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Meta-Analysis
. 2020 Aug 26;8(8):CD013705.
doi: 10.1002/14651858.CD013705.

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection

Jacqueline Dinnes  1   2 , Jonathan J Deeks  1   2 , Ada Adriano  1 , Sarah Berhane  2 , Clare Davenport  1   2 , Sabine Dittrich  3 , Devy Emperador  3 , Yemisi Takwoingi  1   2 , Jane Cunningham  4 , Sophie Beese  1 , Janine Dretzke  1 , Lavinia Ferrante di Ruffano  1 , Isobel M Harris  1 , Malcolm J Price  1 , Sian Taylor-Phillips  5 , Lotty Hooft  6 , Mariska Mg Leeflang  7   8 , René Spijker  6   9 , Ann Van den Bruel  10 ; Cochrane COVID-19 Diagnostic Test Accuracy Group  2
Affiliations
Meta-Analysis

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection

Jacqueline Dinnes et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the resulting COVID-19 pandemic present important diagnostic challenges. Several diagnostic strategies are available to identify or rule out current infection, identify people in need of care escalation, or to test for past infection and immune response. Point-of-care antigen and molecular tests to detect current SARS-CoV-2 infection have the potential to allow earlier detection and isolation of confirmed cases compared to laboratory-based diagnostic methods, with the aim of reducing household and community transmission.

Objectives: To assess the diagnostic accuracy of point-of-care antigen and molecular-based tests to determine if a person presenting in the community or in primary or secondary care has current SARS-CoV-2 infection.

Search methods: On 25 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 studies of people with suspected current SARS-CoV-2 infection, known to have, or not to have SARS-CoV-2 infection, or where tests were used to screen for infection. We included test accuracy studies of any design that evaluated antigen or molecular tests suitable for a point-of-care setting (minimal equipment, sample preparation, and biosafety requirements, with results available within two hours of sample collection). We included all reference standards to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction (RT-PCR) tests and established clinical diagnostic criteria).

Data collection and analysis: Two review authors independently screened studies and resolved any disagreements by discussion with a third review author. One review author independently extracted study characteristics, which were checked by a second review author. Two review authors independently extracted 2x2 contingency table data and assessed risk of bias and applicability of the studies using the QUADAS-2 tool. We present sensitivity and specificity, with 95% confidence intervals (CIs), for each test using paired forest plots. We pooled data using the bivariate hierarchical model separately for antigen and molecular-based tests, with simplifications when few studies were available. We tabulated available data by test manufacturer.

Main results: We included 22 publications reporting on a total of 18 study cohorts with 3198 unique samples, of which 1775 had confirmed SARS-CoV-2 infection. Ten studies took place in North America, two in South America, four in Europe, one in China and one was conducted internationally. We identified data for eight commercial tests (four antigen and four molecular) and one in-house antigen test. Five of the studies included were only available as preprints. We did not find any studies at low risk of bias for all quality domains and had concerns about applicability of results across all studies. We judged patient selection to be at high risk of bias in 50% of the studies because of deliberate over-sampling of samples with confirmed COVID-19 infection and unclear in seven out of 18 studies because of poor reporting. Sixteen (89%) studies used only a single, negative RT-PCR to confirm the absence of COVID-19 infection, risking missing infection. There was a lack of information on blinding of index test (n = 11), and around participant exclusions from analyses (n = 10). We did not observe differences in methodological quality between antigen and molecular test evaluations. Antigen tests Sensitivity varied considerably across studies (from 0% to 94%): the average sensitivity was 56.2% (95% CI 29.5 to 79.8%) and average specificity was 99.5% (95% CI 98.1% to 99.9%; based on 8 evaluations in 5 studies on 943 samples). Data for individual antigen tests were limited with no more than two studies for any test. Rapid molecular assays Sensitivity showed less variation compared to antigen tests (from 68% to 100%), average sensitivity was 95.2% (95% CI 86.7% to 98.3%) and specificity 98.9% (95% CI 97.3% to 99.5%) based on 13 evaluations in 11 studies of on 2255 samples. Predicted values based on a hypothetical cohort of 1000 people with suspected COVID-19 infection (with a prevalence of 10%) result in 105 positive test results including 10 false positives (positive predictive value 90%), and 895 negative results including 5 false negatives (negative predictive value 99%). Individual tests We calculated pooled results of individual tests for ID NOW (Abbott Laboratories) (5 evaluations) and Xpert Xpress (Cepheid Inc) (6 evaluations). Summary sensitivity for the Xpert Xpress assay (99.4%, 95% CI 98.0% to 99.8%) was 22.6 (95% CI 18.8 to 26.3) percentage points higher than that of ID NOW (76.8%, (95% CI 72.9% to 80.3%), whilst the specificity of Xpert Xpress (96.8%, 95% CI 90.6% to 99.0%) was marginally lower than ID NOW (99.6%, 95% CI 98.4% to 99.9%; a difference of -2.8% (95% CI -6.4 to 0.8)) AUTHORS' CONCLUSIONS: This review identifies early-stage evaluations of point-of-care tests for detecting SARS-CoV-2 infection, largely based on remnant laboratory samples. The findings currently have limited applicability, as we are uncertain whether tests will perform in the same way in clinical practice, and according to symptoms of COVID-19, duration of symptoms, or in asymptomatic people. Rapid tests have the potential to be used to inform triage of RT-PCR use, allowing earlier detection of those testing positive, but the evidence currently is not strong enough to determine how useful they are in clinical practice. Prospective and comparative evaluations of rapid tests for COVID-19 infection in clinically relevant settings are urgently needed. Studies should recruit consecutive series of eligible participants, including both those presenting for testing due to symptoms and asymptomatic people who may have come into contact with confirmed cases. Studies should clearly describe symptomatic status and document time from symptom onset or time since exposure. Point-of-care tests must be conducted on samples according to manufacturer instructions for use and be conducted at the point of care. Any future research study report should conform to the Standards for Reporting of Diagnostic Accuracy (STARD) guideline.

