VIDAS® Anti-HCV - ILEX Medical Systems
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1. TN 10249 49002 A 03 9385501 rerun ra a www ilexmedical com sales ilexmedical com 03 9385500 Op9 HEPATITIS C mA y VIDAS Designed to last VIDAS a Customized Solution for your Daily Workload Ease of use Load and Go Robustness MTBF gt 700 days Routine Testing High Quality tests for reliable diagnosis Up to 10 parameters in one run Cost effective solution Comprehensive panels Thyroid Fertility Cardiac Markers Single dose Tumor Markers HIV Hepatitis TORC All inclusive kits Convenient packaging size Complementary and Specialized Testing e Confirmatory testing HIV DUO Toxo Avidity DD Exclusion Prolactin VIDAS and mini VIDAS Specialized testing Lyme Measles Mumps H pylori CD A B Chl ia Allergy The adapted offer to your organization A Complementary Testing large menu gt 90 parameters Emergency Testing e 24 7 available Rapid results in compliance with Healthcare guidelines Emergency panel TNIU CK MB Myoglobin NT proBNP DD Exclusion PCT Digoxin hCG VIDAS ANTI HCV For Clear and Confident Diagnosis of Hepatitis C 1EAN Ln a rane ag swt Mil m am bioM rieux S A 69280 Marcy l Etoile France Tel 33 0 4 78 87 20 00 Fax 33 0 4 78 87 20 90 BIOME RIEUX www biomerieux com www biomerieux diagnostics com BIOME RIEUX2. 1 LAVANCHY D Evolving epidemiology of hepatitis C virus Clin Microbiol Infect 2011 17 107 115 2 ALTER MJ Epidemiology of hepatitis C virus infection World J Gastroenterol 2007 13 17 2436 2441 3 GURTSEVITCH VE Human Oncogenic Viruses Hepatitis B and Hepatitis C Viruses and Their Role in Hepatocarcinogenesis Biochemistry Moscow 2008 73 5 504 513 4 SIMMONDS P et al Consensus Proposals for a Unified System of Nomenclature of Hepatitis C Virus Genotypes HEPATOLOGY 2005 42 962 973 5 VERMEHREN J SARRAZIN C New HCV therapies on the horizon Clin Microbiol Infect 2011 17 122 134 6 WEBSTER D P KLENERMAN P COLLIER J JEFFERY K JM Development of novel treatments for hepatitis C Lancet Infect Dis 2009 9 108 17 7 CHEVALIEZ S Virological tools to diagnose and monitor hepatitis C virus infection Clin Microbiol Infect 2011 17 116 121 8 PENIN F DUBUISSON REY F A MORADPOUR D ET PAWLOTSKY JM Structural Biology of Hepatitis C Virus HEPATOLOGY 2004 39 5 19 9 THIO CL NOLT KR ASTEMBORSKI J VLAHOV D NELSON KE et THOMAS DL Screening for Hepatitis C Virus in Human Immunodeficiency Virus Infected Individuals Journal of clinical microbiology Feb 2000 38 2 575 577 BIOMERIEUX the blue logo VIDAS and SPR are used pending and or registered trademarks belonging to bioM rieux SA or one of its subsidiaries CLSI is a trademark belonging to Clinical and Laboratory Standards Insti
3. history the clinical record and further tests A negative test result does not exclude the possibility of exposure to HCV or infection with HCV Anti HCV antibodies may be undetectable in some stages of the infection acute phase of hepatitis or presence of a serological scar and in some clinical conditions immunosuppression 7 9 Interference may be encountered with certain sera containing antibodies against reagent components This test has not been validated for use with any specimen matrices other than human serum or plasma RANGE OF EXPECTED VALUES 1 Hepatitis C has a worldwide prevalence of 2 3 that varies according to country Anti HCV prevalence Europe 2 3 Region of the world Africa Diagnostic sensitivity observed 95 confidence interval 100 Population Positive VIDAS Anti HCV total tested HCV HIV negative patient 254 254 98 56 100 98 36 91 20 99 96 100 97 07 100 99 77 438 439 98 74 99 99 The patient who was not detected using VIDAS Anti HCV either had a low antibody level or was not detected using equivalent methods HCV HIV positive patient 60 61 Patient with unknown 124 124 HCV HIV status Total HCV population 4 Sensitivity for seroconversion panels Testing of 30 seroconversion panels demonstrated the precocity of detection of the VIDAS Anti HCV assay The results are comparable to those obtained using the most sensitive me
