ClearEpi™ SARS-CoV-2 Antigen Rapid Test
Catalogue No.: CBB-F016028-BLD-C

 

  • Qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal specimen directly from individuals suspected of COVID-19 infection
  • Point of care testing with no additional equipment required
  • Convenient storage conditions : 2 - 30°C
  • High sensitivity, specificity and accuracy
ACCURACY OVER 98%
European CE Marking
(DE/CA70/40838-154686)

CLINICAL DATA PERFORMANCE

The kit showed 98.15% of sensitivity and 98.75% of specificity.

Reagent Test Results RT-PCR Comparator Subtotal
Positive Negative
Positive 53 2 55
Negative 1 158 159
Subtotal 54 160 214

Positive Percent Agreement (PPA) = 53/54 (98.15%) (95%CI: 90.1%~100.0%)

Negative Percent Agreement (NPA) = 158/160 (98.75%) (95%CI: 95.6%~99.8%)

Accuracy = (53+158)/214×100% = 98.60%

Antigen Test - LFA

Catalogue No.: CBB-F016026

  • Qualitative detection of SARS-CoV-2 nucleocapsid (antigen)
  • Sample type: Nasal swab
  • Rapid results: 15 minutes
  • Point of care testing with no additional equipment required
  • Convenient storage conditions : 2 - 30°C
  • High sensitivity and specific
    • - Sensitivity 98.72%
    • - Specificity 97.03%
    • - Accuracy 97.89%

Clinical Performance

An in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens.

Clinical Study Results From Symptom Onset

Reagent Test Results PCR Comparator Subtotal
Positive Negative
Positive 77 3 80
Negative 1 109 110
Subtotal 78 112 190

  • Positive Percent Agreement (PPA) = 77/78(98.72%) (95%CI:93.0%~100%)
  • Negative Percent Agreement (NPA) = 109/112(97.32%) (95%CI:92.4%~99.4%)
  • Accuracy = (77+109)/190x100% = 97.89%
  • Kappa = 2x8390/17450 = 0.96>0.5
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