How quickly are results of a coronavirus disease 2019 (COVID-19) diagnostic test returned?

Updated: Apr 02, 2021
  • Author: James J Dunn, PhD, D(ABMM), MT(ASCP); more...
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Answer

Many NAATs require off-board nucleic acid extraction prior to RT-PCR testing. The use of magnetic particle technologies that bind nucleic acid has allowed automation of this process, [42] and this in turn has led to the development of many high-throughput nucleic acid extraction devices that can accommodate a large number of patient samples at one time. NAATs that require nucleic acid extraction should be performed using the appropriate instrument(s) in the EUA submission and manufacturer’s IFU.

An important factor that may influence the choice of NAATs for patient testing is the speed with which the assay can detect SARS-CoV-2 RNA. Some assays can return results in as few as 5-10 minutes, although more commonly the turnaround time is an hour or more. Assays that require external nucleic acid extraction will be inherently slower. Conversely, assays that do not require prior nucleic acid extraction and can be performed with minimal hands-on time (ie, sample to answer) generally offer a much shorter time to results, though there can still be considerable variation between assays. Some of these NAATs can be performed at the point of care in patient care settings operating under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. [43]  In some situations, when a specimen must be sent to a reference laboratory for testing, the turnaround time for results make take 2 days or more [44] .


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