試薬添付文書
Contents
1. 90 90 4 5 6 E TOSOH II CA19 9 E TOSOH II CA19 9 E TOSOH II SUB Il E TOSOH I2. B F 4 4 BZD MISS Y YA MO CA19 9 l RE MI SY VRAT RA MENS Y MEL 8C 20 C 2 3 BE TOSOH II CA19 9 4 390 mg dL 17 mg dL ET HEN 18 mg dL 1 600 mg dL 2 5 g dL
3. 363 nm 447 nm CA19 9 O O 90 6 400 U mL 1 5 5 AIA 1800 22 Galibrator Lot 2000704906070000 Y 4 0 100 200 300 400 Conc 1 1 E TOSOH Il CA19 9
4. 1 E TOSOH II CA19 9 CA19 9 Hi CA19 9 2 EFA t TOSOH I CA19 9 E TOSOH U CA19 9 1 E TOSOH I CA19 9 2 E TOSOH II CA19 9 3 E TOSOH Il CA19 9 4 E TOSOH I CA19 9 5 E TOSOH TII CA19 9 6 3 E TOSOH II CA19 9 4 TOSOH II SUB II 1 E TOSOH II 4 2 E TOSOH Il 5 E TOSOH II 6 BE TOSOH I CA19 9 1 1 AIA 1200 AIA 600
5. 3 1 2 121 C 20 3 1 2 8C 2 127 100 1 1 0 mL x2 2 6 1 0 mL x2 100 mL x2 100 mL x24 E TOSOH H CA
6. CA19 9 6 9 CA19 9 OM 1 1 E TOSOH I CA19 9 1 FU Rate 8 nmol L s 2 E TOSOH I CAI9 9 1 BE TOSOH I CA19 9 6 FU CA19 9 FU okk 0 1 1 0 nmol L s U mL FU FU Olh A B C A 6 FU B 1 FU C 6 CA19 9 nmol L s nmol L s U mL 2 DE 100 20 MATT RE CA19 9 E TOSOH
7. 2 8 C 90 3 E TOSOH II CA19 9 1 E TOSOH II CA19 9 2 6 1 0 mL 2 8 C 1 E TOSOH TII CA19 9 4 E TOSOHI II 1 E TOSOH II 1 100 mL 15 25C 3 i 2 8 C 7 5 E TOSOH I 1 2 5 L 15 25 C 30
8. 10 2 CA19 9 1 PEIA IEMA 3 CA19 9 CA19 9 4 5 2 1 BIA IEMA CA19 9 CA19 9
9. CA19 9 2 3 100 IOO 200 48 CA19 9 2SD 37 U mL 2 1 2 Si CA19 9 U mL SI kU L kU CA19 9 L U CA19 9 mL x 1 0 CA19 9 Carbohydrate Antigen 19 9 1979 Koprowski 2 CA19 9 A 3 5 CA19 9
10. 20 mg dL 100 U mL 5 EDTA 6 2 8 C 15 25 C 1 1 E TOSOH II CA19 9 15 25 C 1 2 8 C 7 BURA IIE E TOSOH II CA19 9 2 8 C 7 15 25 C ST
11. 6 E TOSOH II 1 5L 15 25 C 30 2 2 1 2 3 1 E TOSOH II CA19 9 2 100 L 50 u L 37 C 10 3 B F 4
12. E TOSOH I 7 CAI9 9 3 8 HAMA Human Anti mouse Antibody 2 1 HIV HBV HCV 2
13. II CA19 9 3 10 15 4 1 0 400 U mL 1 0 U mL 1 6 1 FU y WA 2 x SD 10 200 000 U mL 5 y EIA x y 1 031 x 2 23 r 0 993 n 60 y x y 0 990 x 0 144 r 0 999 n 107 1 1 2
14. rica favor de referirse a los documentos ATA 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 ATA AAM que est o em CD para informac 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 CA19 9 For Quantitative Measurement of carbohydrate antigen 19 9 hereinafter called CA 19 9 which is the registered trademark of Fujirebio Diagnostics Inc in Serum or Heparinized Plasma NAME AND INTENDED USE ST AIA PACK CA19 9 is designed for IN VITRO DIAGNOSTIC USE ONLY for quantitative measurement of CA 19 9 in human serum or heparinized plasma on TOSOH AIA System Analyzers SUMMARY AND EXPLANATION OF TEST Carbohydrate antigen 19 9 CA 19 9 is a digestive cancer associated antigen found by Koprowski and his co workers in 1979 1 2 CA 19 9 is an antigen holding sialyl Lewis A glycated chain as an antigen determinant and is present in blood in the form of mucin glycoprotein 3 5 CA 19 9 is contained in such as pancreas gallbladder meconium and saliva as well as in tumor tissues Elevated serum CA 19 9 levels have been reported in patients with pancreatic cancer biliary cancer carcinoma of colon and rectum and liver cancer Many of these examples are observed in pancreatic and biliary cancers 6 8 Since false positive rate is
15. less for benign diseases measurement of CA 19 9 is widely used as an effective test for diagnosis of malignant tumors of pancreas and biliary and as an effective tool to make a decision of medical treatment effectiveness and to do follow ups PRINCIPLE OF THE ASSAY The ST AIA PACK CA19 9 is a two site immunoenzymometric assay which is performed entirely in the ALA PACK test cups CA 19 9 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme labeled monoclonal antibody in the AIA PACK test cups The magnetic beads are washed to remove unbound enzyme labeled monoclonal antibody and are 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 CA 19 9 concentration in the test sample A standard curve is constructed and unknown sample concentrations are calculated using this curve MATERIAL PROVIDED ST AIA PACK CA19 9 Cat No 0025271 Plastic test cups containing lyophilized twelve magnetic beads coated with anti CA 19 9 mouse monoclonal antibody and 100 pL of anti CA 19 9 mouse monoclonal antibody to CA 19 9 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 CA 19 9 analysis using the ST AIA PACK CA19 9 Cat No 0025271 on the
