK CORT Cat No 0025287 Plastic test cups containing lyophilized twelve magnetic beads with anti cortisol rabbit polyclonal antibody and 140 pL of cortisol 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 cortisol analysis using the ST AIA PACK CORT Cat No 0025287 on the TOSOH AIA System Analyzers They are available separately from TOSOH Materials Cat No AIA Nex IA or AIA 21 0018539 AIA Nex IA or AIA 21 LA 0018540 AIA 1800 ST 0019836 AIA 1800 LA 0019837 ATA 2000 ST 0022100 AIA 2000 LA 0022101 AIA 600 II 0019014 AIA 600 II BCR 0019328 AJA 360 0019945 AIA PACK SUBSTRATE SET I 0020968 AIA PACK SUBSTRATE REAGENT II AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK CORT CALIBRATOR SET 0020387 AIA PACK CORT CALIBRATOR 1 0 ng dL AIA PACK CORT CALIBRATOR 2 0 63 yg dL approx AIA PACK CORT CALIBRATOR 3 2 1 g dL approx AIA PACK COR
17. 00 1 E TOSOH I 2 E TOSOH I E TOSOH I HER 1 E TOSOH I 2 E TOSOH U 3 EFA b TOSOH I 4 E TOSOH H 5 E TOSOH H 6 E TOSOH U E TOSOH II SUB II 1 E TOSOH IL 4 2 E TOSOH II E TOSOH II 6 E TOSOH UFER Oo gl 1 1
18. 1006771001 040D 4 Enzyme Immunoassay A E TOSOH M ST AIA PACK CORT x xl x xD 1006771001 040D 2010 4 4 2009 3 3 13A2X00174000012 EEE RE E TOSOH I 9 EA ic k AM NV VIER IE EDTA MERO IVF V VIE AE 1 2 3 4 HBs HIV HCV 5 6 AIA 1200 AIA 6
19. 98 0 Serum Bi 15 30 7 85 23 14 23 05 99 6 15 30 15 69 30 99 31 43 101 4 15 30 31 38 46 68 49 33 105 7 Serum C1 10 94 7 85 18 79 18 67 99 3 10 94 15 69 26 63 26 52 99 6 10 94 31 38 42 32 42 94 101 5 b Dilution Three serum samples containing high concentrations of cortisol were serially diluted with the AIA PACK CORT SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery ug dL ug dL Serum A2 none 47 25 7 5 10 35 44 36 89 104 1 5 0 10 23 63 25 25 106 9 2 5 10 11 81 12 25 103 7 1 0 10 4 73 4 85 102 7 Serum B2 none 50 32 75 10 37 74 38 08 100 9 5 0 10 25 16 25 48 101 3 2 5 10 12 58 12 36 98 3 10 10 5 03 4 83 95 9 Serum C2 none 52 18 75 10 39 13 41 49 106 0 5 0 10 26 09 gt 771 106 2 2 5 10 13 04 13 28 101 8 1 0 10 5 22 521 99 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 ug dL ug dL Serum A3 5 32 0 167 31 Serum B3 21 69 0 556 2 6 Serum C3 41 16 1 039 2 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 pooled standard deviation SD and coefficient of variation CV S
20. CEDURAL NOTES Lyophilized substrate must be completely dissolved 2 Ligand assays performed by the TOSOH AJA 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 cortisol concentration is found to be greater than the upper limit of the assay range 60 pg dL the specimen should be diluted with the AIA PACK CORT SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 60 pg dL is 1 3 It is desirable to dilute the specimen so that the diluted specimen reads between 10 and 50 pg dL 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 AJA System Analyzers can store two different calibration curves for each analyte at one time Therefore up to two different lots of ST AIA PACK CORT test cups can be used during the same run 5 Ifthe assay specifications for this test a
21. LIBRATOR 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 17 mg dL and conjugated bilirubin up to 18 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 added albumin up to 5 0 g dL does not interfere with the assay 5 Heparin up to 100 U mL does not interfere with the assay N Baxter J D Rousseau G G Glucocorticoid Hormone Action An Overview In Baxter J D and Rousseau G G eds i Glucocorticoid Hormone Action Springer Verlag Berlin and New York 1979 2 Daliman M F Yates F E Dynamic Asymmetries in The Corticosteroid Feedback Path and Distribution Metabolism Binding Elements of The Adrenocortical System Annals of New York Academy of Sciences 156 696 721 1969 3 Keller Wood M E and Dallman M F Corticosteroid Inhibition of ACTH Secretion Endocrine Reviews 5 1 24 1984 4 Weitzman E D Schaumburg H and Fishbein W Plasma 17 Hydroxycorticosteroid Levels During Sleep in Man J Clin Endocr 26 121 127 1966 5 Orth D N and Island D P Light Synchronization of Circadian
