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Review
. 2022 Jun;42(2):223-236.
doi: 10.1016/j.cll.2022.03.002. Epub 2022 Mar 4.

Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2

Affiliations
Review

Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2

Nicole V Tolan et al. Clin Lab Med. 2022 Jun.

Abstract

Laboratories faced many challenges throughout the COVID-19 pandemic. Point-of-care (POC) SARS-CoV-2 nucleic acid amplification tests (NAATs) provided a key solution to the need for rapid turnaround time in select patient populations and were implemented at the POC but also within laboratories to supplement traditional molecular assays. Clinical Laboratory Improvement Amendments-waived rapid POC SARS-CoV-2 NAATs offer the benefit of reduced educational requirements for operators and can be performed by non-laboratory-trained individuals. However, these methods must be validated to ensure the manufacturer's performance specifications are met and they are found to be fit-for-purpose in the clinical workflows they are implemented.

Keywords: COVID-19 pandemic; Method validation; Point-of-care testing; Rapid nucleic acid amplification tests (NAATs); SARS-CoV-2 molecular assays.

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Figures

Fig. 1
Fig. 1
Comparison of the mechanism of (A) traditional RT-PCR requiring 3 to 5 hours and thermocycling equipment to (B) RT-LAMP technology requiring 10 to 60 minutes performed isothermally. (A) Author’s Original; (B) Adapted from Huang et al with permission from Frontiers in Microbiology (2018).
Fig. 2
Fig. 2
SARS-CoV-2 LIAT accuracy validation against the traditional Panther Fusion and Cepheid GeneXpert NAAT methods for (A) qualitative and (B) quantitative reporting of cycle time (Ct value).
Fig. 3
Fig. 3
Analytical sensitivity determination using (A) a standard with known viral copy numbers (SeraCare: 5663 copies/mL) and (BD) three sets of real patient samples as compared to the estimated copy numbers determined by a highly-sensitive reference method, Abbott m2000, for 3 SARS-CoV-2 NAAT methods. The limit of detection is shown for each method by the dashed vertical line.
Fig. 4
Fig. 4
Comparison of SARS-CoV-2 laboratory-based testing with the POC workflow. Traditional laboratory-based workflows typically incur delays from (1) sample transport, (2) batch delays, and (3) longer analytical time as compared with POC workflows requiring less than 60 minutes and are highly dependent on analytical assay time, which is much shorter.
Fig. 5
Fig. 5
Daily test volume and median TAT (from receipt in laboratory to result) for the laboratory-based Abbott Alinity method (2-hour analytical time, used for outpatient and inpatient/ED) and Cepheid/LIAT POCT assays performed at Tufts Medical Center. TAT goals were established as: Alinity outpatient: ≤6 hours; Alinity inpatient/ED: ≤4 hours; and Cepheid/LIAT: ≤1 hour.

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References

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