NeuMoDx Molecular, a QIAGEN Company, CAPA-00527, NeuMoDx HIV-1 Quant Assay

In summary, NeuMoDx HIV-1 Quant Test Strip results are reported as standard in IU/ml. A conversion factor is then applied to convert the unit of measurement to copies/ml. The Assay Definition File (ADF) and lnstructions for Use ( IFU) for the NeuMoDx HIV-1 Quant Test Strip currently state a conversion factor of 0.26 (copies/lU), whereas the updated conversion factor is 0.75 (copies/lU). The updated conversion factor results in higher viral loads in copies/ml [0.46 10910 copies/ ml]. This brings the NeuMoDx HIV-1 Test Strip results in copies/ml closer aligned with other CE-IVD assays and External Quality Assurance (EQA)/Ring trial schemes. The change in conversion factor does not impact the analytica!