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Cited by 76COVID-19 Clinical Research StudiesSARS-CoV-2 detection and testingSARS-CoV-2 and COVID-19 Research

Routine laboratory testing to determine if a patient has COVID-19

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Stegeman, Inge, Ochodo, Eleanor A, Guleid, Fatuma, Holtman, Gea A., Yang, Bada, Davenport, Clare, Deeks, Jonathan J, Dinnes, Jacqueline +11 more·2020·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd013787PMC PMC8078159
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Abstract

BACKGROUND: Specific diagnostic tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and resulting COVID-19 disease are not always available and take time to obtain results. Routine laboratory markers such as white blood cell count, measures of anticoagulation, C-reactive protein (CRP) and procalcitonin, are used to assess the clinical status of a patient. These laboratory tests may be useful for the triage of people with potential COVID-19 to prioritize them for different levels of treatment, especially in situations where time and resources are limited. OBJECTIVES: To assess the diagnostic accuracy of routine laboratory testing as a triage test to determine if a person has COVID-19. SEARCH METHODS: On 4 May 2020 we undertook electronic searches in the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern, which is updated daily with published articles from PubMed and Embase and with preprints from medRxiv and bioRxiv. In addition, we checked repositories of COVID-19 publications. We did not apply any language restrictions. SELECTION CRITERIA: We included both case-control designs and consecutive series of patients that assessed the diagnostic accuracy of routine laboratory testing as a triage test to determine if a person has COVID-19. The reference standard could be reverse transcriptase polymerase chain reaction (RT-PCR) alone; RT-PCR plus clinical expertise or and imaging; repeated RT-PCR several days apart or from different samples; WHO and other case definitions; and any other reference standard used by the study authors. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from each included study. They also assessed the methodological quality of the studies, using QUADAS-2. We used the 'NLMIXED' procedure in SAS 9.4 for the hierarchical summary receiver operating characteristic (HSROC) meta-analyses of tests for which we included four or more studies. To facilitate interpretation of results, for each meta-analysis we estimated summary sensitivity at the points on the SROC curve that corresponded to the median and interquartile range boundaries of specificities in the included studies. MAIN RESULTS: We included 21 studies in this review, including 14,126 COVID-19 patients and 56,585 non-COVID-19 patients in total. Studies evaluated a total of 67 different laboratory tests. Although we were interested in the diagnotic accuracy of routine tests for COVID-19, the included studies used detection of SARS-CoV-2 infection through RT-PCR as reference standard. There was considerable heterogeneity between tests, threshold values and the settings in which they were applied. For some tests a positive result was defined as a decrease compared to normal vaues, for other tests a positive result was defined as an increase, and for some tests both increase and decrease may have indicated test positivity. None of the studies had either low risk of bias on all domains or low concerns for applicability for all domains. Only three of the tests evaluated had a summary sensitivity and specificity over 50%. These were: increase in interleukin-6, increase in C-reactive protein and lymphocyte count decrease. Blood count Eleven studies evaluated a decrease in white blood cell count, with a median specificity of 93% and a summary sensitivity of 25% (95% CI 8.0% to 27%; very low-certainty evidence). The 15 studies that evaluated an increase in white blood cell count had a lower median specificity and a lower corresponding sensitivity. Four studies evaluated a decrease in neutrophil count. Their median specificity was 93%, corresponding to a summary sensitivity of 10% (95% CI 1.0% to 56%; low-certainty evidence). The 11 studies that evaluated an increase in neutrophil count had a lower median specificity and a lower corresponding sensitivity. The summary sensitivity of an increase in neutrophil percentage (4 studies) was 59% (95% CI 1.0% to 100%) at median specificity (38%; very low-certainty evidence). The summary sensitivity of an increase in monocyte count (4 studies) was 13% (95% CI 6.0% to 26%) at median specificity (73%; very low-certainty evidence). The summary sensitivity of a decrease in lymphocyte count (13 studies) was 64% (95% CI 28% to 89%) at median specificity (53%; low-certainty evidence). Four studies that evaluated a decrease in lymphocyte percentage showed a lower median specificity and lower corresponding sensitivity. The summary sensitivity of a decrease in platelets (4 studies) was 19% (95% CI 10% to 32%) at median specificity (88%; low-certainty evidence). Liver function tests The summary sensitivity of an increase in alanine aminotransferase (9 studies) was 12% (95% CI 3% to 34%) at median specificity (92%; low-certainty evidence). The summary sensitivity of an increase in aspartate aminotransferase (7 studies) was 29% (95% CI 17% to 45%) at median specificity (81%) (low-certainty evidence). The summary sens

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Authors
Stegeman, I., Ochodo, E. A., Guleid, F., Holtman, G. A., Yang, B., Davenport, C., Deeks, J. J., Dinnes, J., Dittrich, S., Emperador, D., Hooft, L., Spijker, R., Takwoingi, Y., Van den Bruel, A., Wang, J., Langendam, M., Verbakel, J. Y., Leeflang, M. M., & Cochrane COVID-19 Diagnostic Test Accuracy Group
Affiliations
  • University Medical Center Utrecht (NL)
  • Stellenbosch University (ZA)
  • Kenya Medical Research Institute (KE)
  • University Medical Center Groningen (NL)
  • Amsterdam University Medical Centers (NL)
  • University Hospitals Birmingham NHS Foundation Trust (GB)
  • FIND (CH)
  • Utrecht University (NL)
  • Department of Public Health and Primary Care; KU Leuven; Leuven Belgium
  • KU Leuven (BE)
Corresponding author
Leeflang, Mariska MG
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2020-11-19
Volume
2020
Issue
11
Pages
465-467
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd013787
PMC
PMC8078159
OpenAlex
W3101399301
Cited by
76
References
1
Citations by year
2026: 1 · 2025: 8 · 2024: 4 · 2023: 14 · 2022: 23 · 2021: 22 · 2020: 4
FWCI
0.74
Type
journal article
Language
en
Open access
Licence
other-oa
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (publishedVersion, cc-by-nc)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, cc-by-nc)
  • Lirias (KU Leuven) (submittedVersion, other-oa)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
  • Lirias (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
  • Pure Amsterdam UMC (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc)
Funders
  • National Institute for Health and Care Research (PDF-2017-10-059)
  • Medical Research Council (MR/T008768/1)
Topics
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Keywords
COVID-19 pandemic, routine laboratory testing, diagnostic accuracy, triage, clinical decision rules, C-reactive protein, procalcitonin, white blood cell count, sensitivity and specificity, SARS-CoV-2 serology, SARS-CoV-2 RNA detection, SARS-CoV-2 genome
MeSH terms
COVID-19, SARS-CoV-2, COVID-19 Testing, C-Reactive Protein, Creatine Kinase, Creatinine, Diagnostic Tests, Routine, Humans, L-Lactate Dehydrogenase, Leukocyte Count, Liver Function Tests, Platelet Count, Reference Values, ROC Curve, Sensitivity and Specificity, Triage, Biomarkers, Interleukin-6, Bias, Lymphocyte Count, Reverse Transcriptase Polymerase Chain Reaction, Pandemics

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