ANTIGEN TEST - LFA
-
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
- 88.89% sensitivity
- 99.05% specificity
- 96.00% accuracy
Clinical Performance
An in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media.
ANTIGEN TEST - ELISA
-
Quantitative detection of SARS-CoV-2 N protein
-
Sample type: Serum, Plasma
-
Minimal hands-on time of less than 15 mins
-
Key performance index:
- Blank Limit: 1.08pg/mL
- Linear Range: 2.89-180.01pg/mL
- Precision: CV=3.53%-10.07%
-
Clinical performance:
- Positivity Percentage Agreement (PPA) = 95.05%
- Negative Percentage Agreement (NPA) = 100%
Clinical Performance
Positive Coincidence Rate: Positivity Percentage Agreement (PPA) = 96/101 = 95.05%(95 CI: 88.82% ~ 98.37%)
