Enzygnost* Anti-HBs II - Medcorp

Limitations of the Procedure
1. Anticoagulants such as heparin, EDTA and citrate do not interfere with the test.
2. Samples that are lipaemic, haemolytic, icteric or contain rheumatoid factors do not impair the
test results.
3. In the case of samples from pregnant women, no interference with the test result was
observed.
4. Samples containing the following potential sources of interference were checked in the test:
HBs antigen, ANA as well as antibodies to HCV, HAV, HBC, HBe, EBV and CMV. With the
samples used, no interference was observed with the test result.
5. No interferences were observed with heat-treated samples (30 min, 56 °C).
6. Serum from insufficiently coagulated blood, contain sodium azide or microbial contamination
should not be used. Any particulate components in the sample (e.g. fibrin clots) should be
removed before the test.
7. When using thawed samples, ensure good homogenization of the material prior to use.
8. The pack contains a matched set of reagents. Reagents must not be interchanged with other
kits unless the reagents are from an identical lot (i.e. they must display the required 6-digit lot
numbers printed on the pack and given in the enclosed barcode table). Washing Solution
POD, Stopping Solution POD and Working Chromogen Solution are exceptions to this
requirement. Note that the Working Chromogen Solution must first be prepared from
matched components (do not use Chromogen TMB and Buffer/Substrat TMB from kits with a
different number).
9. Buffer/Substrate TMB, the Working Chromogen Solution and the Stopping Solution POD
must not be allowed to come into contact with heavy metal ions or oxidizing substances (do
not use pipettes with metal parts in contact with the liquid!). Do not perform the substrate
reaction in the proximity of disinfectants containing hypochlorite. If the Working Chromogen
Solution has spontaneously developed a blue colour before transferral into the test plate, this
indicates that the solution is contaminated; in such cases prepare a fresh solution in a clean
container. Skin contact with the above-mentioned solutions is to be avoided.
10. The control sera have been prepared from native human sera. As a result, turbidity may
occur but this has no effect on the test result.
11. The test plate should be protected from vibration during the incubation phase (e.g. placed on
a secured floatation aid, or in a non-circulating water bath); the wells of the plate must be in
contact with the thermostated water. If stabilizers are used to prevent microbial contamination
of the water, care must be taken that neither the surface of the test plate nor the wells come
into contact with these solutions since such contamination can lead to unspecific reactions.
12. With highly reactive samples the dye may precipitate during the stopping reaction. This does
not interfere with the photometric evaluation.
13. Dade Behring has validated use of these reagents on various analyzers to optimize product
performance and meet product specifications. User defined modifications are not supported
by Dade Behring as they may affect performance of the system and assay results. It is the
responsibility of the user to validate modifications to these instructions or use of the reagents
on analyzers other than those included in Dade Behring Application Sheets or these
instructions for use.
14. Results of this test should always be interpreted in conjunction with the patient’s medical
history, clinical presentation and other findings.
OQNE G11 C0541 (906) H/R 8