22. OSOH 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 MS 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 2 Using ST AIA PACK CORT the highest measurable concentration of cortisol in specimens without dilution is 60 g dL and the lowest measurable concentration in specimens is 0 2 ug dL assay sensitivity 3 Although the approximate value of the highest calibrator is 68 ug dL the exact concentration may be slightly different The assay specification ASSAY RANGE HIGH should be defined as the upper limit of the assay range 60 ug dL 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 For a more complete understanding of the limitations of this procedure pl
23. T CALIBRATOR 4 6 3 ug dL approx AIA PACK CORT CALIBRATOR 5 21 Hg dL approx AIA PACK CORT CALIBRATOR 6 68 Hg dL approx AIA PACK CORT SAMPLE DILUTING SOLUTION 0020587 AIA PACK WASH CONCENTRATE 0020955 AIA PACK DILUENT 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 AIA 600 II 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 CORT is intended for in vitro diagnostic use only 2 Test cups from different lots or different assays should not be mixed within a tray 3 The ST AIA PACK CORT 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 s
24. aintenance 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 AJA 1800 follows and shows the algorithm used for calculating results BCORT 044 Calibrator Lot 2002303806070000 log gyer Y Alloge Alog Clogx D B BO 100 90 80 20 60 50 40 30 20 10 0 01 1 19 100 Log Gone 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 The AIA PACK CORT CALIBRATOR SET is 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 Since there is an inverse relationship between concentration and rate the rate should decrease as the concentration increases 2 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 Com
25. ample Mean Pooled SD CV ug dL ug dL Serum A3 5 32 i 0 209 3 9 Serum B3 21 69 0 930 4 3 Serum C3 41 16 1 896 4 6 CORRELATION a The correlation between serum x and heparinized plasma y on ST AIA PACK CORT was carried out using 67 patient specimens Slope 1 016 y Intercept 0 223 Correlation Coefficient 0 997 Range of Samples 70 58 7 Number of Samples 67 b The correlation between serum x and EDTA plasma y on ST AIA PACK CORT was carried out using 130 patient specimens Slope 1 000 y Intercept 0 113 Correlation Coefficient 0 990 Range of Samples 18 279 Number of Samples 130 SPECIFICITY The following substances were tested for cross reactivity The cross reactivity is the percentage of the compound which will be identified as cortisol If these compounds are present in the specimen at the same concentration as cortisol the final result will be increased by these percentages Compound Cross reactivity Cortisol 100 Prednisolone 475 Cortisone 34 3 Prednisone 2 7 Corticosterone 2 6 17a hydroxyprogesterone 0 28 Testosterone lt 0 001 Progesterone lt 0 001 17B estradiol lt 0 001 SENSITIVITY The minimal detectable concentration MDC of cortisol is estimated to be 0 2 ug dL The MDC is defined as the concentration of cortisol which corresponds to the rate of fluorescence that is two standard deviations from the mean rate of fluorescence of 20 teplicate determinations of the AIA PACK CORT CA
26. ease 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 8 Reference Ranges Because of the diurnal variation and circadian rhythm of cortisol secretion specimens drawn at 8 A M should represent peak levels in normal individuals Specimens drawn at 11 P M will typically be 25 of the peak level The interval given here was determined in serum samples which were collected in the morning from 366 apparently healthy Asian individuals Reference Interval 6 4 21 0 zg dL 177 578 nmol L Conversion Factors Cortisol concentrations in this application are in units of zg dL Conversion to SI units of nmol L may be made using the following equations nmol cortisol L yg cortisol dL x 27 59 PERFORMANCE CHARACTERISTICS ACCURACY a Recovery Three serum pools were spiked with three different levels of cortisol and assayed before and after spiking Sample Initial Cortisol Expected Measured Percent Value Added Value Value Recovery g dL ug dL g dL ug dL Serum Al 8 37 7 85 16 21 z 15 53 95 8 8 37 15 69 2406 2419 100 5 8 37 31 38 39 75 38 94