4. recent infection antigens are used for the qualitative detection of anti HCV VIDAS HAV IgM VIDAS HBs Ag Ultra antibodies serum or plasma Increase in transaminase levels i e Ultra sensitivity to e Detects all 6 HCV genotypes Control of previous Immunity or vaccination Reduce the serological windows e For patients with clinical symptoms or at risk populations VIDAS Anti HAV Total Highlight hidden infections VIDAS Anti HCV ose el nar With all the benefits of VIDAS Detection Core NS3 NS4 IgG 5 ati Easy to use Principle Sandwich ELFA are aU mL Robust and reliable system VIDAS HEPATITIS PANEL Can be used in treatment follow up and as an indicator of a Kit size THE FLEXIBILITY YOU NEED viral reactivation ena ey m e Cost effective 60 test packaging Calibration Every 28 days Follow up of Chronic Hepatitis Ideal for routine complementary or specialized testing Saas ae we VIDAS HBs Ag Ultra ns VIDAS HAV IgM 30 tests ref 30 307 VIDAS HBe Anti HBe Result interpretation lt 1 negative 306 f P P t y 2 ti i 6 t gt 1 00 positive VIDAS Anti HAV tota 30 se rer 50 512 re or Fost Vaccination Immunity Control 2 Total Crick VIDAS quality you can trust Hepatitis B e CV lt 5 around the cut off of 10 IU ml VIDAS HBs Ag Ultra ref 30 315 VIDAS Anti HBc Total Il The solid performance of the VIDAS Anti HCV assay in clinical imeti Excellent sensitivity provide
5. 03 12 9303110 008 GB A This document is not legally binding bioM rieux reserves the right to modify specifications without notice BIOMERIEUX the blue logo and VIDAS are used pending and or registered trademarks belonging to bioM rieux S A or one of its subsidiaries bioM rieux SA RCS Lyon 673 602 399 Photos Getty Images GraphicObsession Fotolia Norbertj Printed in France THERA Conseil RCS Lyon B 398 160 2 kao Hepatitis Testing Viral hepatitis is a major global healthcare problem responsible for significant morbidity and socio economic losses with an estimated 3 of the world s population infected with HCV alone The VIDAS hepatitis panel now covers all the must have parameters for differential diagnosis of HAV HBV and HCV so you can provide Adjusted treatment Better patient management Rapid results Hepatitis A Hepatitis B VIDAS anti HCV to support you H titi C 5 ii ti 5 TES In hepatitis C investigations Total anti HBc Ab ATT 709 gt The VIDAS Anti HCV assay combines a two step enzyme Incubation Acute phase Incubation Acute phase Convalescence Incubation Acute phase Convalescence 4 7 weeks 4 12 weeks 2 7 weeks several days 2 weeks 3 8 months 4 12 weeks 2 12 weeks 2 16 weeks Immunoassay sandwich method with a final fluorescent isIE detection Proprietary recombinant Core NS3 and NS4 HCV RNA Diagnosis of recent infection Diagnosis of
6. 1 HCV Negative control 1 x 1 9 ml liquid mention Control C2 Test Value Range Standard 1 x 1 9 ml liquid Pooled human serum or plasma containing anti HCV IgG in a phosphate buffer BSA preservatives The confidence interval in Relative Fluorescence Value RFV is indicated on the MLE card after the following mention Standard S1 RFV Range 1 MLE card Master Lot Entry Specifications for the factory master data required to calibrate the test to read the MLE data please refer to the User s Manual 1 Package Insert provided in the kit or downloadable from www biomerieux com techlib This product has been tested and shown to be negative for HBs surface antigen and antibodies to HIV1 and HIV2 The product has been inactivated However since no existing test method can totally guarantee their absence this product must be treated as potentially infectious Therefore usual safety procedures should be observed when handling The Strip The strip consists of 10 wells covered with a labeled foil seal The label comprises a bar code which mainly indicates the assay code kit lot number and expiration date The foil of the first well is perforated to facilitate the introduction of the sample The last well of each strip is a The SPR The interior of the SPR is coated during production with the antigens representing the HCV core NS3 and NS4 proteins Each SPR is identified by the code HCV Only remove the re
7. G sample No disease related interference was observed for VIDAS Anti HCV VIDAS Anti HCV HVB HBcT HVB Ag HBs Syphilis Rubella IgG The reference EIA method also showed one false positive sample but on a different sample including 10 multipara bioMerieux SA English 6 9300913 6 en 2012 01 INDEX OF SYMBOLS Catalogue number In Vitro Diagnostic Medical Device Manufacturer Temperature limitation mnie mi LOT Batch code Consult Instructions for Use Contains sufficient for lt n gt tests WARRANTY bioM rieux disclaims all warranties express or implied including any implied warranties of MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE bioM rieux Shall not be liable for any incidental or consequential damages IN NO EVENT SHALL BIOMERIEUX S LIABLITY TO CUSTOMER UNDER ANY CLAIM EXCEED A REFUND OF THE AMOUNT PAID BIOMERIEUX FOR THE PRODUCT OR SERVICE WHICH IS THE SUBJECT OF THE CLAIM VIDAS Anti HCV HCV WASTE DISPOSAL Dispose of used or unused reagents as well as any other contaminated disposable materials following procedures for infectious or potentially infectious products It is the responsibility of each laboratory to handle waste and effluents produced according to their nature and degree of hazardousness and to treat and dispose of them or have them treated and disposed of in accordance with any applicable regulations REFERENCES BIBLIOGRAPHIQUES
