Product Manual

60061-7 (2021-01) Accula SARS-CoV-2 IFU 21
Testing of Clinical Samples
Retrospective Specimen Study
Fifty (50) retrospective clinical specimens, which had already been tested with a EUA authorized SARS-CoV-2 Real-Time RT-PCR Assay
were tested with the Accula SARS-CoV-2 Test. Each specimen was diluted in the minimum amount of Accula SARS-CoV-2 Buffer
required to obtain a valid Accula test result (presence of a control line), as VTM can inhibit the assay. Required dilutions ranged from 1:6
to 1:40. Test results are summarized in the table below. One test result was discordant (negative Accula/positive by the comparator). This
specimen was re-tested with the Comparator assay and also tested with a second EUA RT-PCR test. The specimen gave negative results
in both tests.
Accula
SARS-CoV-2 Test
Comparator Assay
Positive
Negative
Total
Positive
23
0
23
Negative
1*
26
27
Total
24
26
50
Positive Percent Agreement (PPA)
95.8% (95% CI: 78.88%  99.89%)
Negative Percent Agreement (NPA)
100% (95% CI: 86.77% - 100%)
Overall Percent Agreement (OPA)
98.0% (95% CI: 89.35% - 99.95%)
*1 negative discordant sample was not detected with a secondary comparator test or in re-test with the primary comparator.
Prospective Clinical Study
A prospective study was performed with 52 nasal swabs collected from pediatric patients at a drive-through collection site. Testing was
performed with the Accula SARS-CoV-2 test and the comparator method, a EUA authorized RT-PCR SARS-CoV-2 test. Test results are
summarized in the table below.
Accula
SARS-CoV-2 Test
Comparator Assay
Positive
Negative
Total
Positive
4
0
4
Negative
0
48
48
Total
4
48
52
Positive Percent Agreement (PPA)
100% (95% CI: 39.76% - 100%)
Negative Percent Agreement (NPA)
100% (95% CI: 92.60% - 100%)
Overall Percent Agreement (OPA)
100% (95% CI: 93.15% - 100%)
ASSISTANCE AND CONTACT INFORMATION
For technical questions or assistance, or if the Accula Dock and/or Accula SARS-CoV-2 Test is not performing as expected, please
contact Mesa Biotech at [e-mail] or [phone].