Sars-Cov-19 Rapid Test

Product Name: Coronavirus (COVID-19) Antigen Rapid Test Cassette (Swab), COVID-19 Antigen Test Kit, SARS COV 2 Variant Test Kits Sample type Throat OR nasal swab Detection type Qualitative Method: Colloidal Gold Rapid Test Function: Diagnose Certificate: ISO9001/ ISO13485/CE Format: Cassette Sensitivity: 96.23% Specificity: 99.11% Accuracy: 98.56% Reading time: 15 minutes Packaging Details: Pouch+Box+Carton packaging (1) With our company's Logo (2) With the natural package (3) With OEM package (4) ODM

My company Marco&Micro test,based in china ,founded in 2010, is a leading manufacture of IVD manufacturers in China. We have successfully developed more than 200 detection test kits so far, like COVID-19 ,Tumor, Gene Test,Reproductive HIV, TP, ZIKA, Dengue, Malaria etc. Of course, OEM or ODM service are also available from us, also, worldwide distributors are very welcomed to discuss for win-win collaboration. whatsup:+8613814857410 sofia.zhang@hongweitest.com Our hot prevailing Covid19 product lines are: Antigen rapid test kits: saliva pen lollipop type rapid test kit Ag rapid test kit 3combo of covid19 and FluA&B rapid test Neutralizing Antibody Rapid Test Fast PCR test solution:sample release agent and Loyphilized pcr kit room temperature stock and delivery. extractor free, takes only 5mints to get RNA sample. All in one freeze-dried pcr kit ,decrease pipetting steps and lower contamination risk.

My company Marco&Micro test,based in china ,founded in 2010, is a leading manufacture of IVD manufacturers in China. We have successfully developed more than 200 detection test kits so far, like COVID-19 ,Tumor, Gene Test,Reproductive HIV, TP, ZIKA, Dengue, Malaria etc. Of course, OEM or ODM service are also available from us, also, worldwide distributors are very welcomed to discuss for win-win collaboration. whatsup:+8613814857410 sofia.zhang@hongweitest.com Our hot prevailing Covid19 product lines are: Antigen rapid test kits: saliva pen lollipop type rapid test kit Ag rapid test kit 3combo of covid19 and FluA&B rapid test Neutralizing Antibody Rapid Test Fast PCR test solution:sample release agent and Loyphilized pcr kit room temperature stock and delivery. extractor free, takes only 5mints to get RNA sample. All in one freeze-dried pcr kit ,decrease pipetting steps and lower contamination risk.

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

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.