8. IDAS PTC protocol read the MLE data again Before each new lot of reagents is used specifications or factory master calibration data must be entered into the instrument using the MLE data If this operation is not performed before initiating the tests the instrument will not be able to print results The master lot data need only be entered once for each lot It is possible to enter MLE data manually or automatically depending on the instrument refer to the User s Manual Calibration Calibration using the standard provided in the kit must be performed upon receipt of a new lot of reagents after the master lot data have been entered Calibration should then be performed every 28 days This operation provides instrument specific calibration curves and compensates for possible minor variations in assay signal throughout the shelf life of the kit The standard identified by 51 must be tested in duplicate see User s Manual The standard value must be within the set RFV Relative Fluorescence Value range If this is not the case recalibrate Procedure 1 Only remove the required reagents from the refrigerator They can be used immediately 2 Use one HCV strip and one HCV SPR for each sample control or standard to be tested Make sure the storage pouch has been carefully resealed after the required SPRs have been removed 3 The test is identified by the HCV code on the instrument The standard must be id
9. TCU UUIXNU 0 gt ex Medical Ltd 17 2012 bioMerieux mann Vidas Anti HCV win Vidas Anti HCV Hepatatis C Virus Generation 3 3 HCV Ag Nucleocapsid CORE e NS3 NS4 IgG 8 IgM Ao voon e e HBsAg HBc IgM amp lgG HBe Anti HBe Anti HBs B AntiHCV Co vvoon e 28 ul 100 Ready To Use 51 01 lt 1 Negative 21 Positive ARON gt 5 30308 VIDAS ANTI HCV 60 TESTS bioMerieux mann 054 5686303 054 6686183 7
10. V HCV MATERIALS AND DISPOSABLES REQUIRED BUT NOT PROVIDED Pipette with disposable tip to dispense 100 ul Powderless disposable gloves For other specific materials and disposables please refer to the Instrument User s Manual Instrument of the VIDAS family WARNINGS AND PRECAUTIONS e For in vitro diagnostic use only e For professional use only e This kit contains products of human origin No known analysis method can totally guarantee the absence of transmissible pathogenic agents It is therefore recommended that these products be treated as potentially infectious and handled observing the usual safety precautions see Laboratory biosafety manual WHO Geneva Latest edition This kit contains products of animal origin Certified knowledge of the origin and or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents It is therefore recommended that these products be treated as potentially infectious and handled observing the usual safety precautions do not ingest or inhale Do not use the SPR s if the pouch is pierced Do not use visibly deteriorated STRs damaged foil or plastic Do not use reagents after the expiration date indicated on the box label Do not mix reagents or disposables from different lots Use powderless gloves as powder has been reported to cause false results for certain enzyme immunoassay tests Kit reagents contain sodium azide whic
11. d strips from the instrument 11 Dispose of the used SPRs and strips appropriate recipient RESULTS AND INTERPRETATION Once the assay is completed results are analyzed automatically by the computer Fluorescence is measured twice in the Reagent Strip s reading cuvette for each sample tested The first reading is a background reading of the substrate cuvette before the SPR is introduced into the substrate The second reading is taken after incubating the substrate with the enzyme remaining on the interior of the SPR The RFV Relative Fluorescence Value is calculated by subtracting the background reading from the final result This calculation appears on the result sheet The results are automatically calculated by the instrument The patient RFV is interpreted as follows Test value patient RFV standard RFV This test value and the interpretation are also included on the result sheet The interpretation depending on the test value is as follows Interpretation Test value TV negative lt 1 00 positive All positive patient results must be verified in duplicate If at least one of the repeat values is positive the patient result is considered as positive In that case additional tests should be performed another immunoassay or HCV marker on the same sample or on a second one into an Note In all cases refer to current national guidelines concerning HCV diagnosis Interpretation of VIDAS Anti HCV test r
