Introduction

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 saliva. 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.

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.

Features & Benefits

The KaiBiLi^TM COVID-19 Antigen Rapid Test is an immunochromatographic assay for the qualitative detection of 2019 Novel Coronavirus antigens. This assay is intended for rapid screening in laboratory. This test should be conducted by trained technician, wearing appropriate personal protective equipment (PPE). The COVID-19 Antigen Rapid Test has two letters on the surface of the test device indicating test line (T) and control line (C). Test line and control line in the result window are not visible before applying any samples. The control line is a reference line which indicates the test is performing properly. The control line must appear every time when the test is performed. If SARS-CoV-2 is present in the sample, the test line would appear. The highly selective antibodies to SARS-CoV-2 are used as capture and detector in the assay. These antibodies can detect SARS-CoV-2 antigens directly, with a high accuracy.

Detection

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

Specimen

Saliva

Limit of Detection (LoD)

2019 Novel Coronavirus: 74.8 TCID₅₀/mL

Accuracy

Positive Percent Agreement: 96.5%

Negative Percent Agreement:97.8%

Overall Percent Agreement: 97.2%

Time to Results

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

Kit Storage Conditions

2~30°C.

Contents

Ordering Information