Table 1

Tabulation of the validation studies run at the regional VAMC for reference

Test and media validations summary
Abbott RealTime SARS-CoV-2 Assay
Known Positive Samples Run	68
Known Negative Samples Run	59*
Precision Runs	4+and 4−samples daily over 5 days
Limit of Detection (LOD) Study	Three replicates each at 1000, 500, 250, 70, 60, and 50 virus copies/ml
	Seven replicates each at manufacturer LOD of 100 virus copies/ml
Cepheid Xpert Xpress SARS-CoV-2 Assay
Known Samples Locally Run on Day 1	2+and 2−samples
Known samples Locally Run on day 2	1+and 1−samples
Intrafacility Viral Transport Media Emergency Usage
Sterility	Two 3 mL aliquots to be cultured per 500 mL of Hanks Balanced Salt Solution Base
Initial Efficacy	Day 1: 3+and −samples refrigerated
	Day 2: 3+samples at room temperature, 3+samples in refrigerated, and 3 −samples refrigerated
	Day 3: 3+samples and 3 −samples refrigerated, 3+samples frozen at −20 C then thawed
Ongoing Efficacy	2+and 2 −samples per 500 mL of Hanks Balanced Salt Solution Base
Phosphate Buffered Saline Media Emergency usage
Abbott RealTime SARS-CoV-2 Assay	ten known samples after 6 hour incubation (half +/−)
	ten known samples after 12 hours incubation (half +/−)
	ten known samples after 24 hours incubation (half +/−)
	ten known samples after 48 hours incubation (half +/−)
Cepheid Xpert Xpress SARS-CoV-2 Assay	ten known samples after 6 hour incubation (half +/−)

All samples run for the validation reacted or had results as expected.
*One negative sample was quantity not sufficient, and so 58 known negative sample results were available for the validation.
−, negative; +, positive; VAMC, Veteran Affairs Medical Center.