12. d with the inhibition technique trials confirms the high level of quality you ve come to oss E ey expect from VIDAS for your peace of mind and the patient s Diagnostic Sensitivity 95 Confidence Interval HCV HIV negative patients 100 Screening during Pregnancy ae pepe DON VIDAS Anti HBc Total 60 tests ref 30 4 se Uta Diagnostic Specificity 95 Confidence Interval b 91 Payee Blood donor population 99 61 HCV HIV unknown patients 100 Clinical Specificity 95 Confidence Interval Total population 99 77 n 439 98 74 99 99 99 50 97 25 99 99 Hospitalized patients n 200 Hepatitis C 1 patient who was not detected using VIDAS Anti HCV either had a low antibody level or was not VIDAS Anti HCV ref 30 308 detected using equivalent method REF 30 308 9300913 0 en 2012 01 ED VIDAS Anti HCV HCV VIDAS Anti HCV is an automated qualitative test for use on the instruments of the VIDAS family for the detection of IgG antibodies to hepatitis C virus anti HCV in human serum or plasma heparin using the ELFA technique Enzyme Linked Fluorescent Assay The detection of these specific antibodies in conjunction with other clinical information aids in the diagnosis of infection in persons with symptoms of hepatitis and in persons at risk for hepatitis C infection The VIDAS Anti HCV assay is a third generation test using antigens correspondin
13. entified by S1 and tested in duplicate If the positive control is to be tested it should be identified by C1 If the negative control is to be tested it should be identified by C2 4 If necessary clarify samples by centrifugation 5 Mix the standard controls and samples using a vortex type mixer for serum or plasma separated from the pellet 7 Insert the HCV SPRs and the HCV strips into the instrument Check to make sure the color labels with the assay code on the SPRs and the Reagent Strips match 8 Initiate the assay as directed in the User s Manual All the assay steps are performed automatically by the instrument bioM rieux SA 9300913 6 en 2012 01 2 Clinical specificity for hospitalized patients 200 samples with a negative status were tested using the VIDAS Anti HCV assay Diagnostic specificity of the VIDAS Anti HCV assay on this population 99 50 95 confidence interval 97 25 99 99 3 Diagnostic sensitivity 439 samples with a positive status including 102 fresh samples collected lt 24 hours previously were tested using the VIDAS Anti HCV assay Genotypes 1 to 6 were tested Genotype Number tested ee nn 21 22 non a sub types Results on tested populations VIDAS Anti HCV HCV LIMITATIONS OF THE METHOD For the diagnosis of HCV infection the serological results should be used and interpreted taking into account the patient
14. esults should be made taking into consideration the patient history and the results of any other tests or hepatitis C markers QUALITY CONTROL One positive control and one negative control are included in each VIDAS Anti HCV kit These controls must be performed immediately after opening a new kit to ensure that reagent performance has not been altered Each calibration must also be checked using these controls The instrument will only be able to check the control values if they are identified by C1 and C2 Results cannot be validated if the control values deviate from the expected values Note It is the responsibility of the user to perform Quality Control in accordance with any local applicable regulations English 4 4100 VIDAS Anti HCV HCV INSTRUCTIONS FOR USE For complete instructions see the User s Manual VIDAS PTC protocol data entry When using the assay for the first time and before reading the MLE data scan the bar code s at the end of the package insert using the instrument s external bar code reader This reading will allow VIDAS PTC protocol data to be transferred to the instrument software for its update These data should only be read the first time the assay is used Master lot data entry Note When using the assay for the first time enter the VIDAS PTC protocol bar codes at the end of the package insert before reading the MLE data If the MLE data have been read before the V
