Guangzhou Labsim Biotech Co.,Ltd

Global (COVID-19) Distribution

Globally, as of 3:06pm CEST, 10 August 2020, there have been 19,718,030 confirmed cases of COVID-19, including 728,013 deaths, reported by WHO.

Situation by WHO Region

COVID-19 SOLUTION

The SARS-COV-2 (also known as CoVID-19 or Novel Coronavirus ) Antigen FIA Rapid Test is a lateral flow immunofluorescent sandwich assay that is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral extraction buffer from individuals who are suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This test is authorized for use at the Point of Care (POC), i.e.

It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with SARS-COV-2. Any reactive specimen with the SARS-COV-2 Antigen FIA must be confirmed with an alternative testing method(s) and clinical findings.

Intended Use

AFS-1000 (single channel) Fluorescent Immunoanalyzer

Principle Dry fluorescence immunoassay

Channel SingleReagent Card Code Bar code& QR code

Printer Embedded, 58mm

Transmission USB2.0, RS232C, Ethernet, LIS, HIS

Screen 7 inches 24 bits Color Touch screenLanguage Chinese and English, othersAnalyzer Size 215mm*302mm*155mmWeight ≤3KgData storage UnlimitedCertification CE,FDA

The SARA-COV-2 Antigen FIA Rapid Test CassetteTest Principle

The Novel Coronavirus Antigen FIA Rapid Test Cassette is a lateral flow immunofluorescence sandwich assay that is used with Fluorescent Immunoanalyzer AFS-1000 to detect nucleocapsid protein from COVID-19. The test cassette consists of: 1) a conjugate pad containing mouse anti-COVID-19 nucleocapsid protein antigen conjugated with fluorescent microsphere（COVID-19 Ab conjugate） and a control antibody conjugated with fluorescent microsphere. 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with mouse anti-COVID-19 nucleocapsid protein antigen, and the C line is pre-coated with a control line antibody. The antibodies to COVID-19 recognize specially the nucleocapsid protein antigens from SARS-COV-2.The patient sample is placed in the Sample Extraction Tube which contain the Extraction Buffer, during which time the virus particles in the sample are disrupted, exposing internal viral nucleocapsid protein. After disruption, the sample is dispensed into the Test Cassette sample well with the pipette. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If COVID-19 viral antigen is present, they will be trapped in a specific location.

Specimen Collection And Handling1. Use the nasopharyngeal swab supplied in the kit.

2. To collect a nasopharyngeal swab sample, carefully insert the swab (provided in the kit) into the nostril or pharynx that presents the most secretion under visual inspection.

3. Using gentle rotation, push the swab until resistance is met at the level of the turbinate.

4. Rotate the swab several times against the nostril or pharynx wall then remove it from the nostril or pharynx.

Sample Preparation Procedure1. Insert the extraction tube into the workstation. Make sure that the tube is standing firm

and reaches the bottom of the workstation .

2. Broken the sealed extraction buffer tube with fingers. Put the swab into the extraction tube, Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube. Leave the swab in the sample tube for 1 minute.

3. Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab. Closed the extraction tube lid. The extracted solution will be used as test sample.

Assay Procedure1. Turn on the power of Fluorescent Immunoanalyzer AFS-1000 and ensure

the instrument in order. Also ensure that the liquid sample is at room temperature before proceeding.

2. Place ID-Card to the Reader Area，press ReadIc button, and the product item information will transfer to Fluorescent Immunoanalyzer AFS-1000.

3. Fill the 100μL Fixed Volume Pipette with the patient sample from the Sample Extraxtion Tube.

4. Drop sample in the sample well of cassette, promptly proceed to the next section, “Using Fluorescent Immunoanalyzer AFS-1000,” to complete the test.

Interpretation of Assayresult

The Novel Coronavirus Antigen FIA Rapid TestStrengths and Highlights

Rapid POCT

l Antigen test result shows in just 20 minutes

l PCR result takes 4-6 hours

Convenience to Use

l Easy to collect sample

High Accurate

l After infection, antigens are earlier to detect than antibodies

l The sample is swab，the same as the PCR test.

The Novel Coronavirus Antigen FIA Rapid TestPackaging

1.Individually Pakaged Test Cassette(25) a. One cassette device b. One desiccant

2.Sample Tubes (25): Sample buffer（0.5ml/bottle）

3.Sterile Nasopharyngeal Swabs (25)

4.ID Card (1)

5.Quick Reference Instructions (1)

Novel Coronavirus Antigen FIAApplication

Transportation Hub

l Airports, railway stations, highway tollbooths, subway stations, ports

Hospital & Clinics

lMedical personnel, suspected cases

Enterprise & Organization

l Government departments, business units, the military, international organizations

For Civil Use

l Towns, schools, communities