Diagnostic Performance of an Antigen Test with RT-PCR for the Detection of SARS-CoV-2 in a Hospital Setting — Los Angeles County, California, June–August 2020

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Brihn, Auguste ; Chang, Jamie ; OYong, Kelsey ; Balter, Sharon ; Terashita, Dawn ; Rubin, Zach ; Yeganeh, Nava
• Description:
  Prompt and accurate detection of SARS-CoV-2, the Virus that causes COVID-19, has been important during public health responses for containing the spread of COVID-19, including in hospital settings (1-3). In vitro diagnostic nucleic acid amplification tests (NAAT), such as real-time reverse transcription-polymerase chain reaction (RT-PCR) can be expensive, have relatively long turnaround times, and require experienced laboratory personnel.* Antigen detection tests can be rapidly and more easily performed and are less expensive. The performance| of antigen detection tests, compared with that of NAATs, is an area of interest for the rapid Diagnosis of SARS-CoV-2 infection. The Quidel Sofia 2 SARS Antigen Fluorescent Immunoassay (FIA) (Quidel Corporation) received Food and Drug Administration Emergency Use Authorization for use in symptomatic patients within 5 days of symptom onset (4). The reported test positive percentage agreement| between this test and an RT-PCR test result is 96.7% (95% confidence interval [CI] = 83.3%-99.4%), and the negative percentage agreement is 100.0% (95% CI = 97.9%-100.0%) in symptomatic patients.| However, performance in asymptomatic persons in a university setting has shown lower sensitivity (5); assessment of performance in a clinical setting is ongoing. Data collected during June 30-August 31, 2020, were analyzed to compare antigen test performance with that of RT-PCR in a hospital setting. Among 1,732 paired samples from asymptomatic patients, the antigen test sensitivity was 60.5%, and specificity was 99.5% when compared with RT-PCR. Among 307 symptomatic persons, sensitivity and specificity were 72.1% and 98.7%, respectively. Health care providers must remain aware of the lower sensitivity of this test among asymptomatic and symptomatic persons and consider confirmatory NAAT tTesting in high-prevalence settings because a false-negative result might lead to failures in infection control and Prevention practices and cause delays in Diagnosis, isolation, and treatment.
• Subjects:
  Adolescent Adult Aged Aged, 80 And Over Antigens, Viral CoronaVirus Infections COVID-19 COVID-19 Nucleic Acid Testing Cross Infection Female Hospitals Humans Male Middle Aged SARS-CoV-2 Sensitivity And Specificity Young Adult

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• Source:
  MMWR Morbidity Mortal Weekly Rep. 70(19):702-706
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  33983916
• Pubmed Central ID:
  PMC8118154
• Document Type:
  Journal Article
• Place as Subject:
  Los Angeles, CA
• Pages in Document:
  5 pdf pages
• Volume:
  70
• Issue:
  19
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:404ff7d2ee266861583af0295712d03ddea11cdb18c061385d7790a3852a02f447e9b33e9a57c6228287bad07bc7fc58b4304b773507dd0d76ad66527481ac76
• Download URL:
  https://stacks.cdc.gov/view/cdc/106667/cdc_106667_DS1.pdf
• File Type:
  [PDF - 1004.81 KB ]