15. g to the HCV core NS3 and NS4 proteins for the qualitative detection of anti HCV antibodies PRINCIPLE The assay principle combines a two step enzyme immunoassay sandwich method with a final fluorescent detection ELFA The Solid Phase Receptacle SPR serves as the solid phase as well as the pipetting device Reagents for the assay are ready to use and are pre dispensed in the sealed reagent strips All of the assay steps are performed automatically by the instrument The reaction medium is cycled in and out of the SPR several times During the first step the sample is diluted and then cycled in and out of the SPR several times The anti HCV antibodies present in the sample will bind to the antigens representing the HCV core NS3 and NS4 proteins coated on the interior of the SPR Unbound sample components are washed away During the second step mouse monoclonal anti human IgG antibodies in Fab form conjugated to recombinant alkaline phosphatase yeast are cycled in and out of the SPR several times and will bind to the human Ig bound to the molecules on the solid phase Further wash steps remove unbound components During the final detection step the substrate 4 Methyl umbelliferyl phosphate is cycled in and out of the SPR The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product 4 Methyl umbelliferone the fluorescence of which is measured at 450 nm The intensity of the fluorescence
16. h can react with lead or copper plumbing to form explosive metal azides any liquid containing sodium azide is disposed of in the plumbing system drains should be flushed with water to avoid build up The substrate in well 10 contains an irritant agent 6 6 diethanolamine Refer to the risk phrase R and the precautions S above Spills should be wiped up thoroughly after treatment with liquid detergent or a solution of household bleach containing at least 0 5 sodium hypochlorite See the User s Manual for cleaning spills on or in the instrument Do not autoclave solutions containing bleach e The instrument should be regularly cleaned and decontaminated see the User s Manual STORAGE CONDITIONS e Store the VIDAS Anti HCV kit at 2 8 C e Do not freeze reagents e Store all unused reagents at 2 8 C e After opening the kit check that the SPR pouch is correctly sealed and undamaged If not do not use the SPRs e To maintain stability of the remaining SPRs carefully reseal the pouch after use with the desiccant inside and return the complete kit to 2 8 C e f stored according to the recommended conditions all components are stable until the expiration date indicated on the label bioM rieux SA 9300913 6 en 2012 01 9 Restopper the vials and return them to 2 8 C after pipetting 10 The assay will be completed within approximately 40 minutes After the assay is completed remove the SPRs an
17. ion tubes may contain materials and additives that could generate different test results It is the responsibility of each laboratory to validate use of these tubes in accordance with the manufacturer s recommendations for use Specimen preparation Plain tubes wait for samples to coagulate and centrifuge according to the tube manufacturer s recommendations to eliminate fibrin Other tubes follow recommendations for use Frozen stored samples after thawing these samples must be homogenized before analysis Sample related interference None of the following factors have been found to significantly influence this assay hemolysis after spiking samples with hemoglobin 0 to 300 mol l monomer lipemia after spiking samples with lipids 0 to 30 mmol l equivalent in triglycerides bilirubinemia after spiking samples with bilirubin 0 to 220 mg ml or 376 mol l However it is recommended not to use samples that are clearly hemolyzed lipemic or icteric and if possible to collect a new sample Do not inactivate samples Specimen stability Serum and plasma samples separated from the clot can be stored at 2 8 C in stoppered tubes for 7 days if longer storage is required freeze the sera or plasma at 25 6 C Do not exceed 3 freeze thaw cycles A study performed on samples frozen for 12 months showed that the quality of results is not affected the tube manufacturer s English 3 VIDAS Anti HC
18. is proportional to the concentration of antibody present in the sample At the end of the assay the results are automatically calculated by the instrument in relation to the Standard 1 stored in memory and then printed out English 1 SUMMARY AND EXPLANATION The Hepatitis C virus HCV discovered in 1989 using advanced molecular biology techniques was rapidly found to account for the majority of those patients with non A non B hepatitis HCV represents a major worldwide public health problem requiring global action for the diagnosis treatment and prevention of this infection 1 HCV is primarily parenterally transmitted through direct blood to blood contact between two people use of unsterilized injection devices and transfusion of unscreened blood or blood products 2 The disease frequently progresses to chronic hepatitis C 80 exposing patients to a greater risk of hepatic complications such as cirrhosis or hepatocellular carcinoma 3 The current standard of treatment for HCV is a combination of two drugs pegylated interferon and ribavirin but due to the high genetic variability of HCV 4 it is still only partially effective viral eradication in less than 50 of patients infected with genotype 1 hepatitis C virus against approximately 80 of patients infected with genotype 2 or 3 New therapeutic options are under study to offer more effective and safer personalized treatments 5 6 Diagnosis of patients infected w
