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Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2.
Am J Clin Pathol. 2020 07 07; 154(2):201-207.AJ

Abstract

OBJECTIVES

To evaluate the clinical performance of 3 molecular assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

METHODS

We used 184 nasopharyngeal swab specimens to compare Abbott ID NOW COVID-19 (Abbott ID NOW), DiaSorin Molecular Simplexa COVID-19 Direct (DiaSorin Simplexa), and Roche cobas 6800 SARS-CoV-2 (Roche cobas) assays. In a separate analysis, 3 specimens (nasopharyngeal, oropharyngeal, and nasal) were collected from 182 unique patients presenting to the emergency department with suspicion of coronavirus disease 2019 and were tested utilizing Abbott ID NOW. To further characterize each assay, relative limits of detection were evaluated utilizing positive nasopharyngeal patient samples.

RESULTS

The positive percent agreement was 91% (95% confidence interval [CI], 0.76-0.97) for Abbott ID NOW and 100% (95% CI, 0.90-1.00) for DiaSorin Simplexa and Roche cobas. The negative percent agreement was 100% (95% CI, 0.98-1.00) for all 3 assays. All swab types tested with the Abbott assay produced concordant results. Polymerase chain reaction assays had approximately 10 to 100 times lower limits of detection than Abbott ID NOW.

CONCLUSIONS

Based on these evaluations, a multiplatform testing approach is proposed, depending on patient population and assay sensitivity, to address testing needs during a public health emergency.

Authors+Show Affiliations

OhioHealth Laboratory Services, Columbus. CORPath Pathology Services, Columbus, OH.OhioHealth Research Institute, Columbus.OhioHealth Laboratory Services, Columbus.OhioHealth Laboratory Services, Columbus.OhioHealth Laboratory Services, Columbus.OhioHealth Research Institute, Columbus.OhioHealth Laboratory Services, Columbus.OhioHealth Laboratory Services, Columbus.OhioHealth Laboratory Services, Columbus. CORPath Pathology Services, Columbus, OH.OhioHealth Laboratory Services, Columbus. CORPath Pathology Services, Columbus, OH.OhioHealth Laboratory Services, Columbus. CORPath Pathology Services, Columbus, OH.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32462195

Citation

Cradic, Kendall, et al. "Clinical Evaluation and Utilization of Multiple Molecular in Vitro Diagnostic Assays for the Detection of SARS-CoV-2." American Journal of Clinical Pathology, vol. 154, no. 2, 2020, pp. 201-207.
Cradic K, Lockhart M, Ozbolt P, et al. Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2. Am J Clin Pathol. 2020;154(2):201-207.
Cradic, K., Lockhart, M., Ozbolt, P., Fatica, L., Landon, L., Lieber, M., Yang, D., Swickard, J., Wongchaowart, N., Fuhrman, S., & Antonara, S. (2020). Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2. American Journal of Clinical Pathology, 154(2), 201-207. https://doi.org/10.1093/ajcp/aqaa097
Cradic K, et al. Clinical Evaluation and Utilization of Multiple Molecular in Vitro Diagnostic Assays for the Detection of SARS-CoV-2. Am J Clin Pathol. 2020 07 7;154(2):201-207. PubMed PMID: 32462195.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2. AU - Cradic,Kendall, AU - Lockhart,Marie, AU - Ozbolt,Patrick, AU - Fatica,Lisa, AU - Landon,Lorie, AU - Lieber,Michael, AU - Yang,David, AU - Swickard,Juanita, AU - Wongchaowart,Nicholas, AU - Fuhrman,Susan, AU - Antonara,Stella, PY - 2020/5/29/pubmed PY - 2020/7/18/medline PY - 2020/5/29/entrez KW - Abbott ID NOW KW - COVID-19 KW - Coronavirus KW - Molecular diagnostics KW - SARS-CoV-2 SP - 201 EP - 207 JF - American journal of clinical pathology JO - Am J Clin Pathol VL - 154 IS - 2 N2 - OBJECTIVES: To evaluate the clinical performance of 3 molecular assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We used 184 nasopharyngeal swab specimens to compare Abbott ID NOW COVID-19 (Abbott ID NOW), DiaSorin Molecular Simplexa COVID-19 Direct (DiaSorin Simplexa), and Roche cobas 6800 SARS-CoV-2 (Roche cobas) assays. In a separate analysis, 3 specimens (nasopharyngeal, oropharyngeal, and nasal) were collected from 182 unique patients presenting to the emergency department with suspicion of coronavirus disease 2019 and were tested utilizing Abbott ID NOW. To further characterize each assay, relative limits of detection were evaluated utilizing positive nasopharyngeal patient samples. RESULTS: The positive percent agreement was 91% (95% confidence interval [CI], 0.76-0.97) for Abbott ID NOW and 100% (95% CI, 0.90-1.00) for DiaSorin Simplexa and Roche cobas. The negative percent agreement was 100% (95% CI, 0.98-1.00) for all 3 assays. All swab types tested with the Abbott assay produced concordant results. Polymerase chain reaction assays had approximately 10 to 100 times lower limits of detection than Abbott ID NOW. CONCLUSIONS: Based on these evaluations, a multiplatform testing approach is proposed, depending on patient population and assay sensitivity, to address testing needs during a public health emergency. SN - 1943-7722 UR - https://www.unboundmedicine.com/medline/citation/32462195/Clinical_Evaluation_and_Utilization_of_Multiple_Molecular_In_Vitro_Diagnostic_Assays_for_the_Detection_of_SARS_CoV_2_ L2 - https://academic.oup.com/ajcp/article-lookup/doi/10.1093/ajcp/aqaa097 DB - PRIME DP - Unbound Medicine ER -