NEWS
We work according to the European norms [01.10.2005]
For the purposes of harmonization of requirements to produced products
with European Norms defined in Directive 98/79/EC on in vitro
diagnostic medical devices during 2003-2005 there were successfully
accomplished evaluation trials for performance characteristics of
DIA-HIV ½ test kit manufactured by JSC Diaproph-Med in leading
reference centers of Europe – Institute of tropical Medicine
(Antwerp, Belgium), Paul-Ehrlich-Institute (Langen, Germany). Today for
DIA-HIV ½ test kit all requirements to performance tests in
accordance with Common Technical Specifications (Directive 98/79/EC)
are met for ELISA test kits for HIV/AIDS diagnostics. Generalized data
of clinical trials for DIA-HIV ½ test kit and use in blood donor
services for 1999-2005 are shown in Table 1.
Complete History of Evaluation of DIA-HIV 1/2 test kit.
Table 1
| Requirements in accordance with Common Technical Specifications (Directive 98/79/ЕС) |
Obtained data of clinical trials for DIA-HIV ½ (number of investigated samples / panels) |
Sensitivity
|
Specificity
|
| Characteristics |
Sample type |
Required number of samples / panels |
| Diagnostic Sensitivity |
Positive samples |
400 HIV 1
100 HIV 2
40 non B-subtype |
873
132
30 |
100%
100%
100% |
N/A
N/A
N/A |
| Seroconversion panels |
20 panels
10 further panels |
37 |
criteria are acceptable for 3rd generation ELISA |
|
| Specificity |
Unselected donors |
5000 |
2 891 094 |
N/A |
99.56 % |
| Hospitalized patients |
200 |
375 |
N/A |
100% |
| Potentially cross-reacting blood- specimens (RF+, related viruses, pregnant women etc.) |
100 |
23432 |
N/A |
97.97-99.3% |
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