19. ith HCV can be performed using two categories of virological tests indirect tests and direct tests 7 Indirect serological tests are third generation enzyme immunoassays that detect antibodies to HCV The antigens used in the tests to detect antibodies are from the structural and non structural regions of the HCV 8 capsid protein cofactors polymerase etc The presence of anti HCV antibodies indicates that an individual may have been infected with HCV in the past or may have an ongoing HCV infection To confirm the presence of active HCV infection a positive serological test can be completed using direct tests e g molecular assays that detect RNA genomes The results will be used to guide patient management and determine the optimal duration of treatment bioM rieux SA VIDAS Anti HCV HCV 9300913 C en 2012 01 CONTENT OF THE KIT 60 TESTS RECONSTITUTION OF REAGENTS 60 Strips HCV SIR Ready to use 60 SPRs HCV Ready to use 2 x 30 Interior of SPRs coated with antigens representing the HCV core NS3 and NS4 proteins HCV Positive control 1 x 1 9 ml liquid Pooled human serum or plasma containing anti HCV IgG in a phosphate buffer BSA preservatives Index The confidence interval is indicated on the MLE card after the following mention Control C1 Test Value Range C2 Phosphate buffer BSA preservatives Index The confidence interval is indicated on the MLE card after the following S
20. quired number of SPRs from the pouch and carefully reseal the pouch after opening cuvette in which the fluorometric reading is performed The wells in the center section of the strip contain the various reagents required for the assay Description of the HCV strip Wash buffer TRIS buffered saline Tween 20 preservatives 600 ul Conjugate mouse monoclonal anti human IgG antibodies conjugated to recombinant ALP in Phosphate buffered saline protein stabilizer preservatives 400 ul Reactive diluent Phosphate buffered saline preservative 400 ul Reading cuvette with substrate 4 Methyl umbelliferyl phosphate 0 6 mmol l diethanolamine DEA 0 62 mol l or 6 6 pH 9 2 1 g l sodium azide 300 ul IRRITANT reagent R36 Irritating to eyes S 26 In case of contact with eyes rinse immediately with plenty of water and seek medical advice For further information refer to the Safety Data Sheet available on request bioM rieux SA English 2 9300913 6 en 2012 01 SPECIMENS Specimen type and collection Human serum or plasma Types of tubes validated Plain tube Tube with lithium heparin Tube with sodium heparin Tube with lithium heparin and separation gel Plastic tube with clot activator Plastic tube with clot activator and separation gel The use of heat inactivated sera has not been validate Note Depending on the manufacturer blood collect
21. thods English 5 PERFORMANCE The following study results demonstrate the conformity of VIDAS Anti HCV to the Common Technical Specifications of 98 79 CE Directive 1 Specificity for blood donor population 5104 blood donor samples including 2904 fresh samples with a negative status collected lt 24 hours previously obtained from 2 blood transfusion centers were tested using the VIDAS Anti HCV assay a Kl Negative 5084 Diagnostic 6 of the VIDAS assay on this population 99 61 95 confidence interval 99 40 99 76 bioM rieux SA VIDAS Anti HCV HCV 9300913 C en 2012 01 5 Precision The repeatability and reproducibility were determined at two sites and calculated according to the recommendations of the CLSI documents EP5 A2 EP12 A2 Four human samples were tested in duplicate using two lots of reagents Testing was performed twice a day for 10 days on three instruments at one experimental site N 120 Each reagent lot used a single calibration curve throughout the study Data from this study are summarized in the following table Target value Fini ae om as oo ae ome ar 6 Cross reactivity 273 samples from patients with a physiological status that can potentially interfere with the detection of hepatitis C antibodies were tested using VIDAS Anti HCV All of the samples were found to be negative with another EIA method except one CMV Ig
22. tute Inc RCS LYON 673 620 399 Tel 33 0 4 78 87 20 00 Fax 33 0 4 78 87 20 90 www biomerieux com C Eaa Any other name or trademark is the property of its respective owner bioM rieux SA D M X Chemin de l Orme 69280 Marcy l Etoile France
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