Covid-19 (Sars-Cov-2) Antigen Test

Test Kit for self test 1 test/ 5 tests/ 20 test per kit

Test Kit for self test (nasal swab) 1 test/ 5 tests/ 20 test per kit

AIVD Biotechs COVID-19 Ag test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein (NP) antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19. Description This kit utilizes the principle of latex bead immunochromatography to qualitatively detect the new coronavirus (COVID-19) Np antigen in human nasal swabs. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. The test contains latex bead conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible band appears on the test lines (T) as antibody-antigen-antibody latex bead complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly. This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well. If sample contains the antigen, it will interact with the latex bead-labeled COVID-19 anti-SARS-COV-2 NP antibodies on the conjugate pad. Required components 1. A foil pouch with a desiccant and a single-use test card, 1 piece 3. Sterile swab, 1 piece 3. Extraction buffer tube (1 ml), 1 tube. 4. Instructions for use, 1 piece. Specimen requirements: 1. Nasopharyngeal swab specimen. 2.Specimen should be tested as soon as possible upon collection. If the sample has to be stored, store the swab sample at room temperature for up to 1 hour or 2~8â?? for up to 4 hours prior to testing. Specimen preparation 1. Insert the extraction buffer tube into the tube rack, make sure that the sample tube is firmly upright and touches the bottom of the rack. 2. Insert the swab into an extraction buffer tube. 3. Gently stir the swab in the tube, and then left swab inside the tube for 1 minute or Mix on the vortex mixer for about 30 seconds, 4. The sample should be tested immediately after collection. If it cannot be tested in time, it should be stored in the virus transport matrix. The specimens can be stored at 2-8C for 4 hours Basic Protocol Step 1: If the sample is refrigerated, remove the sample to be tested and the required reagents from the storage conditions, equilibrate to room temperature (15~30C) Step 2: When preparing to test, open the aluminum foil bag, take out the test card, and lay it flat on a table. Step 3: Mark the sample number on the test card, Step 4: Using pipette add 50ul of the sample into a sample well on the device, Step 5: Read the result within 15 minutes, Please read the result after 15 minutes. After observing and recording the result, please discard the test card to avoid affecting the result judgment. Do not read test results after 30 minutes. It may give false results.

INTENDED USE For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection. FEATURES Coated with carefully selected specific Nucleocapsid and Spike protein antigen. Detection for IgM and IgG antibodies simultaneously. Simple operation, easy result interpreted. Rapid test within 15 minutes. RESULTS INTERPRETATION Positive: 1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies. 2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody. 3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody. Negative: 1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative. Invalid: 1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested. 2. The test result is invalid after 15 min. CLINICAL PERFORMANCE - Positive Percent Agreement (PPA) = 91.07% (153/168) (95% CI: 85.70%-94.92%). - Negative Percent Agreement (NPA) = 95.37% (103/108) (95% CI: 89.53%-98.48%). - Overall Rates of Agreement (ORA) = 92.75% [(153+103)/ (168+108)] (95% CI: 89.03%-95.52%). [Product Name]: SARS-CoV-2 IgM/IgG Duo Test [Product Code]: Cat# FP-319 [Sample Type]: Whole blood /Plasma/Serum [Sample Volume]: 20L /10L/10L [Detection Method]: Colloidal Gold [Reaction Time]: 10-15min [Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL. [Storage Condition]: 2oC ~ 30oC [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/499/2021.

INTENDED USE For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection. FEATURES Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2. Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva. Easy to use, easy results interpretation by naked eyes. Test result available within 15minutes. TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit. RESULTS INTERPRETATION Positive: A red line appears on the test line (T) and the control line (C). NOTE: A positive result does not rule out co-infections with other pathogens. Negative: Only the control line (C) appears, and no red line appears on the test line (T). NOTE: A negative result does not exclude infection. Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again. CLINICAL PERFORMANCE SARS-CoV-2 Antigen Test Kit Comparator Method (NTA) Positive Negative Total Positive 97 0 97 Negative 3 100 103 Total 100 100 200 - Positive Agreement (95% CI): 97/100 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100 100.0% (95.5% - 100%) - LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen. - Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable. - No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track. - Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%). [Product Name]: SARS-CoV-2 Antigen Test [Product Code]: Cat# FP-318 [Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva [Detection Method]: Colloidal Gold [Reaction Time]: Within 15min [Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1. [Storage Conditions]: 2*C ~ 30*C [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/99/2021.