Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people.

  • 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

  1. 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).
  2. 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.
  3. 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.
  1. 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.
  2. 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

9901-NCOV-03G Roche Diagnostics 25 Tests/Kit

Panbio™ COVID-19 Ag Rapid Test Device (Nasal)

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
  • 150 ul
  • 50 ul

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

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.

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