16. 1001571001 069C 3 Immuno Enzymometric Assay 1 9 9 N GE TOSOH I CA19 9 ST AIA PACK CA19 9 1001571001 069C 2009 6 3 2008 10 2 20400AMZ00913000 A HE 1 9 9 OE TOSOH I CA19 9 EIA CA19 9 1 2 3 4 HBs HIV HCV 5 6 AIA 1200 AIA 600
17. 19 9 0015371 E TOSOH I CA19 9 1 1 eat REARK E TOSOH II 0015968 E TOSOH I E TOSOH Il E TOSOH I BE TOSOH 1 Koprowski H Steplewski Z Mitchell K Herlyn M Herlyn D and Fuhrer P Colorectal carcinoma antigens detected by hybridoma antibodies Somatic Cell Genetics 5 957 1979 2 Herlyn M Steplewski Z and Koprowski H Colorectal carcinoma specific antigen Detection by means of monoclonal antibodies Proc Natl Acad Sci U S A 76 1437 1979 3 Magnani J Brockhaus M Smith D Ginsburg V Blaszczyk M Mitchell K Steplewski Z and Koprowski H A Monosialoganglioside is a monoclonal antibody defined antigen of colon carcinoma Science 212 53 1981 4 Magnani J Nilson B Brockhaus M Zopf D Steplewski Z Koprowski H and Ginsburg V A Monoclonal antibody defined antigen associated with gastrointestinal cancer is a ganglioside containing sialylated lacto N fucopentaose II J Biol Chem 257 14365 1982 5 Magnani J Steplewski Z Koprowski H and Ginsburg V Identification of the gastrointestinal and pancreatic cancer associated antigen detected by monoclonal antibody 19 9 in the sera of patients as a mucin Cancer Research 43 5489 1983 6 De
18. 2 none 361 4 75 10 271 1 287 7 106 1 5 0 10 180 7 199 6 110 4 2 5 10 90 4 103 1 114 2 1 0 10 36 1 40 4 111 8 PRECISION a Within run precision was determined using three controls in a total of 20 runs Within each run one set of duplicates per control was assayed The mean of each duplicate was used to obtain the pooled standard deviation SD which was then used to calculate the coefficient of variation CV Sample Mean Pooled SD CV U mL U mL Serum A3 20 5 0 572 2 8 Serum B3 30 3 0 766 2 5 Serum C3 59 2 1 349 2 3 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 Sample Mean Pooled SD CV U mL U mL Serum A3 20 5 0 897 44 Serum B3 30 3 1 202 40 Serum C3 59 2 2 330 3 9 CORRELATION The correlation between serum x and heparinized plasma y on ST AIA PACK CA19 9 was carried out using 107 patient specimens Slope 0 990 y Intercept 0 144 Correlation Coefficient 0 999 Range of Samples 4 8 375 5 Number of Samples 107 SENSITIVITY The minimal detectable concentration MDC of CA 19 9 is estimated to be 1 0 U mL The MDC is defined as the concentration of CA 19 9 which corresponds to the rate of fluorescence that is two standard deviations from the estimated mean rate of fluorescence of 10 replicate determinations of a CALIBRATOR 1 INTERFEREN
19. 9 9 SAMPLE DILUTING SOLUTION 0020571 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 CA19 9 test cups may be stored at 18 25 C for up to 1 day Calibrators and Sample Diluting Solution should be used within 1 day and 7 days of opening or reconstituting respectively provided the vials are kept tightly sealed and refrigerated at 2 8 C They should be used after equilibrating to 18 25 C for about 30 minutes The Sample Diluting Solution can be used for up to 90 days provided that 1 it is used with only ST AIA PACK CA19 9 2 it is used for manual dilutions ONLY and 3 the vials are kept tightly sealed and refrigerated immediately after use Reconstituted substrate solution is stable for 3 days at 18 25 C or 7 days at 2 8 C Working diluent and wash solutions are stable for 30 days at 18 25 C Reagents should not be used if they appear cloudy or discolored SPECIMEN COLLECTION AND HANDLING Serum or heparinized plasma is required for the assay EDTA and citrated plasma SHOULD NOT BE USED If using serum a venous blood sample is collected aseptically without additives Store at 18 25 C until a clot has formed usually 15 45 minutes then centrifuge to obtain the serum specimen for assay If using heparinized plasma a venous blood sample is collected aseptically with d