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Conflict of interest statement

Jonathan J Deeks: none known

Jacqueline Dinnes: none known

Yemisi Takwoingi: none known

Clare Davenport: none known

Mariska MG Leeflang: none known

René Spijker: the Dutch Cochrane Centre (DCC) has received grants for performing commissioned systematic reviews. In no situation, the commissioner had any influence on the results of the work.

Lotty Hooft: none known

Ann Van den Bruel: none known

Devy Emperador: is employed by FIND with funding from DFID and KFW. FIND is a global non‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high quality diagnostic tools for low resource settings and this is achieved by supporting both R&D and access activities for a wide range of diseases, including COVID‐19. .FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Sabine Dittrich: is employed by FIND with funding from DFID and Australian Aid. FIND is a global non‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high quality diagnostic tools for low resource settings and this is achieved by supporting both R&D and access activities for a wide range of diseases, including COVID‐19. .FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Ada Adriano: none known

Sophie Beese: none known

Janine Dretzke: none known

Lavinia Ferrante di Ruffano: none known

Isobel Harris: none known

Malcolm Price: none known

Sian Taylor‐Phillips: none known

Sarah Berhane: is funded by NIHR Birmingham Biomedical Research Centre.

Jane Cunningham: none known

Figures

1
1
Study flow diagram
2
2
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies. Numbers in the bars indicate the number of studies
3
3
Forest plot of studies evaluating antigen tests. Studies grouped by test
(FIA: fluorescence immunoassays; CGIA: colloidal gold‐based immunoassays; NP: nasopharyngeal; OP: oropharyngeal)
4
4
Forest plot of studies evaluating rapid molecular tests. Studies grouped by test and sample type
(NP: nasopharyngeal; OP: oropharyngeal; RUO: research use only)
5
5
Forest plot of studies evaluating antigen tests according to viral load: high (≤ 25 Ct) versus low viral load (≤ 30 Ct in Diao 2020). Studies grouped by test
6
6
Forest plot of studies evaluating rapid molecular tests according to viral load: high (≤ 30 Ct) versus low viral load. Studies grouped by test
7
7
Forest plot of studies of molecular tests before and after discrepant analysis. Studies grouped by test
(DRW: Diagnostics for the Real World; RUO: research use only)
8
8
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study
1
1. Test
Antigen tests ‐ All
2
2. Test
Antigen tests ‐ high viral load
3
3. Test
Antigen tests ‐ low viral load
4
4. Test
Molecular tests ‐ all
5
5. Test
Molecular tests ‐ all (before discrepant analysis)
6
6. Test
Molecular tests ‐ all (after discrepant analysis)
7
7. Test
Molecular tests ‐ high viral load
8
8. Test
Molecular tests ‐ low viral load
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References

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