- Self-testing for COVID-19 infection with lateral flow assay SARS-CoV-2 rapid antigen detection tests (RDT), provides rapid results and could enable frequent and extensive testing in the community, thereby improving the control of SARS-CoV-2. The objective of this study was to evaluate the performance of nasal mid-turbinate self-testing using RDT for persons suspected with COVID-19 in the community.
- Participants visiting a municipal SARS-CoV-2 testing centre, received self-testing kits containing either the BD Veritor System (BD-RDT) or Roche SARS-CoV-2 antigen detection test (Roche-RDT). Oro-nasopharyngeal swabs were collected from the participants for qRT-PCR testing. As a proxy for contagiousness, viral culture was performed on a selection of qRT-PCR positive samples to determine the Ct-value at which the chance of a positive culture was dropping below 0.5 (Ct-value cut-off). Sensitivity and specificity of self-testing were compared to qRT-PCR with a Ct-value below the Ct value cut-off. Determinants independently associated with a false-negative self-test result were determined.
- A total of 3,201 participants were included (BD-RDT n=1595; Roche-RDT n=1606). Sensitivity and specificity of self-testing compared to the qRT-PCR results with a Ct-value below the Ct-value cut-off was 78.4% (95% CI:73.2-83.5) and 99.4% (95%CI: 99.1-99.7) respectively. A higher age was independently associated with a false-negative Antigen Nasal test kit IVD self-testing result with an odds ratio of 1.024 (95%CI:1.003-1.044).
- Self-testing using currently available RDT’s has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness.
A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study
- The LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point-of-care settings (NCT04557046).
- Two paired anterior nasal swabs or two paired nasopharyngeal swabs were collected from each participant. Swabs were tested by the LumiraDx SARS-CoV-2 antigentest and compared with real-time polymerase chain reaction (rt-PCR; Roche cobas 6800 platform). Sensitivity, specificity and likelihood ratios were calculated. Results were stratified on the basis of gender, age, duration of symptoms, and rt-PCR cycle threshold.
- Out of the 512 participants, aged 0-90 years, of this prospective validation study, 414 (81%) were symptomatic for COVID-19 and 123 (24%) swabs were positive for SARS-CoV-2 based on rt-PCR testing. Compared with rt-PCR, the 12-min nasal swab test had 97.6% sensitivity and 96.6% specificity, and nasopharyngeal swab had 97.5% sensitivity and 97.7% specificity, within 12 days of symptom onset, representing the period of infectivity. All (100%) samples detected within 33 rt-PCR cycles were also identified using the antigen test. Results were consistent across age and gender. The user error rate of the test system when used by minimally trained operators was 0.7% (95% confidence interval [CI] 0.1-3.7%).
The rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling may offer significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings. COVID-19; LumiraDx antigen test; Rt-PCR; SARS-Co.
Detection of SARS-CoV-2 infection in the general population by three prevailing rapid antigen tests: cross-sectional diagnostic accuracy study.
Rapid antigen diagnostic tests (Ag-RDTs) are the most widely used point-of-care tests for detecting SARS-CoV-2 infection. Since the accuracy may have altered by changes in SARS-CoV-2 epidemiology, indications for testing, sampling and testing procedures, and roll-out of COVID-19 vaccination, we evaluated the performance of three prevailing SARS-CoV-2 Ag-RDTs.
- In this cross-sectional study, we consecutively enrolled individuals aged >16 years presenting for SARS-CoV-2 testing at three Dutch public health service COVID-19 test sites. In the first phase, participants underwent either BD-Veritor System (Becton Dickinson), PanBio (Abbott), or SD-Biosensor (Roche Diagnostics) testing with routine sampling procedures. In a subsequent phase, participants underwent SD-Biosensor testing with a less invasive sampling method (combined oropharyngeal-nasal [OP-N] swab). Diagnostic accuracies were assessed against molecular testing.
- Six thousand nine hundred fifty-five of 7005 participants (99%) with results from both an Ag-RDT and a molecular reference test were analysed. SARS-CoV-2 prevalence and overall sensitivities were 13% (188/1441) and 69% (129/188, 95% CI 62-75) for BD-Veritor, 8% (173/2056) and 69% (119/173, 61-76) for PanBio, and 12% (215/1769) and 74% (160/215, 68-80) for SD-Biosensor with routine sampling and 10% (164/1689) and 75% (123/164, 68-81) for SD-Biosensor with OP-N sampling. In those symptomatic or asymptomatic at sampling, sensitivities were 72-83% and 54-56%, respectively.
- Above a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities were 86% (125/146, 79-91) for BD-Veritor, 89% (108/121, 82-94) for PanBio, and 88% (160/182, 82-92) for SD-Biosensor with routine sampling and 84% (118/141, 77-89) with OP-N sampling. Specificities were >99% for all tests in most analyses. Sixty-one per cent of false-negative Ag-RDT participants returned for testing within 14 days (median: 3 days, interquartile range 3) of whom 90% tested positive.
