NUEVO COVID-19 Ag

Detection of SARS-CoV-2 AntiGen

NUEVO COVID-19 Ag Test Kit is a chromatographic immunoassay kit for rapid, qualitative and convenient detection of SARS-CoV-2 antigen in nasopharyngeal swab sputum specimen from human. Test kit contains a membrane strip, which is immobilized with the anti-SARS-CoV-2 monoclonal anti-body on the test line (T) and Goat-anti mouse IgG on the control line (C) respectively.

When the sample and the extraction solution are applied to the sample well, the sample is moved to the gold conjugated pad and reacts with anti-SARS-CoV-2 monoclonal anti-body coupled gold conjugate followed by reaction with anti-SARS- CoV-2 monoclonal antibody immobilized in the test line.

When the sample contains SARS-CoV-2 antigens, a visible line appears in the test region on the membrane, The solution continues to migrate to encounter a control reagent that binds a control conjugage, thereby producing another band in the contol region.

Product: NUEVO COVID-19 Ag

Category: Diagnosis Kit

Date: March 2021

SAMPLE

Sample Type : Nasopharyngeal swab specimen from human
Sample Storage : All specimens should be tested immediately

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity : 90.9%
Clinical Specificity : 96.9%

ANALYTICAL SENSITIVITY

Limit of Detection (LoD) LoD of Heat- inactivated SARS-CoV-2 is 7.50×103 TCID50/ml.

ANALYTICAL SPECIFICITY

Cross-Reactivity : No cross- reactivity was observed with influenza A virus, influenza B virus.
No interference was observed with Albumin human, Salicylic Acid, Hemoglobin human, Ethanol, Acetaminophen, Caffeine, Aspirin and Ibuprofen