20. 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 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 ATA 600 II ATA 1800 AIA 2000 and AIA 360 B Assay Procedure 1 Ensure a sufficient quantity of ST AIA PACK CA19 9 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 TA ATA 21 AIA 600 II AIA 1800 and ALA 2000 will require AIA PACK SAMPLE TREATMENT CUPs if onboard dilutions are utilized PROCEDURAL NOTES 1 Lyophilized substrate must be completely dissolved 2 Ligand assays performed by the TOSOH AIA System Analyzers require that the laboratory use water designated by the College of American Pathologists as Class 1 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 Re
21. CA 19 9 is provided ready for use TOSOH recommends that all calibrators should be run in triplicate 4 CALIBRATOR 2 6 for ST AIA PACK CA19 9 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 Ill 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
22. CE 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 Hemoglobin up to 390 mg dL 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 2 5 g dL does not interfere with the assay Heparin up to 100 U mL does not interfere with the assay REFERENCES 1 Koprowski H Steplewski Z Mitchell K Herlyn M Herlyn D and Fuhrer P Colorectal Carcinoma Antigens Detected by Hybridoma Antibodies Somatic Cell Genetics 5 957 1979 2 Herlyn M Steplewski Z and Koprowski H Colorectal Carcinoma Specific Antigen Detection by Means of Monoclonal Antibodies Proc Natl Acad Sci U S A 76 1437 1979 3 Magnani J Brockhaus M Smith D Ginsburg V Blaszczyk M Mitchell K Steplewski Z and Koprowski H A Monosialoganglioside is a Monoclonal Antibody Defined Antigen of Colon Carcinoma Science 212 53 1981 Magnani J Nilson B Brockhaus M Zopf D Steplewski Z Koprowski H and Ginsburg V A Monoclonal Antibody Defined Antigen Associated with Gastroint
23. TOSOH AIA System Analyzers They are available separately from TOSOH Materials Cat No AIA Nex IA or AJA 21 0018539 AIA Nex IA or AIA 21 LA 0018540 AIA 1800 ST 0019836 AIA 1800 LA 0019837 AIA 2000 ST 0022100 AJA 2000 LA 0022101 AIA 600 II 0019014 ATA 600 II BCR 0019328 AIA 360 0019945 AIA PACK SUBSTRATE SET H 0020968 AIA PACK SUBSTRATE REAGENT H AIA PACK SUBSTRATE RECONSTITUENT II AIA PACK CA19 9 CALIBRATOR SET 0020371 CALIBRATOR 1 0 U mL CALIBRATOR 2 25 U mL approx CALIBRATOR 3 50 U mL approx CALIBRATOR 4 100 U mL approx CALIBRATOR 5 200 U mL approx CALIBRATOR 6 420 U mL approx AIA PACK CA19 9 SAMPLE DILUTING SOLUTION 0020571 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 I 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 ASSAY PREPARATION 1 Set up the TOSOH AIA System Analyzers for CA 19 9 analysis REFER TO THE APPROPRIATE TOSOH AIA SYSTEM ANALYZERS OPERATOR S MANUAL 2 Bring all test sa
