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AMP reports findings of SARS-CoV-2 molecular testing survey

November 2020—In an Association for Molecular Pathology survey, 62 percent of U.S. labs reported using only commercial testing kits with FDA EUA for SARS-CoV-2 molecular testing. Five percent reported using laboratory-developed tests only, 26 percent said they were using a combination of LDTs and EUA commercial kits, and six percent reported using LDTs, IRB-approved/non-EUA assays, and commercial kits. Less than one percent reported using a combination of LDTs and IRB-approved/non-EUA assays or a combination of IRB-approved/non-EUA assays and commercial kits.

The survey took place from Aug. 13 to Sept. 11 and was open to AMP members and nonmembers. More than 100 responses came from U.S. labs.

Ninety-eight percent of U.S. respondents reported running SARS-CoV-2 diagnostic testing, 72 percent screening testing, and 29 percent surveillance testing. Labs had the option to choose all that apply.

The majority of respondents did not report experiencing significant numbers of false-negatives (87 percent) or false-positives (89 percent), but they indicated that the absence of a clinical gold standard and variability of testing platforms with regard to limits of detection presented analytical challenges.

To increase lab or hospital system capacity, 63 percent said (in selecting all that apply) that they plan to add more platforms or tests, 59 percent said they would add tests or test kits, and 62 percent said they would increase the lab workforce.

Sixty percent are running seven days per week at full staffing/test capacity to perform SARS-CoV-2 testing, but about 85 percent have experienced staff shortages. And supply chain problems continue, though the percentage of labs reporting shortages of swabs and viral transport media in an AMP survey conducted in April (67 percent for swabs and 62 percent for viral transport media) declined to 21 percent and 29 percent, respectively, in the August-September survey.

About 42 percent of the U.S. labs categorized their lab as an academic medical center lab, 26 percent as a commercial reference lab, 24 percent as a community hospital or health system lab, three percent as a public or state lab, and six percent selected other settings. The AMP says the survey had broad participation from across the U.S.

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