Accu-Tell^® HIV 1+2 ELISA KIT

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^® Anti-HIV 1+2 ELISA is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M - O) or type 2 in human serum or plasma samples. The assay can be utilized for screening of blood donors and/or 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

Evaluation study carried in Alkmaar, the Netherlands, between April and November 2005, demonstrated the following performance characteristics of ACCU-TELL® Anti-HIV 1+2 ELISA: The diagnostic specificity of the kit was 99.85% as determined on all negative samples (5471) that were investigated. When examined on the unselected donors only (random and first time donors), the specificity was 99.92% (95% CI 99.84-100%).

ACCU-TELL^® Anti-HIV 1+2 ELISA test results on unselected donors:

All panels of HIV-1, HIV-1 subtype O and HIV-2 confirmed antibody positive samples that were used in this study were also tested reactive with ACCU-TELL^® Anti-HIV 1+2 ELISA which resulted in diagnostic sensitivity of 100%.

A total of 32 seroconversion panels, which represent 210 samples tested. 13 samples not classified from PRB918 and PRB917 because there are not data of Antigen or RNA determination required for the classification. 41 samples classified as negative. RNA and or Antigen negative. 61 samples classified as early-seroconversion. 95 samples classified as seroconversion.

The testing results also show that ACCU-TELL^® Anti-HIV 1+2 ELISA is a state-of-the-art compare to most of the currently available on the market CE-marked tests.

The analytical sensitivity was evaluated on PeliCheck anti-HIV panels. The analytical sensitivity of ACCU-TELL^® Anti-HIV 1+2 ELISA on the PeliCheck anti-HIV standard dilutions was comparable to other anti-HIV assays.

Analytical specificity: ACCU-TELL^® Anti-HIV 1+2 ELISA test results on samples from hospitalized patients and samples containing potentially cross-reacting blood-specimens.

In a separate study, the following specificity results were obtained:

Possible high dose hook effect is eliminated due to the implementation of two-step procedure.

Frozen positive/negative specimens have been tested to check for interferences due to collection and storage. The performance characteristics of ACCU-TELL^® Anti-HIV 1+2 ELISA were not affected for at least 3 freeze/thaw cycles.

Samples from patents infected with hepatitis A, B, C as well as samples from patients infected with Treponema pallidum were tested with no cross-reactive reactions observed.

25 positive fresh serum samples tested in INSTITUTE FOR TROPICAL MEDICINE, BELGIUM have been tested with ACCU-TELL^® Anti-HIV 1+2 ELISA. All 25 positive fresh serum samples have been positive with ACCU-TELL^® Anti-HIV 1+2 ELISA.

Accuracy: The below tables represent the results of analytical sensitivity and reproducibility of ACCU-TELL^® Anti-HIV 1+2 ELISA as controlled with PeliSpyMulti-Marker run control and with QC sample tested in every plate - the 1:2048 dilution of the anti-HIV standard in this PeliSpy sample was consistently detected in all plates.

PeliSpyMulti-Marker results:

QC sample results:

Intra-batch variations:

Inter-batch variations:

Operator variations:

LIMITATIONS

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

2. Antibodies may be undetectable during the early stage of the disease and in some immunosuppressed individuals. Therefore, negative results obtained with ACCU-TELL^® Anti-HIV 1+2 ELISA are only indication that the sample does not contain detectable level of anti-HIV 1/2 antibodies 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.

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) plasma. ACCU-TELL^® Anti-HIV 1+2 ELISA has been evaluated only with individual serum or plasma specimens.

7. ACCU-TELL^® Anti-HIV 1+2 ELISA is a qualitative assay and the results cannot be use to measure antibodies concentrations. This assay cannot distinguish between infections with HIV-1 and HIV-2.

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