Table 1.
Key elements of a successful false-positive mitigation plan.
Elements | Corrective actions |
---|---|
Verify the source of false-positive(s) | Confirm SARS-CoV-2 genetic marker(s) via gel-electrophoresis and/or sequencing. Use appropriate controls (e.g., field negative, method negative, and no-template) to identify sample collection, processing where contaminant(s) is/are introduced. |
RT-PCR method step(s) where contaminant(s) is/are introduced. | |
Expunge contamination from the test environment | Use aseptic technique and properly disinfect/sterilize all sample collection equipment, devices, bottles, and other laboratory consumables. |
Discard all unsealed consumables and reagents throughout entire method. | |
Thoroughly clean all work area surfaces and equipment. | |
RT-PCR method updates (varies by source) |
Strict enforcement of unidirectional laboratory workflow and dedicated equipment practices. |
Implement additional contamination monitoring for responsible step. | |
Use different reagent lots. | |
Use customized reagents that minimize carryover amplification contamination such as UNG. | |
Additional analyst training. | |
Demonstrate absence of contamination | Use appropriate controls (e.g., field negative, method negative, and no template) to verify that contamination has been eliminated. |