Clinical characteristics of hospitalized patients with false-negative severe acute respiratory coronavirus virus 2 (SARS-CoV-2) test results

Abstract

Objective: To determine clinical characteristics associated with false negative SARS-CoV-2 testing to help inform COVID-19 testing practices in the inpatient setting. Design: A retrospective observational cohort study. Setting: Tertiary care facility. Patients: All patients two years of age and older tested for SARS-CoV-2 between March 14, 2020 and April 30, 2020 who had at least two SARS-CoV-2 reverse-transcriptase polymerase chain reaction tests within seven days. Methods: The primary outcome measure was a false negative testing episode, which we defined as an initial negative test followed by a positive test within the subsequent seven days. Data collected included symptoms, demographics, comorbidities, vital signs, labs, and imaging studies. Logistic regression was used to model associations between clinical variables and false negative SARS-CoV-2 test results. Results: The 1,009 SARS-CoV-2 test results included in the analysis, 4.0% were false negative results. In multivariable regression analysis, compared to true negative test results, false negative test results were associated with anosmia/ageusia (aOR 8.4, 95% CI 1.4-50.5, p = 0.02), having a COVID-19 positive contact (aOR 10.5, 95% CI 4.3-25.4, p < 0.0001), and having an elevated lactate dehydrogenase level (aOR 3.3, 95% CI 1.2-9.3, p = 0.03). Demographics, symptom duration, other laboratory values, and abnormal chest imaging were not significantly associated with false negative test results in multivariable analysis. Conclusions: Clinical features can help predict which patients are more likely to have false negative SARS-CoV-2 tests.

Use of an innovation center to foster high‐value COVID‐19 care at an academic healthcare system

“…Of the initial 1009 SARS-CoV-2 test results analyzed, 4% were false-negatives. 21 implemented across select hospital units. Regardless of whether suggestions were ultimately implemented, sharing them gave leadership the opportunity to receive input from the front line, while giving the front line an opportunity to provide input to leadership.…”

Patient characteristics associated with conversion from negative to positive severe acute respiratory syndrome coronavirus‐2 polymerase chain reaction test results: Implications for clinical false‐negativity from a single‐center: A case‐control study

“…Finally, we did not control for exposures between test results thus we cannot distinguish between a conversion due to an initial false negative versus new infection. Many studies assessing the clinical sensitivity of the SARS‐CoV2 PCR used repeated tests within 7 days 7,11 . While our inclusion criteria allowed for testing up to 14 days apart, most patients had their repeat test within 9 days.…”

“…However, reported clinical sensitivity has ranged from 58% to 99% 2–4 . This wide range has been attributed to sample site, suboptimal sampling, timing of testing, and/or low viral loads 2,5–8 …”

“…2 , 3 , 4 This wide range has been attributed to sample site, suboptimal sampling, timing of testing, and/or low viral loads. 2 , 5 , 6 , 7 , 8 …”

“…[2][3][4] This wide range has been attributed to sample site, suboptimal sampling, timing of testing, and/or low viral loads. 2,[5][6][7][8] Some studies have evaluated the frequency of conversion from an initial negative to a later positive RT-PCR in patients who were repeatedly tested for SARS-CoV2. [9][10][11] These studies suggested that the timing of presentation, viral load, or test indication can be associated with conversion.…”