- Overall sensitivities of three SARS-CoV-2 Ag-RDTs were 69-75%, increasing to ≥86% above a viral load cut-off. The decreased sensitivity among asymptomatic participants and high positivity rate during follow-up in false-negative Ag-RDT participants emphasise the need for education of the public about the importance of re-testing after an initial negative Ag-RDT should symptoms develop. For SD-Biosensor, the diagnostic accuracy with OP-N and deep nasopharyngeal sampling was similar; adopting the more convenient sampling method might reduce the threshold for professional testing.
Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children
The LumiraDx SARS-CoV-2 Ag Test has previously been shown to accurately detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals symptomatic for coronavirus disease 2019 (COVID-19). This evaluation investigated the LumiraDx SARS-CoV-2 Ag Test as an aid in the diagnosis of SARS-CoV-2 infection in asymptomatic adults and children.
- Asymptomatic individuals at high risk of COVID-19 infection were recruited in 5 point-of-care (POC) settings. Two paired anterior nasal swabs were collected from each participant, tested by using the LumiraDx SARS-CoV-2 Ag Test at the POC, and compared with results from reverse transcription-polymerase chain reaction (RT-PCR) assays (cobas 6800 [Roche Diagnostics] or TaqPath [Thermo Fisher Scientific]). We calculated positive percent agreement (PPA) and negative percent agreement (NPA), then stratified results on the basis of RT-PCR reference platform and cycle threshold.
- Of the 222 included study participants confirmed to be symptom-free for at least 2 weeks before testing, the PPA was 82.1% (95% confidence interval [CI], 64.4%-92.1%). The LumiraDx SARS-CoV-2 Ag Test correctly identified 95.8% (95% CI, 79.8%-99.3%) of the samples confirmed positive in fewer than 33 RT-PCR cycles and 100% (95% CI, 85.1%-100%) in fewer than 30 RT-PCR cycles while maintaining 100% NPA.
SARS-CoV-2 Rapid Antigen Test Nasal |
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| 9901-NCOV-03G | Roche Diagnostics | 25 Tests/Kit |
Panbio™ COVID-19 Ag Rapid Test Device (Nasal) |
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| 41FK11 | Abbott | 25 Tests/Kit |
CEA (Cancer antigen) ELISA test |
||
| 9 | Biobase | 96T/Box |
CA50 (Cancer antigen) ELISA test |
||
| 10 | Biobase | 96T/Box |
CA125 (Cancer antigen) ELISA test |
||
| 11 | Biobase | 96T/Box |
CA153 (Cancer antigen) ELISA test |
||
| 12 | Biobase | 96T/Box |
CA199 (Cancer antigen) ELISA test |
||
| 13 | Biobase | 96T/Box |
NOVATest Antigen Rapid Test Kit (For Single Use) (NOVA Test) |
||
| nCov-500-01 | Atlas Link Technology | 1T |
NOVATest Antigen Rapid Kit (NOVA Test) |
||
| nCov-500 | Atlas Link Technology | 20 Tests |
PSA (Prostate-specific antigen) ELISA test |
||
| 8 | Biobase | 96T/Box |
SARS-CoV-2 Antigen Rapid Test Kit |
||
| CoV2Ag-1 | UnScience | 1T |
SARS-CoV-2 Antigen Rapid Test Kit |
||
| CoV2Ag-25 | UnScience | 25T/kit |
HEV-Ag hepatitis E antigen ELISA test |
||
| 94 | Biobase | 96T/Box |
HBeAg hepatitis B E antigen ELISA test |
||
| 79 | Biobase | 96T/Box |
HBsAg hepatitis B surface antigen ELISA test |
||
| 77 | Biobase | 96T/Box |
Bovine NASAL SEPTUM 500g* |
||
| 57128-2 | Pel-Freez | 500g |
Human Streptococcus Pneumoniae (SP) Antigen Rapid Test Kit |
||
| abx092096-20tests | Abbexa | 20 tests |
Recombinant human RHD antigen |
||
| P1958 | FN Test | 100ug |
Nasal Embryonic Lhrh Factor Antibody |
||
| 20-abx114026 | Abbexa |
|
Avian Influenza Virus Antigen Rapid Test Kit (Colloidal gold) |
||
| abx092015-40tests | Abbexa | 40 tests |
Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) |
||
| IOV87952 | INVBIO | 20T/kit |
Head and neck (nasal cavity |
||
| HN601d | TissueArray | each |
Rat Cd44(CD44 antigen) ELISA Kit |
||
| ER0342 | FN Test | 96T |
Rat CA125(Carbohydrate Antigen 125) ELISA Kit |
||
| ER0788 | FN Test | 96T |
