Enzygnost* Anti-HBc monoclonal - Medcorp

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7. Samples from patients with circulating immune complexes as well as samples containinganti-mouse IgG were not observed to interfere with the test result.8. Samples containing antibodies to hepatitis A virus, EBV, HIV, HCV as well as lipaemic andicteric samples may exhibit elevated reactivity.9. Samples from haemodialysis patients, transplant patients, patients with multiple bloodtransfusions as well as from patients with raised transaminase values may exhibit elevatedreactivity.10. When using thawed samples, ensure good homogenization of the material prior to use.11. The pack contains a matched set of reagents. Reagents must not be interchanged with otherkits unless the reagents are from an identical lot (i.e. they must display the required 6-digit lotnumbers printed on the pack and given in the enclosed barcode table). Washing SolutionPOD, Stopping Solution POD and Working Chromogen Solution are exceptions to thisrequirement. Note that the Working Chromogen Solution must first be prepared frommatched components (do not use Chromogen TMB and Buffer/Substrat TMB from kits with adifferent number).12. Buffer/Substrate TMB, the Working Chromogen Solution and the Stopping Solution PODmust not be allowed to come into contact with heavy metal ions or oxidizing substances (donot use pipettes with metal parts in contact with the liquid!). Do not perform the substratereaction in the proximity of disinfectants containing hypochlorite. If the Working ChromogenSolution has spontaneously developed a blue colour before transferral into the test plate, thisindicates that the solution is contaminated; in such cases prepare a fresh solution in a cleancontainer. Skin contact with the above-mentioned solutions is to be avoided.13. The test plate should be protected from vibration during the incubation phase (e.g. placed ona secured floatation aid, or in a non-circulating water bath); the wells of the plate must be incontact with the thermostated water. If stabilizers are used to prevent microbialcontamination of the water, care must be taken that neither the surface of the test plate northe wells come into contact with these solutions since such contamination can lead tounspecific reactions.14. With highly reactive samples the dye may precipitate during the stopping reaction. This doesnot interfere with the photometric evaluation.15. The control sera have been prepared from native human sera. As a result, turbidity mayoccur but this has no effect on the test result.16. Dade Behring has validated use of these reagents on various analyzers to optimize productperformance and meet product specifications. User defined modifications are not supportedby Dade Behring as they may affect performance of the system and assay results. It is theresponsibility of the user to validate modifications to these instructions or use of the reagentson analyzers other than those included in Dade Behring Application Sheets or theseinstructions for use.17. Results of this test should always be interpreted in conjunction with the patient’s medicalhistory, clinical presentation and other findings.Specific Performance CharacteristicsSensitivity and SpecificityThe results for the sensitivity and specificity study are summarized in Tables 2+3 (in the Appendix).The sensitivity of the test was studied using a total of 1266 anti-HBc positive samples and theresults obtained were 96.9 to 100% (initial testing) and 97.5% (retest result). It cannot be ruledout that when the test is used on a large scale some samples may escape detection.The specificity of the test was studied using a total of 6116 anti-HBc negative blood donationsamples and the specificity results obtained were 99.2% (initial testing) and 99.6% (retestresult). Different values may be obtained depending on the group of samples used, variations inprocedure, etc.Current knowledge indicates that a positive result in the anti-HBc test is not a certain sign of HBVinfection, just as a negative test result does not reliably exclude HBV infection.OUWE G13 C0541 (879) CS/R 6
ReproducibilityThe results for intra-/inter-assay reproducibility are summarized in Table 4 (in the Appendix).For intra-assay reproducibility the coefficients of variation obtained were 3.9 to 13.6%. For interassayreproducibility the coefficients of variation obtained were 5.6 to 15.3%. These are typicaldata. Different values may however be obtained depending on variations in test procedure, etc.* Enzygnost is a registered trademark of Dade Behring Marburg GmbH in Germany and othercountries.BEP is a registered trademark of Dade Behring Marburg GmbH in the USA, in Germany andother countries.Boviserin is a registered Trademark of Aventis Behring.Dade Behring Marburg GmbH0197Emil-von-Behring-Str. 76D-35041 Marburgwww.dadebehring.comUSA Distributor:Dade Behring Inc.Newark, DE 19714 U.S.A.OUWE G13 C0541 (879) CS/R 7
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