Rapid Result Covid -19 (Sars Cov-2 ) Tests

Intended use: AIVD COVID-19(SARS-CoV-2) IgG/IgM Rapid Test is a single use, rapid device for qualitative detection of total antibodies against 2019 novel coronavirus (SARS-CoV-2) in human serum, plasma or whole blood specimens. The kit is intended for screening of patients suspected for infection with SARS-CoV-2, and as an aid in the diagnosis of the coronavirus disease 2019 (COVID-19). Descriptionï¼? Novel coronavirus pneumonia (NCP) or SARS-COV-2, that was officially named by the WHO as â??Corona virus disease 2019â?? (COVID-19), is a respiratory infection caused by a new virus that was first identified in late 2019. IgM/IgG Rapid Kit can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness. This kit utilizes the principle of colloidal gold immunochromatography to qualitatively detect the new coronavirus (COVID-19) IgG / IgM antibodies in human serum and plasma. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well, and then add the required amount of a diluent. The IgG / IgM antibodies in the sample will interact with the colloidal gold-labeled COVID-19 recombinant antigen on the conjugate pad. Then the conjugate pad will release re-solubilized conjugate onto the nitrocellulose membrane. The nitrocellulose membrane (NC membrane) diffuses it forward. As the sample moves along the device binding reagents situated on the nitrocellulose membrane bind to the target at the test line. If the sample contains a COVID-19 IgG antibodies, they will bind to the colloidal gold-labeled novel coronavirus recombinant antigen, diffuse forward, and then react with the anti-human IgG antibodies immobilized on the NC membrane detection line (T2 line). Similarly, if the specimen contains IgM antibodies to COVID-19, the antibodies will react with antigen-coated particles, the conjugate migrate laterally forward, and cause a colored line (T1 line). The darker the color of colloidal gold on the test line, the higher the concentration antibodies to COVID-19 in the sample. Accuracy:ï¼?> 90% Specificity: 97% Basic Protocolï¼? 1. Remove the test specimen, required reagents from storage conditions, and equilibrate to room temperature. 2. Unpack the aluminum foil bag, place the test horizontally on the table and number it. 3. Add 10ul serum, plasma or whole blood sample to the sample well with a pipette or a dropper. Slowly add 2 drops of sample dilution (about 60uL) to the sample well. 4. Read the results within 10-15 minutes after adding the sample, and the results will be invalid after 30 minutes.

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.

Anti-SARS-CoV-2 Rapid Test, COVID-19 1. Easier: No special equipment needed, Intuitive visual interpretation. 2. Rapid: Quick sampling by fingertip blood, Results in 10-15min. 3. Accurate: Results with IgG and IgM respectively. 4. Application: as screening tool for potential suspect patients in large numbers. Testing kit is FDA Emergency Use Authorization (EUA) Approved Testing kit is CE MARKED-IVD * Instruction for Use * Interpretation Guide * SARS-CoV-2 immunoassays * Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit * Anti-SARS Rapid Test Brochure * COVID-19 Catalog * EUA Approval Letter * Fact Sheet for Healthcare Providers * FDA Letter * Fact Sheet for Recipients * FAQ * CE IVD Notification Certificate Antibody Performance Measure Estimate of Performance 95% Confidence Interval IgM Sensitivity (PPA) 95.7% (289/302) (92.8%; 97.5%) IgM Specificity (NPA) 99.7% (311/312) (98.2%; 99.9%) IgG Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%) IgG Specificity (NPA) 99.4% (310/312) (97.7%; 99.8%) Combined Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%) Combined Specificity (NPA) 99% (309/312) (97.2%; 99.7%) Combined PPV at prevalence = 5% 84.4% (64.6%; 94.6%) Combined NPV at prevalence = 5% 99.9% (99.8%; 100%) Testing kit is FDA Emergency Use Authorization (EUA) Approved Testing kit is CE MARKED-IVD * Instruction for Use * Interpretation Guide * SARS-CoV-2 immunoassays * Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit * Anti-SARS Rapid Test Brochure * COVID-19 Catalog * EUA Approval Letter * Fact Sheet for Healthcare Providers * FDA Letter * Fact Sheet for Recipients * FAQ * CE IVD Notification Certificate

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COVID-19 Antigen Rapid Test (Self-Test at Home) Immediate stock : 78,000 test kits OTG Price : USD13.80 per box (2 test kits per box)

Rapid antigen test kit for detection of COVID-19 . Easy,safe and accurate

European CE Certified 15 Minutes Detection Time Format 25T/Kit Colloidal Gold Method Detection Substance: Antibody Type of Sample : Serum/Plasma/Whole Blood No instruments needed

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