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Occurrence and Timing of Subsequent Severe Acute Respiratory Syndrome Coronavirus 2 Reverse-transcription Polymerase Chain Reaction Positivity Among Initially Negative Patients
- Source :
- medRxiv, Clinical Infectious Diseases, Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
- Publication Year :
- 2020
-
Abstract
- BackgroundSARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) testing remains the cornerstone of laboratory-based identification of patients with COVID-19. As the availability and speed of SARS-CoV-2 testing platforms improve, results are increasingly relied upon to inform critical decisions related to therapy, use of personal protective equipment, and workforce readiness. However, early reports of RT-PCR test performance have left clinicians and the public with concerns regarding the reliability of this predominant testing modality and the interpretation of negative results. In this work, two independent research teams report the frequency of discordant SARS-CoV-2 test results among initially negative, repeatedly tested patients in regions of the United States with early community transmission and access to testing.MethodsAll patients at the University of Washington (UW) and Stanford Health Care undergoing initial testing by nasopharyngeal (NP) swab between March 2nd and April 7th, 2020 were included. SARS-CoV-2 RT-PCR was performed targeting the N, RdRp, S, and E genes and ORF1ab, using a combination of Emergency Use Authorization laboratory-developed tests and commercial assays. Results through April 14th were extracted to allow for a complete 7-day observation period and an additional day for reporting.ResultsA total of 23,126 SARS-CoV-2 RT-PCR tests (10,583 UW, 12,543 Stanford) were performed in 20,912 eligible patients (8,977 UW, 11,935 Stanford) undergoing initial testing by NP swab; 626 initially test-negative patients were re-tested within 7 days. Among this group, repeat testing within 7 days yielded a positive result in 3.5% (4.3% UW, 2.8% Stanford) of cases, suggesting an initial false negative RT-PCR result; the majority (96.5%) of patients with an initial negative result who warranted reevaluation for any reason remained negative on all subsequent tests performed within this window.ConclusionsTwo independent research teams report the similar finding that, among initially negative patients subjected to repeat SARS-CoV-2 RT-PCR testing, the occurrence of a newly positive result within 7 days is uncommon. These observations suggest that false negative results at the time of initial presentation do occur, but potentially at a lower frequency than is currently believed. Although it is not possible to infer the clinical sensitivity of NP SARS-CoV-2 RT-PCR testing using these data, they may be used in combination with other reports to guide the use and interpretation of this common testing modality.
- Subjects :
- 0301 basic medicine
Microbiology (medical)
medicine.medical_specialty
Emergency Use Authorization
2019-20 coronavirus outbreak
Repeat testing
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
030106 microbiology
medicine.disease_cause
Real-Time Polymerase Chain Reaction
Article
law.invention
03 medical and health sciences
0302 clinical medicine
COVID-19 Testing
law
Internal medicine
Medicine
Humans
030212 general & internal medicine
SARS-CoV-2 RT-PCR
Polymerase chain reaction
Independent research
Coronavirus
biology
business.industry
Reverse Transcriptase Polymerase Chain Reaction
SARS-CoV-2
Brief Report
nasopharyngeal
COVID-19
biology.organism_classification
Virology
testing
Test (assessment)
3. Good health
AcademicSubjects/MED00290
test characteristics
Infectious Diseases
Real-time polymerase chain reaction
Test performance
business
030217 neurology & neurosurgery
Betacoronavirus
Coronavirus Infections
Healthcare system
Subjects
Details
- ISSN :
- 15376591
- Volume :
- 72
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
- Accession number :
- edsair.doi.dedup.....876e8bac4b95277634847772ff7ca704