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Siemens Healthineers to collaborate with CDC to define threshold for NAb sufficient to confer immunity

October 2020—Siemens Healthineers will collaborate with the Centers for Disease Control and Prevention and the Joint Research Centre of the European Commission on a research project to develop a novel process for standardizing SARS-CoV-2 assays.

Comparing test results across manufacturers has not been possible, and thus establishing immunity associated with SARS-CoV-2 assays has been challenging.

The collaboration will produce a novel process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralizing antibody titer. The thresholds displayed in the standardized unit of measure for IgG—arising from natural infection or vaccination—may likely contribute to a standardized interpretation of immunity through test results.

“One barrier to antibody test adoption is we don’t currently have an established process to determine immunity,” Deepak Nath, PhD, president of laboratory diagnostics, Siemens Healthineers, said in a Sept. 15 statement. “Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity.”

Siemens Healthineers will collaborate with the CDC and JRC to “develop the framework,” he said, “that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves.”

Developing a standardized process will define which concentration confers neutralization for different manufacturers’ antigen targets. Each manufacturer now standardizes its assays independently with internal standards not linked to a common reference. The results of the collaborative research project will support the JRC’s production of a reference material, which, with assigned concentrations of antibody specific to each viral protein, will allow manufacturers to refer to standardized values.

FDA approves HIV-1/HIV-2 Qualitative, expanded use of CINtec Plus Cytology

The Food and Drug Administration approved Roche’s Cobas HIV-1/HIV-2 Qualitative test for use on the Cobas 6800/8800 systems in the United States. The test provides a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2.

The FDA also approved the expanded use of CINtec Plus Cytology and cleared the Cobas BKV test.

The Cobas HIV-1/HIV-2 Qualitative test is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of HIV-1 and HIV-2 RNA in human serum and plasma.

The CINtec Plus Cytology test detects the simultaneous presence within a single cell of p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, pro­gress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease.