US FDA approved test kit 93.3% sensitivity in confirming COVID-19 cases. Nasopharyngeal test We have OTG and production deals
[Intended Usage] This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites. [Storage Conditions & Validity] 1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box. 2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times. 3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period. [Applicable Instruments] 1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument. 2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support. NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels. [Sample Requirements] 1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices. [Test Results Interpretation] 1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements. 2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition. 3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample. [Product Performance Index] 1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%. 2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%. 3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL. [CE Mark Registration No.]: RPS/499/2021. [EC REP.]: CMC MEDICAL DEVICES & DRUGS S.L. C/ Horacio Lengo n18, C.P 29006, Milaga, Spain.
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.
Our covid-19 antigen saliva test and covid 19 ag swab test already got Germany BFARM number and passed PEI test, and antigen nasal test has been registered on EU common list, hope to cooerate with your esteemed company, self testing is on progress. Hope to cooperate with your esteemed company, and we got very good feedback from many clients, promise you high quality.
Covid Ab IgG/IgM Ab Whole blood test device Covid Antigen Ag swab rapid test card Covid Antigen Ag saliva rapid test card
gg/igm double antibody is 15 minutes out of the accuracy of more than 90% or even up to 98%COVID 19 diagnostic kit is used for the qualitative detection of new coronavirus (2019-nCoV) antibodies in human whole blood, serum and plasma. Coronavirus (CoV) belongs to the order Nestivirus, Coronaviridae, and divided into three genera: �±, �², and �³. The alpha and beta gene are only pathogenic to mammals. The gamma gene mainly causes bird infections. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route. There have been seven types of human coronavirus (HCoCoV and 2019-nCoV), which are important pathogens of human respiratory tract infection.Among them, the new coronavirus (2019-nCoV) was found for 2019 cases of viral pneumonia in Wuhan. The clinical manifestations are systemic symptoms such as fever, fatigue, dry cough, dyspnea, which can quickly develop into severe pneumonia, respiratory failure, acute Respiratory distress syndrome, toxic shock, multiple organ failure, severe acid-base metabolism disorders and even life-threatening. 2019-nCoV Antibody Diagnostic Kit uses the principle of immunochromatographic method to qualitative detect the coronavirus (2019-nCoV) antibody in human whole blood, serum and plasma. It is used for clinical diagnosis of primary infection or secondary infection of new type of coronavirus infection pneumonia.
Nasal- antigen test kit
The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers. Kit Includes 20 Test Devices 20 Assay Buffer 20 Extraction Vials and Caps 20 Specimen Collection Swabs 1 Positive and 1 Negative Control Swabs 1 Instructions for Use
We supply: COVID-19 tests Tests: COVID-19 IgM COVID-19 IgG COVID-19 Antigen Rapid Test COVID-19 A+B.
CORONAVIRUS (SARS COV-2) ANTIGEN DETECTION KIT - Price 2.99 USD ONLY FOB Netherlands Remaining Qty: 60,000 pcs
Standard Q Covid 19 Ag is a rapid chromatographic immunoassay for the qualitative detection of antigens specific to SARS-CoV-2 in swab samples collected from a human nasopharynx. Fast results within 15~30 mins Easy to useSpecimen : Nasopharyngeal swab All necessary reagents provided & no equipment needed
500k Covid consumer selftests from Acon Flowflex The Acon Biotech Flowflex SARS-CoV-2 antigen test is a self-test for the detection of the COVID-19 antigen in human nasal swabs. The nasal swab only needs to be inserted 2.5 cm deep into the nasal cavity and the test results can be read in 15-30 minutes. This self-test is easy to use for consumers. With the CE0123 status, Acon Flowflex received, these tests are automatically allowed to be sold to consumers throughout Europe.
We offer antigenic tests saliva and nasal. Product free of EU customs clearance. Shipment according to quantities averages 2-3weeks.
Manufacturer: Shanghai LiangRun Biomedicine Technology Co.,Ltd. Certificates: CE(EU), MHRA(UK), HSA(Singapore), MDA(Malaysia), TSE(Turkey), DIGEMID(Peru), Luxus Medical(Germany) , FDA(US), EUA(US, Registering) FOB: 10m, 4.5usd
Choice of nasopharyngeal swab: The main indicators of clinical evaluation of swab performance are the absorption capacity and release capacity of the swab to the target sample at the sampling site. Nylon flocking swabs are made of fine nylon fibers adhered to a plastic rod. Compared with traditional cotton swabs, the adsorption surface is significantly larger, which is conducive to the adhesion and release of pathogenic microorganisms. The ability of nylon flocking swabs and traditional rayon cotton swabs to recover and release known microbial inoculums (spiked samples) confirms that nylon flocking swabs have the ability to release cells, microorganisms, viruses and other microorganisms Significant advantages. Compared with traditional rayon cotton, nylon flocking swabs or foam swabs have a significant advantage in the virus recovery rate in the screening of nasal cavity carrying MRSA virus. For the choice of virus preservation solution: non-inactivated preservation solution and inactivated preservation solution.
The current test kit is based on specific antibody antigen reaction and immunoassay technique. The test card contains a gold labeled novel coronavirus N protein monoclonal antibody p re coated on the binding pad and a paired novel coronavirus N protein monoclonal antibodies fixed in the test line (T) and corresponding antibodies in the quality control line (C). During the test, the N protein in the specimen binds to the gold-labeled nove lcoronavirus N protein antibody pre-coated on the binding pad, and the conjugate moves upward under the capillary effect, and then is trapped by N protein monoclonal antibody conjugate fixed in the Test Line (T). The higher the N protein content in the specimen, the more conjugates are trapped, and the darker the color of the Test Line (T). If there is no novel coronavirus in the specimen or the virus content is below the detection limit, no colour appears in the Test Line (T). A purple red band will app ear in the Control Line (C) regardless of whether there is a virus in the specimen. The purple red band that appears in the Control Line (C) is the criteria for determining whether there is enough specimen and whether the chromatography process is normal.
Covid Antigen Ag swab rapid test card, Sensitivity: 96.17%; Specificity: >99.9%; Accuracy: 98.79% Big quantity, low price is available.
Covid 19 Rapid Antibody Test Kits IgG IgM Brand HEALGEN 98% Accurate 10 Minute Response
NanoCare COVID-19 Antigen (Ag) Kit is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.
SARS-CoV-2 ANTIGEN SPEED Test Strip, a rapid, accurate and simple way of diagnosing SARS-CoV-" virus infection in human Blood within 15 to 20 minutes. Antigen schnell Test COVID CE-MArked Results within 15-20 minutes SIMPLE FAST Sensitivity: 91.27% (with 95% confidence interval 84.92% - 95.56%) Specificity: 100% (with 95% confidence interval 99.22% - 100%) BfArM Listed (German Government)
