NTENDED USE

The SARS-COV-2 Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 antigens form throat swabs and nasopharyngeal swab specimens.

 It is intended to be used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus.

Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test.

INTRODUCTION

The novel coronaviruses (SARS-CoV-2) belong to the β genus. 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 manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

KIT COMPONENTS

 

Individually packed Test Devices	Each test contains colored conjugates and reactive reagents precoated at the corresponding regions
Extraction solution	For specimens extraction.
Extraction tubes	For specimen preparation
Sterile nasal swabs	For specimen collection
Package insert	For operating instructions

 

PROCEDURE

 

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

• Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
• Gently mix Extraction reagent solution. Add 6 drops(about 200ul) of the Extraction Solution into the Extraction tube. 
• Place the patient swab specimen into the Extraction Tube. Roll the swab at least 10 times while pressing the swab against the bottom and side of the Extraction Tube. Roll the swab head against the inside of the Extraction Tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
• Put on the tube tip, then add 3 drops (about 120ul)  of extracted sample into the sample well. Do not handle or move the Test Device until the test is complete and ready for reading.
• As the test begins to work, color will migrate across the membrane. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

 

Relative Sensitivity: 86.67% (78.07%~95.27%)

Relative Specificity: 100% (99.8%~100%)

Overall Agreement: 95.09% (91.78%~98.41%)

*95% Confidence Interval

 

 

 

 

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.