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Who are At Home Test Manufacturers?

Who makes ‘At home test’ products?

There are 36 testing products approved by the FDA, out of 36 there are 7 products which are approved for At home testing. Reading the jargon filled literature leaflet that is inside each test is confusing at best, so we have tried to make things simple by creating a table below. Hope you find it educational so you can make better decisions about which test you choose.

CompanyBrandtype of testFeatureSpecifications
ACON Labratories, IncFlowFlex Covid-19 Antigen Home TestLateral Flow, Visual Read, Over the Counter (OTC) Home Testing
Test FormatCassette
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample Volume4 to 5 drops of the prepared specimen
Clinical Sensitivity(PPA)*97.1% (83.8%-99.9%) 95% Confidence Intervals
Clinical Specificity(NPA)*99.6% (97.7%-99.9%) 95% Confidence Intervals
LOD1.6*10TCID50/mL
Test Time15 minutes
Shelf Life24 Months
Store Temperature2 – 30 °C (36 - 86°F)
Becton, Dickinson and CompanyBD Veritor At-Home COVID-19 TestLateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial ScreeningTest FormatCassette
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample Volume3 drops
Clinical Sensitivity(PPA)84%(95% CI, 67%-93%)
Clinical Specificity(NPA)100%(95% CI, 98%-100%)
LOD1.4 x 102 TCID50/mL
Test Time15 mins
Shelf Life
Store Temperature2-30°C (35-86°F)
Access Bio, Inc.CareStart COVID-19 Antigen Home TestLateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial ScreeningTest FormatCassette
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample Volume3 drops
Clinical Sensitivity(PPA)87.18% (95% CI: 73.29%-94.40%)
Clinical Specificity(NPA)100.00% (95% CI: 93.24%-100.00%)
LOD8 x 102 TCID50 /ml
Test Time10 mins
Shelf Life12 months
Store Temperature1-30°C (34-86°F)
Abbott Diagnostics Scarborough, Inc.BinaxNOW COVID-19 Antigen Self TestLateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial ScreeningTest FormatCassette
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample Volume6 drops
Clinical Sensitivity(PPA)84.6% (95% CI: 76.8% - 90.6%)
Clinical Specificity(NPA)98.5% (95% CI: 96.6% - 99.5%)
LOD 140.6 TCID50/mL
Test Time15 mins
Shelf Life12 months
Store Temperature2 - 30°C (36 - 86°F)
OraSure Technologies, Inc.InteliSwab COVID-19 Rapid TestLateral Flow, Visual Read, Prescription Home TestingTest FormatProprietary integrated collection swab
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample VolumeN/A
Clinical Sensitivity(PPA)84% (95% CI: 71%, 92%
Clinical Specificity(NPA)98% (95% CI: 93%, 99%)
LOD2.5 x 102 TCID50/mL
Test Time30-40 mins
Shelf Life9 months
Store Temperature 2-30°C (36-86°F)
Quidel CorporationQuickVue At-Home OTC COVID-19 TestLateral Flow, Visual Read, Prescription Home TestingTest FormatDipStick - Test Strips
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample VolumeN/A
Clinical Sensitivity(PPA)83.5%(95% Cl: 74.9% to 89.6%)
Clinical Specificity(NPA)99.2%(95% Cl: 97.2% to 99.8%)
LOD1.91x104 TCID50/mL
Test Time10 mins
Shelf Life24 months
Store Temperature15°C to 35°C (59°F to 86°F)
Ellume LimitedEllume Covid-19 Home TestLateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, ScreeningTest FormatAnalyzer with Bluetooth connectivity
Specimen FormatNasal Swab
Detectsnucleocapsid protein antigen from SARS-CoV-2
Sample Volume5 drops
Clinical Sensitivity(PPA)95% (95% CI 82% - 99%)
Clinical Specificity(NPA)97% (95% CI 93% - 99%)
LOD103.80TCID50/mL
Test Time15 mins
Shelf Life
Store Temperature 2-30°C (36-86°F)

*Sensitivity refers to a test’s ability to designate an individual with disease as positive. Specificity of a test is its ability to designate an individual who does not have a disease as negative.

LOD(LoD). Why does Limit of Detection(LoD) matter?

Edit: Added Ellume’s at home test to the list.