Product Manual
14 60061-7 (2021-01) Accula SARS-CoV-2 IFU
E. Authorized laboratories must collect information on the performance of the test and report to DMD/OHT7-OIR/OPEQ/CDRH (via
email: CDRH-EUA-Reporting@fda.hhs.gov) and Mesa Biotech, Inc. Technical Support (via email: info@mesabiotech.com) any
suspected occurrence of false positive or false negative results and significant deviations from the established performance
characteristics of the test of which they have become aware.
F. All operators using your product must be appropriately trained in performing and interpreting the results of your product, use
appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling.
G. Mesa Biotech, its authorized distributors and authorized laboratories using the Accula SARS-CoV-2 Test must ensure that any
records associated with this EUA are maintained until otherwise notified by FDA. Such records must be made available to FDA for
inspection upon request.
1
The Letter of Authorization refers
U.S.C. §263a, to high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient
care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
PERFORMANCE CHARACTERISTICS
Limit of Detection (LoD)
LoD testing was performed with inactivated SARS-CoV-2 virus from BEI (NR-52350). The preliminary LoD was determined by testing 5
replicates with 2 fold dilutions. To confirm the LoD, dilutions were performed in pooled negative nasal swab human clinical matrix to
identify the concentration that produced at least 95% positive results. Confirmatory testing was performed using three lots of Accula
SARS-CoV-2 Test cassettes. Twenty (20) replicates from each cassette lot were tested with inactivated virus diluted in clinical matrix.
The LoD was confirmed to be 150 copies per mL.
Virus
LoD (Copies per mL)
Positive/Replicates (%)
SARS-CoV-2 Inactivated Virus (BEI)
150
58/60 (97%)
Analytical Reactivity/Inclusivity
Due to the limited availability of SARS-CoV-2 isolates for inclusivity testing, in silico analysis was employed to evaluate the extent of
homology between Accula SAR-CoV-2 primers and probes and all sequenced SARS-CoV-2 isolates from the United States available in
the GISAID database as of December 5, 2020. 35,556 sequences were examined to identify the extent of predicted assay inclusivity. The
table below summarizes the homology between 35,556 SARS-CoV-2 sequences and the Accula SARS-CoV-2 Test primers and probes.
The forward primer shares 100% homology with 29612 of the 35556 available sequences (83.3% of sequences with perfect match). 4552
SARS-CoV-the forward
primer (GGG->AAC) resulting in forward primer homology of 90.3% in these 4552 isolates. 99.5% of database sequences share a perfect
ll conserved at all
positions with greater than 97.8% of the database sequences sharing perfect homology with the reverse primer. 99.7% of databases
Amplicon detection in the Accula test cassette is accomplished through hybridization of amplicon to detection oligonucleotide conjugated
to dyed polystyrene microspheres and to capture oligonucleotide probes immobilized on the detection strip at discrete line positions to
generate a visible colorimetric signal. The detection probe is 100% homologous to 35435 of the 35556 database entries (99.7%) while the
capture probe is similarly well conserved sharing perfect homology with 35497 of the 35556 of the database entries (99.8%).
Table 1. In Silico Analysis of Inclusivity for the Accula SARS-CoV-2 Test
Oligonucleotide
Homology Description
N gene Forward Primer
29612 of 35556 complete SARS-CoV-2 genome sequences share 100% homology to
the Forward Primer.
35368 of 35556 complete SARS-CoV-2 genome sequences share 100% homology
4552 of 35556 complete SARS-CoV-2 genome sequences carry 3 mismatches (GGG-
gy. Laboratory