ESfEQA MOLECULAR DIAGNOSTICS PROGRAMS

MOLECULAR DIAGNOSTICS PROGRAMS

HBV MOLECULAR

Program: HBVM: 4 surveys/year x 3 samples

Material: Lyophilized samples of human serum. Virus positive samples contain the whole genome of inactivated HBV (minimum 1 mL)

Evaluation: Qualitative and quantitative

This program is not accredited according to DIN EN ISO/ IEC 17043.

Analytical parameters:

HBV-DNA (qualitative and quantitative)

HCV MOLECULAR

Program: HCVM: 4 surveys/year x 3 samples

Material: Lyophilized samples of human serum. Virus positive samples contain the whole genome of

inactivated HCV (minimum 1 mL)

Evaluation: Qualitative and quantitative

This program is not accredited according to DIN EN ISO/ IEC 17043.

Analytical parameters:

HCV-RNA (qualitative and quantitative)

HIV MOLECULAR

Program: HIVM: 4 surveys/year x 3 samples

Material: Lyophilized samples of human serum. Virus positive samples contain the whole genome of inactivated HIV (minimum 1 mL)

Evaluation: Qualitative and quantitative

This program is not accredited according to DIN EN ISO/ IEC 17043.

Analytical parameters:

HIV-RNA (qualitative and quantitative)

SARS-COV-2 MOLECULAR

Program: COVM: 4 surveys/year x 3 samples

Material: Liquid or lyophilized samples containing human epithel cells or fibroblasts as control for positive nucleic acid extraction and amplification. Virus-positive samples contain the whole genome of inactivated SARS-CoV-2, thus covering all possible gene targets used in different NAT/PCR assays (minimum 1 mL).

Evaluation: Qualitativ and quantitative*

Analytical parameters:

SARS-CoV-2 RNA (qualitative)

General detection as well as reporting per gene target

SARS-CoV-2 RNA (quantitative)

General indication as well as reporting of quantitative value per gene target

* The quantitative parameters are not accredited according to DIN EN ISO/ IEC 17043