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Objectives: At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention-developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.Methods: The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.Results: Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.Conclusions: Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results. [ABSTRACT FROM AUTHOR]

Background: This study assesses proficiency test (PT) performance in detecting and identifying malaria parasites and examines malaria screening practices in laboratories in the United States. Method: We reviewed PT data from 1999 to 2008 to determine the rates of unacceptable responses for detecting and identifying Plasmodium sp. We also surveyed current PT participants to assess malaria screening practices. Results: Laboratories were most proficient at detecting and identifying P falciparum and substantially less proficient at identifying P malariae, P vivax, and P ovale. Half of the surveyed laboratories failed to offer a complete diagnostic workup, 25.0% failed to screen both thick and thin slides, and 36.1% failed to issue a final report within 24 hours. Conclusion: Educational programs should focus on identifying Plasmodium sp. and distinguishing artifacts from parasites. Laboratories should offer a complete diagnostic workup, either in-house or by referral, and ensure final results within 24 hours. [ABSTRACT FROM AUTHOR]