27. eir Operator s Manual for detailed instructions Reagent Preparation A Substrate Solution Bring all reagents to 18 25 C before preparing the working reagent Add the entire contents of the AIA PACK SUBSTRATE RECONSTITUENT U 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 1 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 CORT were compared to IRMM ERM DA192 193 reference materials The average recovery of these reference materials are 105 and 94 respectively The calibration curve for ST AIA PACK CORT 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 m
28. en fert z kent kell kezelni 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 CORT 010410 va u 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 Naujausia Versija CORT 010410 A Il prodotto contiene materiali di origine umana o animale e trattato come potenzialmente infettivo 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 Lieto anas instrukcijas da d s valod s ir pieejamas m su interneta vietn www tosohbioscience eu sada Service amp Support T e mail info raqa eu tosoh com Nuv rende Version CORT 010410 A Dette produkt indeholder menneskelige eller animalske udgangsmaterialer og bor behandles som potentielt infektigst Bedienungsanleitungen in verschiedenen Sprachen sind auf unse
29. enti europei Europos klientai Eiropas klienti Klienci europejscy Clientes europeus Clientii europeni Evropski kupci Eur pski zakaznici Europeiska kunder UncTpyKunn 3a ynotpe a Ha pas myHN esnum ca Ha pasNonokenne Ha Hanma ye6caitr www tosohbioscience eu s pasea Momom u nopappxka Service amp Support Xaprueno konne Moxe na Op mony4eHo Ha fax 32 13 66 47 49 nnn e mail info raqa eu tosoh com Axtyanna Bepcna CORT 010410 IN Tosn TPOIIYKT CpD2K3 Marepual C YOBEIIKH WIM KMBOTMHCKM Iipomsxog M TPAOBa Ja ObAe TPeTupaH KATO HOTEHLMANHO UHQEKIUMO3EH N vod 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 Tist nou verzi m ete obdr et faxem slo 32 13 66 47 49 nebo e mailem info raqa eu tosoh com Aktu ln Verze CORT 010410 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 EU rev CORT 010410 ce A Haszn lati utasit s t bb nyelven elerhet6 websz jtunkon www tosohbioscience eu a Service amp Support Szolg ltat s s T mogat s szekci alatt Nyomtatott v ltozat igenyelhet faxon a 32 13 66 47 49 es telefonsz mon vagy e mailben info raqa eu tosoh com Aktu lis V ltozat CORT 010410 A Ez a term k emberi vagy llati forr sanyagokat tartalmaz ez rt lehets ges
30. i n impresa a trav s del fax 32 13 66 47 49 o por correo electr nico info raqa eu tosoh com Versi n Real CORT 010410 A Este producto contiene tejidos de origen humano o animal y debe ser tratado como producto potencialmente infeccioso et ci 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 CORT 010410 A See toode sisaldab inim v i loomse p ritoluga aineid ning v ib olla nakkusohtlik Br r 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 raga eu tosoh com Version Actuelle CORT 010410 IN Ce produit contient des substances animales ou humaines et doit par cons quent tre trait comme un produit potentiellement infectieux 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 CORT 010410 IN Sis produkts satur cilveku vai dzivnieku izejmateri lus un ir uzskat ms par potenci li infekciju saturo u Instrukcja Uzytkowania w r znych jezykach jest dostepna na naszej stronie interne
31. mercially 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 Operators 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 the specific instructions in the Operators 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 ALA 600 II AIA 1800 AJA 2000 and AIA 360 B Assay Procedure 1 Ensure a sufficient quantity of STAIA PACK CORT test cups for the unbe 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 PRO
32. pecimens and controls 5 Do not use beyond the expiration date 6 TOSOH AIA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST AIA PACK CORT assay 7 For safe waste disposal it is recommended that each laboratory complies with established laboratory procedures and local state and federal regulations 8 Inspect the packaging and the exterior of the aluminum pack for any sign of damage before use If any damages are visible contact your local TOSOH sales representative s 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 CORT 0025287 AJA PACK CORT CALIBRATOR SET 0020387 AIA PACK CORT SAMPLE DILUTING SOLUTION 0020587 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 CORT test cups may be stored at 18 25 C for up to 1 day AJA PACK CORT CALIBRATOR SET and AIA PACK CORT SAMPLE DILUTING SOLUTION should be used within 1 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 stable for 30 days at 18 25 C Reagen