24. agent 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 CA 19 9 concentration is found to be greater than the upper limit of the assay range 400 U mL the specimen should be diluted with the AIA PACK CA19 9 SAMPLE DILUTING SOLUTION and reassayed according to the Assay Procedure The recommended dilution for specimens containing greater than 400 U mL is 1 10 or 1 100 It is desirable to dilute the specimen so that the diluted specimen reads between 20 and 400 U 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 CA19 9 test cups can be used during the same run 5 If the assay specifications for this test are not ready in the system software the specifications must be entered under test code 015 CALCULATION OF RESULTS The TOSOH AJA 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 CA 19 9 concentration in U mL For samples requiring dilution the AIA Nex IA AIA 21 ATA 600 II AIA 1800 and AIA 2000 will automatically perfor
25. esignated 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 zL PROCEDURE For the AIA Nex IA AIA 21 ATA 600 II AIA 1800 ATA 2000 and ATA 360 please refer to their Operator s Manual for detailed instructions I 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 I 100 mL to the lyophilized ATA 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
26. estinal Cancer is a Ganglioside Containing Sialylated Lacto N Fucopentose II J Biol Chem 257 14365 1982 Magnani J Steplewski Z Koprowski H and Ginsburg V Identification of the Gastrointestinal and Pancreatic Cancer Associated Antigen Detected by Monoclonal Antibody 19 9 in the Sera of Patients as a Mucin Cancer Res 43 5489 1983 Delvillano B Brennan S Brock P Bucher C Liu V McClure M Rake B Space S Westrick B Shoemaker H and Zurawski V Radioimmunometric Assay for Monoclonal Antibody Defined Tumor Marker CA 19 9 Clin Chem 29 549 1983 Pleskow D K Berger H J Gyves J Allen E McLean A Podolsky K Evaluation of a Serological Marker CA19 9 in the Diagnosis of Pancreatic Cancer Annals Int Med 110 704 1989 Ritts R E Del Villano B C Go V L W Herberman R B Klug T L Zurawski V R Initial Clinical Evaluation of an Immunoradiometric Assay for CA 19 9 using the NCI Serum Bank Int J Cancer 33 339 1984 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 gt TOSOH BIOSCIENCE INC Supplied by 000 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 wm i ff z In vitro diagnostic Consult instructions Temperature limitation Use by date medical d
27. evice for use LOT ud Batch code Lot number Manufacturer Supplied by Sufficient for Catalogue number 1 Part number
28. lvillano B Brennan S Brock P Bucher C Liu V McClure M Rake B Space S Westrick B Shoemaker H and Zurawski V Radio immunometric assay for monoclonal antibody defined tumor marker CA19 9 Clin Chem 29 549 1983 7 Delvillano B and Zurawski V The carbohydrate antigenic determinant 19 9 CA19 9 A monoclonal antibody defined tumor marker The national conference on immuno diagnostics 269 1983 CA19 9 IAL 6 1087 1985 9 19 9 CA19 9 48 931 1990 po 252 1123 2743 1 0120 17 1200 TEL 0467 76 5384 FAX 0467 79 2550 TosoH 3 8 2 TEL 03 5427 5181 FAX 03 5427 5220 Tosoh 2 1001571001 069C Rev 06 09 Attention For North and South American Customers Please refer to the AIA AAM Docs on CD for the appropriate information Para los Clientes en Norte y Sur Am
29. m 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 control 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 res
30. 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 CA19 9 are prepared gravimetrically and are compared to internal reference standards The calibration curve for ST AIA PACK CA19 9 is stable for up to 90 days Calibration stability is monitored by quality control performance and is dependent on proper reagent handling and TOSOH AIA System maintenance according to the manufacturer s instructions Recalibration may be necessary more frequently if controls are out of the established range for this assay or when certain service procedures are performed e g temperature adjustment sampling mechanism changes maintenance of the wash probe or detector lamp adjustment or change For further information regarding instrument operation consult the TOSOH AIA System Operator s Manual A sample calibration curve from AIA 1800 follows and shows the algorithm used for calculating results Calibrator Lot 2000704906070000 Ar Bx Cx D Rate 70 60 50 40 30 20 10 0 0 100 200 300 400 Cono 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
