Information on Antigen Testing


 
BinaxNow
Lumira Dx
Quidel Sofia SARS
BD Veritor plus
Technique
Lateral flow immunoassay
Fluorescent Immunoassay (FIA)
Fluorescent Immunoassay (FIA)
Immunochromatographic assay
Detects
Qualitative detection of nucleocapsid protein
Qualitative detection of nucleocapsid protein
Qualitative detection of nucleocapsid protein
Qualitative detection of nucleocapsid protein
Analysis time
15 minutes
12 minutes
15 minutes
15 minutes
Regulatory approval
EUA, CLIA-waived
EUA, CLIA-waived
EUA, CLIA-waived,
EUA, CLIA-waived
Testing locations
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
 
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
 
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Disposables
Test cards
Test strips
Test cassettes
Test cassettes
Instruments
None, visual read
LumiraDx Instrument required
Sofia or Sofia 2 required
BD Veritor Plus Analyzer required
Intended use
Qualitative detection of the nucleocapsid protein antigen to SARSCoV-2 directly from nasal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
BinaxNow tests does not differentiate between SARS-CoV and SARS-CoV-2.
Qualitative detection of the nucleocapsid protein antigen to SARSCoV-2 directly from nasal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2.
Qualitative detection of the nucleocapsid protein antigen from SARS-COV and  SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID19 by their healthcare provider within the first five days of the onset of symptoms.
Intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Collection method
Dry nasal swab (available as an optional accessory)
Dry nasal swab (not provided)
Dry nasal and NP (not supplied) swabs
Dry nasal swab
LOD (Inactivated BEI inactivated virus suspension)
22.5 TCID50/ml
32 TCID50/ml
113 TCID50/ml
140 TCID50/ml
LOD (estimated genomic c/ml)3
608,108 c/ml
864,864 c/ml
3,054,054 c/ml
3,783,780 c/ml
Sensitivity vs NP, OP and or Nasal w EUA PCR (PI)
97.1 (nasal)4
97.6 (nasal)
96.7% 1 (NP and nasal)
84% (NP and OP)
Specificity vs NP, OP and or Nasal w EUA PCR (PI) 
98.5
96.6
100%2
100%
Cost
$5?
?
?
$31
Availability
?
UK company with office in US. 
HHS pouring resources into both company to ramp up production.
HHS pouring resources into company to ramp up production.
Mid-September?
MUSC experience
Yes5
None
None
We currently use Veritor influenza test throughout the system

 

1. Abbott Alinity m EUA IFU LOD 100c/ml = 0.0037 TCID50/ml, therefore 1 TCID50/ml = 27,027c/ml.
2. Probably a gross overestimate of sensitivity considering their influenza assay based on the same platform had sensitivity of 80% in a recent meta-analysis of rapid influenza tests.u
3. Recent user reports of significant issues with false positive results under investigation.
4. 
PPA and NPA were 75% and 92% in a group of 28 patients with symptom onset >7days. 
5. Historically among the poorest performers for detection of INF A/B viruses (Merckz, et al 2017 Ann Intern Med)
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