Product Manual

20 60061-7 (2021-01) Accula SARS-CoV-2 IFU
together in a vial of Accula SARS-CoV-2 Buffer. Positive samples were prepared from these thirty negative samples. Positive samples
were spiked with SARS-CoV-2 RNA (SARS-CoV-2 RNA/strain USA_WA1/2020) at the concentrations shown in the table below.
Samples were randomized, de-identified and blinded to the testing operator. Sample concentration and test results are summarized in the
table below. 100% agreement was observed with expected results.
Accula SARS-CoV-2 Evaluation with Throat/Nasal Swab Samples
Sample Concentration
N
Percent (%) Agreement with
Expected Results
(Observed/Expected)
2x LoD
20
100 (20/20)
5x LoD
7
100 (7/7)
10x LoD
2
100 (2/2)
50x LoD
1
100 (1/1)
Negative
30
100 (30/30)