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.