31. mples and controls to 18 25 C and mix well RT AND PRECAUTIONS The ST AIA PACK CA19 9 is intended for in vitro diagnostic use only A Test cups from different lots or different assays should not be mixed within a tray 3 The ST AIA PACK CA19 9 contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides When disposing of such reagents always flush with large volumes of water to prevent azide build up 4 Human serum is not used in the preparation of this product however since human specimens will be used for samples and other quality control products in the lab may be derived from human serum please use standard laboratory safety procedures in handling all specimens and controls 5 Do not use beyond the expiration date 6 The ST AIA PACK CA19 9 has been designed so that the high dose hook effect is not a problem for the vast majority of samples Samples with CA 19 9 concentrations between 400 and 200 000 U mL will read gt 400 U mL The hook effect phenomenon may occur at CA 19 9 concentrations gt 200 000 U mL 7 TOSOH ATA 1200 series or AIA 600 Immunoassay Analyzers can NOT be used to perform the ST ATA PACK CA19 9 assay STORAGE AND STABILITY All unopened materials are stable until the expiration date on the label when stored at the specified temperature Materials Cat No 2 8 C ST AIA PACK CA19 9 0025271 AIA PACK CA19 9 CALIBRATOR SET 0020371 AIA PACK CA1
32. ristics 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 200 apparently healthy Asian subjects range 37 U mL Conversion Factors CA 19 9 concentrations in this application are in units of U mL Conversion to SI units of kU L may be made using the following equations kU CA 19 9 L U CA 19 9 mL x 1 0 PERFORMANCE CHARACTERISTICS ACCURACY a Recovery Two serum pools were spiked with three different levels of CA 19 9 and assayed before and after spiking Sample Initial CA19 9 Expected Measured Percent Value Added Value Value Recovery U mL U mL U mL U mL Serum Al 7 92 9 53 17 45 17 36 99 5 7 92 19 06 26 98 27 72 102 7 7 92 38 11 46 03 45 48 98 8 Serum B1 10 36 9 53 19 89 19 44 97 7 10 36 19 06 29 42 29 84 101 4 10 36 38 11 48 47 47 27 97 5 b Dilution Three serum samples containing high concentrations of CA 19 9 were serially diluted with AIA PACK CA19 9 SAMPLE DILUTING SOLUTION and assayed Sample Dilution Expected Measured Percent Factor Value Value Recovery U mL U mL Serum A2 none 341 0 7 5 10 255 7 254 8 99 6 5 0 10 170 5 176 8 103 7 2 5 10 85 2 92 1 108 0 1 0 10 34 1 35 6 104 3 Serum B2 none 349 2 75 10 261 9 267 4 102 1 5 0 10 174 6 182 3 104 4 2 5 10 87 3 94 6 108 3 1 0 10 34 9 35 8 102 4 Serum C
33. ults of other tests clinical impressions therapy etc Using ST AIA PACK CA19 9 the highest measurable concentration of CA 19 9 in specimens without dilution is 400 U mL and the lowest measurable concentration in specimens is 1 0 U mL assay sensitivity Although the approximate value of the highest calibrator is 420 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 400 U mL Although hemolysis has an insignificant effect on the assay hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution Lipemia has an insignificant effect on the assay except in the case of gross lipemia where spatial interference may occur Specimens from patients taking medicines and or medical treatment may show erroneous results Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti mouse antibodies HAMA Such specimens may show falsely elevated values when tested for CA 19 9 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 characte
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