Sars Cov 2 Igm Igg Antibody Test Kit Suppliers and Manufacturers

Corona viruses are enveloped RNA viruses that are distributed broadly among humans, birds and other mammals, that cause respiratory, enteric, hepatic, and neurologic disease. SPECIFICATIONS: Whole blood/serum/plasma may be used for testing. Results available in only 15 minutes. Easy to use. Result can be read visually. No need for an analyser. Cost effective method for assisting in screening COVID-19 disease.

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.

[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.

TEST KIT FOR THE SARS-COV-2 ALSO KNOW AS THE NOVEL CORONA VIRUS 2019 (NCOV-19).

Product Details: Number of Reactions(Preps)/Kit ; 25 Brand : Cellex Test Method : (SARS-CoV-2) IgM/IgG Rapid Antibody Result Time (Rapid Kits) 30 minutes Time To Result 15 mins Cat. No : 5513C COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19

We can supply SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Imunoassay), to anywhere in the world, for more details please visit our

SARS-CoV-2 Urine Antibody Test (UR-CoV-2). This is a urine test for the rapid and qualitative detection by immuno chromatography (Lateral Flow Method) of IgG (Immunoglobulin G) SARS -CoV-2 antibodies. This autotest is simple to use and gives a result in 5 to 10 minutes. It helps you to know the state of your immunity (antibodies IgG) to this new virus. Urine must be collected in the morning when you get up. 3. Packaging specifications: 1) Presentation: - one test per bag - 10 bags / box or 20 bags / box or 40 bag / box 2) Urine collector (10 or 20 or 40 /box) 3) Instructions for use: one copy is included in the box.

This product is the rapid testing of COVID-19, the result come out within 10 minutes.

1. Nasopharynx swab specimen, non-invasive 2. Very simple to use 3. Convenient, no devices required 4. Rapid, results within 20 minutes 5. Cost-efficient 6:Listed on German BfArm ,got approval by PEI Clinical report from local CDC Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.

colloidal gold method

Product Description COVID-19 Ab Test - Boditech Price of product ( USD price or FOB price) : USD6.5/test FOB Korea Product origin : Republic Of Korea HS code 3822.00.1020 Key Specifications/Special Features : * Easy to use with small device * Fast and precise result (10mins) * Room temperatue storage * Anti-viral IgG / IgM test * Automated (AFIAS) or manual (iChroma II) platform * Assay type: TRFLFA*, IgM/IgG * Sample type: Whole blood / serum / plasma * Sample prep / extraction: Fingertip blood(C-tip)/ tube blood Certificates FDA, CE, ISO13485, FSC - MFDS * MFDS: Ministry of Food and Drug Safety of Korea Minimum Order Size and Packaging details : * MOQ: 1,000 tests * Packing: 24kits/box (AFIAS-1/6) 25kits/box (ichroma II)

COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit Principle: based on Colloidal Gold Method, to detect COVID-19 IgG/IgM Antibody in serum, plasma, whole blood qualitatively. Easy to operate, results can be obtained in 15 minutes. Component: 25 tests cassttes/ 25 dropper/ 25 tubes of dilution buffer/25 Alcohol pad/ 25 Lancet/ 1 manual Certificate: CE, ISO13485, ISO9001

Sensitivity: 95.06% Specificity: 99.62% Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation. General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision. Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals. Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .

Product Name : COVID-19 SARS-CoV-2 IgG/Ig Manti body Test Kit (Colloidal Gold) with CE and FDA Product Description : shouldbenoobviousgap.The inner teststrip shouldbefirmlyattachedwithoutwaggle.Thediluentshouldbeclearandfreeof foreignmatter. 1.2 Size:thesizeoftheinnerstripshouldnotbelessthan2.5mm. 1.3 Liquidmigrationspeedshouldnotbelessthan10mm/min. 1.4 2. Minimum detection limit The minimum test limit reference products S1 should be negative, S2 and S3 should be positive. 3. Negative compliance rate:5 pieces of negative referenceproducts of the test companyshall be all negative, with a negative compliancerateof100%. 4.Positivecompliancerate:5pieces of positivereferenceproducts,eachreferencetestonetimes andshallbeallpositive,with apositivecompliancerateof 100%. 5.Repeatability:Test1pieceoftheenterprisepositivereference,testit10times,thecolor shouldbeconsistentandallpositive. 6.Specificity 6.1 Cross Reaction: This product do not cross-react with the positive specimens including vice influenza virus antibodies, influenza a virus, influenza b virus antibodies, pneumonia chlamydia, mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitis b surface antibody, hepatitis c virus antibody, treponema pallidum antibody,human immunodeficiencyvirus (HIV) antibodies, EBvirus antibody,measles virus,CMVantibodies, enterovirus type71,mumpsvirusantibody,varicella- zostervirus. 6.2 Thereisnocross-reactionbetweenRF,ANAandAMA. 6.3 Interferingsubstance: (1) When bilirubin concentration 250 mol/L, hemoglobin content 9g/L, triglyceride content 15mmol/L, content of rheumatoid factor 80IU/mL, titer ofANA1:240, anti-mitochondrial antibody (AMA) 80U/mL, content of mouse IgG1000g/mL,therewillbenointerferencewiththetestresultsofthisproduct. (2) The commonly used antiviral drugs epiztin acid (4mg/L), ribavirin (40mg/L), interferon (200mg/L), oseltamivir (30mg/L), abidol (40mg/L), levofloxacin (200mg/L), azithromycin (100mg/L), ceftriaxone (400mg/L), meropenan(200mg/L) hasnointerferenceinthedetectionofthisproduct. 7. Hook effect: No hook effect was found inthe test results of this product within the titer range of clinically positive samples ofthenovelcoronavirusantibody. 8. The minimum detection limit and reproducibility of 10 samples of clinically positive serum of COVID-19 novel coronavirus werestudied. Product origin : China Key Specifications/Special Features : CE FDA Hospital professional testing and use, family and individuals can not use Minimum Order Size and Packgaing details: MOQ:10000pieces 25pieces/box box size:15*14*6.5cm ,150g/box 100boxes /CTN CTN Size 72*62*36cm 21KG(without lancet and alcohol cotton)

This SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) is intended for use by laypeople in the home environment. The application is carried out using saliva as a sample. - Patient-friendly - Saliva as a sample - User-friendly - simple and time-saving thanks to pre-filled sample tubes - Reliable - meets the valid requirements of the RKI and the BfArM and was evaluated by the Paul Ehrlich Institute PEI - Result within 15 minutes - All necessary materials in the pack contain specifications: - Colloidal gold immunoassay - Sensitivity: 95.51% (7 days after onset of symptoms) - Specificity: 99.45% - Sample material: saliva - Pack size: 1 test - Storage: 2 - 30 C - Shelf life: 18 months - Special approval for laypeople by the BfArM (BfArM GZ: 5640-S-032/21) - Specifications positively evaluated by the PEI (Paul-Ehrlich-Institut) Permitted users: Self-test for laypeople Scope of delivery per pack: 5x test cassette packed in foil pouch 5x sample tubes with extraction buffer 5x sterile disposable swabs 1x instructions for use 1x brief instruction