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. 2022 Apr 16;54(4):472–478. doi: 10.1016/j.pathol.2022.01.006

Table 2.

Grading of results for rounds 1, 2 and 3 of the SARS-CoV-2 proficiency testing program

Round RCPAQAP
Sample ID
Concordant Discordant Not assessed
1 (Mar 2020) S1 SARS-CoV-2 positive SARS-CoV-2 negative
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
S2 SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive
N/A SARS-CoV-2 negative (recorded either SARS-CoV-2 N or E genes detected)
Invalid
Not tested
S3 SARS-CoV-2 negative SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
S4 SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive
SARS-CoV-2 negative (recorded either SARS-CoV-2 N or E genes not detected) Invalid
Not tested
S5 SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive
SARS-CoV-2 negative (recorded either SARS-CoV-2 N or E genes not detected) Invalid
Not tested
2 (May 2020) S6 SARS-CoV-2 positive SARS-CoV-2 negative
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
S7 SARS-CoV-2 positive SARS-CoV-2 negative
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
S8 SARS-CoV-2 presumptive positive
Inconclusive
SARS-CoV-2 positive SARS-CoV-2 negative
Invalid
Not tested
S9 SARS-CoV-2 negative SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
S10 SARS-CoV-2 positive SARS-CoV-2 negative
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
3 (Nov 2020) S11 SARS-CoV-2 negative SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive (automated result generated by NAT assay)a
Invalid
Not tested
S12 SARS-CoV-2 negative SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive (automated result generated by NAT assay)a
Invalid
Not tested
S13 SARS-CoV-2 negative SARS-CoV-2 positive
SARS-CoV-2 presumptive positive
Inconclusive (automated result generated by NAT assay)a
Invalid
Not tested
S14 SARS-CoV-2 positive SARS-CoV-2 negative
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested
S15 SARS-CoV-2 positive SARS-CoV-2 negative
SARS-CoV-2 presumptive positive
Inconclusive
Invalid
Not tested

a Inconclusive and invalid results reported by participants were based on a nucleic acid test (NAT) assay that included an internal control, i.e., tested for the presence of RNaseP. The lack of RNaseP target resulted in an inconclusive or invalid result. These results were either manually interpreted by the participant or reported as unresolved by the system. Other participants using similar assays had disregarded the results for the RNaseP while acknowledging the potential of inadequate or lack of human cellular material in a proficiency testing material. Some participants who performed testing on the BD MAX platform commented that while the automated result generated by the system of the platform was invalid, their submitted results were manually interpreted and reported as SARS-CoV-2 negative as the system requires the presence of RNase-P in the survey specimen to automatically interpret the results.