Accu-Tell^® HIV 1+2 Ag/Ab ELISA KIT (4th generation)

Product Description

CATALOG

SUMMARY OF THE MAJOR COMPONENTS OF THE KIT

Use this summary only as a reference and always follow the comprehensive method sheet when performing the assay. Note: the components of individual kits are not lot- interchangeable.

SUMMARY OF THE ASSAY PROCEDURE

Use this summary only as a reference and always follow the detailed method sheet when performing the assay.

INTENDED USE

ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of antigens and/or antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M - O) and/or type 2 in human serum or plasma samples. The method is also known as 4th generation ELISA for HIV detection. The kit is intended for screening of blood donors and as an aid in the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2 - the etiological agents of the acquired immunodeficiency syndrome (AIDS).

PERFORMANCE CHARACTERISTICS

In a performance evaluation study, ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT demonstrated sensitivity in detection of HIV infection of 100%. The demonstrated specificity was of 99.76%.

Multi-center performance evaluation study was organized to access the performance characteristics of ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT demonstrated sensitivity in detection of HIV infection of 100%. The demonstrated specificity was of 99.75%.

The performance characteristics of ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT were compared with three other commercially available kits for the detection of HIV antibodies or HIV antigen and antibodies. Overall agreement of 99.89-100% was demonstrated.

After testing of more than 15000 negative and 700 HIV positive samples, the specificity of ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT was calculated as over 99.80%, and the demonstrated sensitivity was 100%.

No cross reactivity was observed with specimens from patients infected with HAV, HCV, HBV, HTLV, CMV and TP. No high dose hook effect and rheumatoid factor interference observed during clinical testing.

The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein.

Frozen specimens have been tested to check for interferences due to collection and storage.

LIMITATIONS

1. Positive results must be confirmed with another available method and interpreted in conjunction with the patient clinical information.

2. Antibodies or p24 antigen may be undetectable during the early stage of the disease and in some immunosuppressed individuals. Therefore, negative results obtained with ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT are only indication that the sample does not contain detectable level of HIV 1/2 antibodies or p24 antigen and any negative result should not be considered as conclusive evidence that the individual is not infected with HIV 1/2 or the blood unit is not infected with HIV 1/2.

3. If, after retesting of the initially reactive samples, the assay results are negative, these samples should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive ELISA assays, false positive results can occur due to the several reasons, most of which are related but not limited to inadequate washing step. For more information regarding ELISA Troubleshooting, please refer to ACCU-TELL’s ―ELISAs and Troubleshooting Guide‖, or contact technical support for further assistance.

4. The most common assay mistakes are: using kits beyond the expiry date, bad washing procedures, contaminated reagents, incorrect assay procedure steps, insufficient aspiration during washing, failure to add specimens or reagents, improper operation with the laboratory equipment, timing errors, the use of highly hemolyzed specimens or specimens containing fibrin, incompletely clotted serum specimens.

5. The prevalence of the marker will affect the assay’s predictive values.

6. This assay cannot be utilized to test pooled (mixed) serum or plasma. ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT has been evaluated only with individual serum or plasma specimens.

7. ACCU-TELL^® HIV 1+2 Ag/Ab ELISA KIT is a qualitative assay and the results cannot be used to measure antibody or antigen concentration. This assay cannot distinguish between infections with HIV-1 and HIV-2. This assay cannot distinguish between positive antibody and positive p24 antigen results.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.