Table 10.

Performance characteristics of EUA assays used in testing donor NP specimens

Assay (manufacturer)	Sample type	Sensitivity	Specificity	Limit of detection (LOD)1
BioGX2 SARS-CoV-2 (Becton, Dickinson & Company)	NP Swab	19/19a positive at ~ 1–2 × LOD; 10/10 at ~ 3–5 × LOD	30/30 negative	40 genome equivalents (GE)/mL
Viracor3 SARS-CoV-2 (Viracor Eurofins Clinical Diagnostics)	NP Swab	20/20 positive at ~ 2 × LOD	30/30 negative	73 copies/mL
Procleix4 SARS-CoV-2 (Grifols)	NP Swab	Positive Percent Agreement: 30/30; 100% (95% CI: 88.65–100.00%)*	Negative Percent Agreement: 30/30; 100% (95% CI: 88.65–100.00%)*	60 copies/mL

^aDuring screening one retrospective nasopharyngeal swab clinical sample resulted in an UND for N1 and as a result was removed from data analysis

^*Two-sided 95% score confidence intervals

¹Lowest concentration of genomic RNA from SARS-CoV-2 that can be reproducibly distinguished from negative samples ≥ 95% of the time

²EUA data available via FDA at https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations and https://www.fda.gov/media/136653/download

³EUA data available via FDA at https://www.fda.gov/media/143069/download?attachment

⁴EUA data available via FDA at https://www.fda.gov/media/145938/download and additional information provided in Sauleda et al. (2022) and Bakkour (2021)

Table 10 provides performance information available at the time of testing for EUA assays used to test donor nasopharyngeal swabs for SARS-CoV-2.