Introduction

The KaiBiLi^TM COVID-19 Antigen is an in vitro diagnostic test based on the principle of immuno- chromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swabs. 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. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Donors with a negative result should be treated as presumptive. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
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.

Detection

The qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swabs.

Specimen

Nasal

Limit of Detection (LoD)

2019 Novel Coronavirus: 74.8 TCID₅₀/mL

Accuracy

Positive Percent Agreement: 96.6%
Negative Percent Agreement:100%
Overall Percent Agreement: 98.9%

Time to results

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

Kit storage conditions

2~30°C. 

Contents

Ordering Information