33. re not ready in the system software the specifications must be entered under test code 067 CALCULATION OF RESULTS The TOSOH AIA System Analyzers perform all alv 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 cortisol concentration in g dL 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 Sp cimen 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 T
34. rer 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 raga eu tosoh com Aktuelle Version CORT 010410 IN Dieses Produkt enth lt menschliches oder tierisches Basismaterial und sollte daher wie eine potenzielle Infektionsquelle behandelt werden Oa Ppeite tc OSnyies xpijang oe noits yAWooEs OTH StadiktvaKh tono8ecia pac www tosohbioscience eu otnv evornra Service amp Support Mnopeite va AdPete tn v evrunn popoh vroP llovras aitnon j cw paz otov ap du 32 13 66 47 49 y HEOWw NAEKTPOVIKOV Taxv poneiov info raga eu tosoh com Tpexovoa Ekdoon CORT 010410 A To npo v avt repi xel vluc avdpwnuvng fork rpo devons kat da np ns va avr netwnileta wc Suvyntixd podvopatiKd 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 raga eu tosoh com Actual Version CORT 010410 IN 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 vers
35. towej www tosohbioscience eu w zakladce 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 CORT 010410 A Produkt zawiera material pochodzenia ludzkiego lub zwierzecego i dlatego nale y go traktowa 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 secc o Service amp Support Servicos e Assist ncia Pode ainda obter uma vers o em papel atrav s do fax 32 13 66 47 49 ou do email info raga eu tosoh com Vers o Actual CORT 010410 IN Este produto cont m materiais de origem humana ou animal e deve ser tratado como 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 Versiune Actual CORT 010410 IN Acest produs contine materiale de provenient uman sau animal si trebuie tratate ca potential infectioase 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
36. ts 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 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 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 5 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 6 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 7 Diluted serum heparinized plasma or EDTA plasma should be used within 24 hours and should not be stored 8 The sample required for analysis is 10 uL PROCEDURE For the AIA Nex IA AIA 21 AIA 600 II AIA 1800 AIA 2000 and AIA 360 please refer to th
37. ur 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 CORT For Quantitative Measurement of cortisol in Serum Heparinized Plasma or EDTA Plasma NAME AND INTENDED USE ST AIA PACK CORT is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cortisol in human serum heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers SUMMARY AND EXPLANATION OF TEST Cortisol the major glucocorticoid produced by the adrenal cortex regulates glucose lipid and protein metabolism and has anti inflammatory and immunosuppressive effects 1 2 The cortisol level in circulation is regulated by adrenocorticotropic hormone ACTH 3 ACTH is produced by the pituitary gland and is regulated by the hypothalamus with corticotropin releasing factor s CRF J The cortisol itself also negatively regulates ACTH production Therefore measurement of cortisol in blood and monitoring a circadian pattern 4 5 can provide information to evaluate hypothalamic pituitary adrenal function as well as clinical diagnosis 6 7 PRINCIPLE OF THE ASSAY The ST AIA PACK CORT is a competitive enzyme immunoassay which is performed entirely within the ST AIA PACK CORT test cups Cortisol present in the test sample competes with enzyme labeled cortisol for a limited number of binding sites on a cortisol specific antibody immobilized on magnetic beads
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