COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) (A122152)

Nom du produit
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold)
Description du produit
Buy our COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) qualitative immunoassay for the detection of novel SARS-CoV-2 IgM + IgG antibodies in human whole blood, serum or plasma in vitro. This COVID-19 rapid test is a lateral flow assay that displays results after 10 minutes.
Principe du test

COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) is a qualitative membrane-based immunoassay for the detection of antibodies against SARS-CoV-2 antigens in whole blood, serum or plasma. This test can aid in determining whether or not a subject has been exposed to the novel SARS-CoV-2 coronavirus, which causes the disease COVID-19.

When the mixed sample and buffer solution is added to the sample well, the solution migrates up the test membrane by the capillary effect. If there are anti-SARS-CoV-2 antibodies in the sample, these bind SARS-CoV-2 antigens conjugated to colloidal gold, which are present on the membrane; these migrate together up the membrane to the test line regions. Mouse monoclonal anti-human IgG antibodies are coated on the IgG test line, and these capture any IgG antibodies in the sample, so that capture antibody-sample IgG antibody-antigen-colloidal gold complexes accumulate at the IgG line. Similarly, mouse monoclonal anti-human IgM antibodies coated on the IgM test line can capture any IgM antibodies present in the sample, so that capture antibody-sample IgM antibody-antigen-colloidal gold complexes accumulate at the IgM line. The accumulation of colloidal gold produces a visible line, indicating a positive result for IgG and/or IgM. If the specimen does not contain antibodies to COVID-19, no colored line will appear in either of the test line regions, indicating a negative result. The test results should be read after 10 minutes.

To serve as a procedural control, a colored line will always appear in the control line (C) region, indicating that the proper volume of specimen has been added and membrane wicking has occurred. If the control line is absent, the result is invalid, and should be repeated with a new sample and new cassette.

Type d'échantillon
Whole blood, serum or plasma.
Composants

COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains:

  • 1 x Instructions for Use Manual
  • 40 x Test Cassettes
  • 1 x Buffer
  • 40 x Dropper
Stockage
Store at room temperature (2-30°C). Shelf life is 18 months.
Notes générales

Clinical Performance:

The in vitro diagnostic reagents used in the test are compared with the clinical diagnostic criteria of new coronavirus pneumonia to verify the clinical performance of this product. The enrolled cases were suspected cases of new coronavirus infection, a total of 1,585 cases, including 421 confirmed cases and 1,164 excluded cases. A comparative study was performed using in vitro diagnostic reagents for testing and the clinical diagnostic criteria of new coronavirus pneumonia. The test results show that the product has a clinical sensitivity of 98.81% (95% CI: 97.25%, 99.61%) and a clinical specificity of 98.02% (95% CI: 97.05%, 98.74%). In addition, 203 subjects received homologous serum / plasma and whole blood specimens (125 of which were positive and 78 were negative) for comparative tests. The results show that the product is based on the serum / plasma test results, and the consistency rate of the whole blood test results is 96.85% (95% CI: 95.87% to 97.60%). After preliminary evaluation, it is basically confirmed that the clinical performance of COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) can meet the emergency use requirements of the epidemic.

Interfering Substances:

1. When the bilirubin concentration is = 250 µmol/L, the hemoglobin content is = 9 g/L, the triglyceride content is = 15 mmol/L, the rheumatoid factor content is = 80 IU/mL, and the anti-nuclear antibody (ANA) titer is = 1: 240, anti-mitochondrial antibody (AMA) = 80 U/mL, and mouse IgG content = 1000 µg/mL, it will not interfere with the detection results of this product.

2. Histamine hydrochloride, alpha-interferon, zanamivir, ribavirin, oseltamivir, peramivir, lopinavir, ritonavir, abidol, levofloxacin, azithromycin, Ceftriaxone, meropenem, and tobramycin have been validated to have no effect on the test results of this product.

Cross Reactivity: This COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) does not cross react with positive samples of parainfluenza virus antibody, influenza A virus antibody, influenza B virus antibody, chlamydia pneumoniae antibody, mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitis B surface antibody, type C Hepatitis virus antibody, treponema pallidum antibody, human immunodeficiency virus antibody, EB virus antibody, measles virus antibody, cytomegalovirus antibody, enterovirus 71 antibody, mumps virus antibody, chicken pox-zoster virus, and HKU1 virus antibodies, OC43 virus antibodies, NL63 virus antibodies, and 229E virus antibodies (the other common coronavirus strains).

Further Information:

If you require any further information, then please do not hesitate to contact us by email, telephone, or live chat. Our technical support email address is technical@antibodies.com.

Avertissement
Ce produit est uniquement destiné à la recherche. Il n'est pas destiné à un usage diagnostique ou thérapeutique.
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