Newcastle Disease Virus Antigen Rapid Test Kit (Colloidal gold) |
||
| abx092016-40tests | Abbexa | 40 tests |
Mouse CA125(Carbohydrate Antigen 125) ELISA Kit |
||
| EM0887 | FN Test | 96T |
Mouse CD44( CD44 antigen) ELISA Kit |
||
| EM0433 | FN Test | 96T |
Rat Alcam(CD166 antigen) ELISA Kit |
||
| ER0216 | FN Test | 96T |
Human CD48(CD48 antigen) ELISA Kit |
||
| EH4332 | FN Test | 96T |
Human CD81(CD81 antigen) ELISA Kit |
||
| EH7221 | FN Test | 96T |
Human CD44(CD44 antigen) ELISA Kit |
||
| EH0654 | FN Test | 96T |
Recombinant human Lymphocyte antigen 6K |
||
| P2272 | FN Test | 100ug |
Mouse Alcam(CD166 antigen) ELISA Kit |
||
| EM0324 | FN Test | 96T |
Human CD109(CD109 antigen) ELISA Kit |
||
| EH1701 | FN Test | 96T |
Human CD177(CD177 antigen) ELISA Kit |
||
| EH1752 | FN Test | 96T |
Human ALCAM(CD166 antigen) ELISA Kit |
||
| EH0001 | FN Test | 96T |
Human CD276(CD276 antigen) ELISA Kit |
||
| EH0634 | FN Test | 96T |
Human Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal gold) |
||
| abx092049-20tests | Abbexa | 20 tests |
Human CA-125(Carbohydrate Antigen 125) ELISA Kit |
||
| EH0361 | FN Test | 96T |
Avian Influenza H5 Virus Antigen Rapid Test Kit (Colloidal gold) |
||
| abx092014-40tests | Abbexa | 40 tests |
Avian Influenza H7 Virus Antigen Rapid Test Kit (Colloidal gold) |
||
| abx092017-40tests | Abbexa | 40 tests |
Human MKI67(Antigen KI-67) ELISA Kit |
||
| EH0684 | FN Test | 96T |
Mouse CD5l( CD5 antigen-like) ELISA Kit |
||
| EM0762 | FN Test | 96T |
Human CD5L(CD5 antigen-like) ELISA Kit |
||
| EH2229 | FN Test | 96T |
Human CD52(CAMPATH-1 antigen) ELISA Kit |
||
| EH1286 | FN Test | 96T |
Human CEA(Carcinoembryonic Antigen) ELISA Kit |
||
| EH0090 | FN Test | 96T |
Recombinant human B-lymphocyte antigen CD19 |
||
| P1837 | FN Test | 100ug |
Recombinant human B-lymphocyte antigen CD20 |
||
| P2398 | FN Test | 100ug |
Human LY75(Lymphocyte antigen 75) ELISA Kit |
||
| EH0299 | FN Test | 96T |
Rat PSA(Prostate Specific Antigen) ELISA Kit |
||
| ER1293 | FN Test | 96T |
Mouse Ly6c1( Lymphocyte antigen 6C1) ELISA Kit |
||
| EM0555 | FN Test | 96T |
Rat TPA(Tissue Polypeptide Antigen) ELISA Kit |
||
| ER1398 | FN Test | 96T |
Human CA50(Carbohydrate Antigen 50) ELISA Kit |
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| EH1396 | FN Test | 96T |
Recombinant human Antigen peptide transporter 1 |
||
| P1680 | FN Test | 100ug |
Mouse PSA(Prostate Specific Antigen) ELISA Kit |
||
| EM1314 | FN Test | 96T |
Mouse TPA(Tissue Polypeptide Antigen) ELISA Kit |
||
| EM1633 | FN Test | 96T |
Human TPA(Tissue Polypeptide Antigen) ELISA Kit |
||
| EH3901 | FN Test | 96T |
Recombinant human Melanoma-associated antigen 3 |
||
| P1547 | FN Test | 100ug |
Recombinant human Melanoma-associated antigen 2 |
||
| P1622 | FN Test | 100ug |
Human HLA-A(Leukocyte Antigen A) ELISA Kit |
||
| EH3227 | FN Test | 96T |
Rat Tp53(Cellular tumor antigen p53) ELISA Kit |
||
| ER0394 | FN Test | 96T |
Human GPA33(Cell surface A33 antigen) ELISA Kit |
||
| EH1535 | FN Test | 96T |
Human PSCA(Prostate stem cell antigen) ELISA Kit |
||
| EH2380 | FN Test | 96T |
Human SSA(Sjogren syndrome antigen A) ELISA Kit |
||
| EH4256 | FN Test | 96T |
Human CYFRA21-1(Cytokeratin Fragment Antigen 21-1) ELISA Kit |
||
| EH0364 | FN Test | 96T |
Human LCA/CD45(Leukocyte Common Antigen) ELISA Kit |
||
| EH3290 | FN Test | 96T |
Human SPAG5(sperm associated antigen 5) ELISA Kit |
||
| EH4134 | FN Test | 96T |
Human MS4A1(B-lymphocyte antigen CD20) ELISA Kit |
||
| EH14877 | FN Test | 96T |
Human CD69(Early activation antigen CD69) ELISA Kit |
||
| EH1314 | FN Test | 96T |
Human CD2(T-cell surface antigen CD2) ELISA Kit |
||
| EH0466 | FN Test | 96T |
This rapid, high-sensitivity test can be used to screen asymptomatic patients for acute SARS-CoV-2 infection in clinic- and community-based settings.Asymptomatic; COVID-19; LumiraDx antigen test; RT-PCR; SARS-CoV-2; Sensitivity.