96T

serum, plasma

Human

This 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).

The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of this anti-HIV 1+2 ELISA, during storage, protect the reagents from contamination with microorganism or chemicals.

Evaluation study carried in Alkmaar, the Netherlands, between April and November 2005, demonstrated the following performance characteristics of this 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%).

This 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 this 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 this 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 this anti-HIV 1+2 ELISA on the PeliCheck anti-HIV standard dilutions was comparable to other anti-HIV assays.
Analytical specificity: this 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 this 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 this anti-HIV 1+2 ELISA. All 25 positive fresh serum samples have been positive with this anti-HIV 1+2 ELISA.

Accuracy: The below tables represent the results of analytical sensitivity and reproducibility of this 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. QC sample was always detected in all plates.

Serological evidence of infection with HIV may be obtained by testing for presence of HIV antigens or antibodies in serum of individuals suspected for HIV infection. Antigen can generally be detected during both acute phase and the symptomatic phase of AIDS only. The antibodies to HIV-1 and/or HIV-2 can be detected throughout virtually the whole infection period, starting at or shortly after the acute phase and lasting till the end stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HIV infection. Apart from sexual transmission, the principal route of infection with HIV is blood transfusion. HIV can present both in cellular and cell-free fractions of human blood. Therefore, all donations of blood or plasma should be tested due to the risk of HIV transmission through contaminated blood. This can be effectively achieved by testing for the antibodies to HIV-1 and HIV-2 by using a highly sensitive ELISA tests.