PCR Molecular Testing

Nasal or Oropharyngeal swab collection; tested using PCR kit from Thermo Fisher (Life Technologies) TaqPath COVID-19 Combo kit EUA approved and CDC IDT kit for COVID 19.

Vitae tests for ORF1 ab, N gene and S gene for COVID virus.

Our specificity is claimed to be 100% and the sensitivity for this test based on our validation is 5 copies per microliter as lower limit of detection.

Instruments:  Thermo Fisher ABI 7500 FastDX

                 Thermo Fisher Quantstudio


First Molecular Sample Analyzed            03/06/2020

Anti-Body Testing

Serum collection; tested using ELISA kits from EPITOPE diagnostics with an EUA submission in March 2020.

The sensitivity of the kits is 100% according the manufacturer claim, specificity according to WHO study was 91% for IgG and 97% for IgM.

First Serology Sample Analyzed                  03/02/2020