Introduction

COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms including manifestations include fever, fatigue and dry cough, nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

The KaiBiLi^TM COVID-19 Antigen Rapid Test Device is an in vitro diagnostic test based on the principle of immunochromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of 2019 Novel Coronavirus. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infection.

This assay is intended for rapid screening in laboratory. This test should be conducted by trained technician, wearing appropriate personal protective equipment (PPE). 

Detection

The qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab.

Specimen

Nasal or Nasopharyngeal 

Limit of Detection (LoD)

SARS-CoV-2: 140 TCID₅₀/mL

Accuracy（Nasal swab）

Positive Percent Agreement: 96.6%

Negative Percent Agreement:100%

Overall Percent Agreement: 98.9%

Accuracy (Nasopharyngeal swab）

Positive Percent Agreement: 97.0%

Negative Percent Agreement:98.3%

Overall Percent Agreement: 97.7%

Time to Results

Read results at 15minutes and no more than 30 minutes. 

Kit storage conditions

2~30°C. 

Contents

Ordering Information