Triangle Laboratory Validated Study for SARS-CoV-2 Positive Samples by Heat Inactivation

October 5, 2021

Triangle Laboratory Inc., a contract research organization (CRO), is the drug development company supporting comprehensive large molecule bioanalysis services. We recently developed and validated a pharmacokinetics study which requires to analyze samples with SARS-CoV-2 indication.

We followed the WHO procedure, “GENERAL PROCEDURES FOR INACTIVATION OF POTENTIALLY INFECTIOUS SAMPLES WITH EBOLA VIRUS AND OTHER HIGHLY PATHOGENIC VIRAL AGENTS,” and developed our own method in inactivating SARS-CoV-2 virus. We will be able to use this method in BSL-3 laboratories.

We spiked the test article into the human serum with final concentration of 0.2% of sodium dodecyl sulphate (SDS), 0.1% Tween 20, and underwent water bath heat inactivation at 60 for at least 30 minutes. The result showed that the test article was not significantly affected in % relative error and % coefficient of variation. This proves that the PK assay was not impacted by the SARS-CoV-2 inactivation process.

This procedure implies a general method for inactivating SARS-CoV-2 positive serum or other biomatrix samples.

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