Table 2.
Interpretation of Results for Patient Samples Based on Data from the One-Step Multiplex Assay
| N | S | ORF1ab | MS2 | Results Interpretation | Report | Follow-Up Action |
|---|---|---|---|---|---|---|
| − | − | − | − | Invalid | INVALID | the result is reported into the EMR as such and it is recommended that a new sample is obtained from the patient |
| If two or more targets are detected (2/2 technical replicates detected for each) | +/− | SARS-CoV-2 detected | POSITIVE | report into EMR | ||
| − | − | − | + | SARS-CoV-2 not detected | NEGATIVE | report into EMR |
| If signal is detected but only one target reaches 2/2 detected technical replicates | +/− | inconclusive | INCONCLUSIVE | sample is repeated at qRT-PCR step once more. If sample is still inconclusive, the result is reported into the EMR as such and it is recommended that a new sample is obtained from the patient | ||
| If signal is detected in >1 disparate targets, but none reaches 2/2 detected technical replicates | +/− | SARS-CoV-2 detected | POSITIVE | report into EMR | ||