Clinical Performance of the Point-of-Care cobas Liat for Detection of SARS-CoV-2 in 20 Minutes: a Multicenter Study
| Autor: | John Rodrigo, Alan Huang, Zi Xuan Wang, Kylie Labog, Joanna Sickler, Lars F. Westblade, Sachin K. Garg, Kathleen G. Beavis, Glen Hansen, Karen Ding, Run Jin, Nedra Love, Jamie Marino, Nam K. Tran |
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| Přispěvatelé: | McAdam, Alexander J |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Time Factors
viruses Medical and Health Sciences cobas Liat SARS-CoV-2 and influenza A/B Nasopharynx Infection control skin and connective tissue diseases Lung screening and diagnosis medicine.diagnostic_test Clinical performance virus diseases Biological Sciences Detection Infectious Diseases point-of-care (POC) COVID-19 Nucleic Acid Testing Pneumonia & Influenza coronavirus disease 2019 (COVID-19) Infection Microbiology (medical) medicine.medical_specialty Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Point-of-Care Systems reverse transcription-polymerase chain reaction Microbiology Vaccine Related coronavirus disease 2019 Ambulatory care Clinical Research Virology Biodefense medicine Humans cobas 68/8800 SARS-CoV-2 Point of care Agricultural and Veterinary Sciences business.industry SARS-CoV-2 Prevention fungi Nucleic acid test COVID-19 Gold standard (test) Pneumonia United States Liat 4.1 Discovery and preclinical testing of markers and technologies body regions Emerging Infectious Diseases point-of-care reverse transcription-polymerase chain reaction (RT-PCR) Emergency medicine business |
| Zdroj: | Journal of Clinical Microbiology Journal of clinical microbiology, vol 59, iss 2 |
| ISSN: | 1098-660X 0095-1137 |
| DOI: | 10.1128/jcm.02811-20 |
| Popis: | Highly accurate testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the point of care (POC) is an unmet diagnostic need in emergency care and time-sensitive outpatient care settings. Reverse transcription-PCR (RT-PCR) technology is the gold standard for SARS-CoV-2 diagnostics. Highly accurate testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the point of care (POC) is an unmet diagnostic need in emergency care and time-sensitive outpatient care settings. Reverse transcription-PCR (RT-PCR) technology is the gold standard for SARS-CoV-2 diagnostics. We performed a multisite U.S. study comparing the clinical performance of the first U.S. Food and Drug Administration (FDA)-authorized POC RT-PCR for detection of SARS-CoV-2 in 20 min, the cobas Liat SARS-CoV-2 and influenza A/B nucleic acid test, to the most widely used RT-PCR laboratory test, the cobas 68/8800 SARS-CoV-2 test. Clinical nasopharyngeal swab specimens from 444 patients with 357 evaluable specimens at five U.S. clinical laboratories were enrolled from 21 September 2020 to 23 October 2020. The overall agreement between the Liat and 68/8800 systems for SARS-CoV-2 diagnostics was 98.6% (352/357). Using Liat, positive percent agreement for SARS-CoV-2 was 100% (162/162) and the negative percent agreement was 97.4% (190/195). The Liat is an RT-PCR POC test that provides highly accurate SARS-CoV-2 results in 20 min with performance equivalent to that of high-throughput laboratory molecular testing. Rapid RT-PCR testing at the POC can enable more timely infection control and individual care decisions for coronavirus disease 2019. |
| Databáze: | OpenAIRE |
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