COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) (A122152) has been discontinued and is no longer available.
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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.
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains:
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.
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains:
Interpretation of Results for the COVID-19 IgG + IgM Rapid Test Kit (Colloidal Gold) (UNCOV-40)
Positive: If the control line (C) and the IgM line (M) appear, then the test is positive for anti-SARS-CoV-2 IgM antibodies. If the control line and the IgG line (G) appear, then the test is positive for anti-SARS-CoV-2 IgG antibodies. If the control line and both the IgG and IgM lines appear, then the test is positive for both IgG and IgM anti-SARS-CoV-2 antibodies.
Negative: If only the control line appears, then the result is negative, and neither type of antibody has been detected in the sample.
Suspect: A light band is an inconclusive result. The sample requires retesting, or an alternate testing method (i.e. PCR test, such as, RT-qPCR) to determine positivity.
Invalid: If no lines appear, or the IgM and / or IgG lines appear without the control line, then the results are invalid and additional testing is required. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the instructions and repeat the procedure with a new test cassette.
How to use the COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold)
This graphic is only intended for use as an illustrative guide. Please read the data sheet carefully before the first use for full instructions.
Since its first discovery in December 2019, the global coronavirus disease 2019 (COVID-19) pandemic caused by the novel coronavirus (SARS-CoV-2) has been posing a serious threat to human life and health. Diagnostic testing is critical for the control and management of the COVID-19 pandemic. In particular, diagnostic testing at the point of care (POC) has been widely accepted as part of the post restriction COVID-19 control strategy. Lateral flow assay (LFA) is a popular POC diagnostic platform that plays an important role in controlling the COVID-19 pandemic in industrialized countries and resource-limited settings. Numerous pioneering studies on the design and development of diverse LFA-based diagnostic technologies for the rapid diagnosis of COVID-19 have been done and reported by researchers. Hundreds of LFA-based diagnostic prototypes have sprung up, some of which have been developed into commercial test kits for the rapid diagnosis of COVID-19. In this review, we summarize the crucial role of rapid diagnostic tests using LFA in targeting SARS-CoV-2-specific RNA, antibodies, antigens, and whole virus. Then, we discuss the design principle and working mechanisms of these available LFA methods, emphasizing their clinical diagnostic efficiency. Ultimately, we elaborate the challenges of current LFA diagnostics for COVID-19 and highlight the need for continuous improvement in rapid diagnostic tests.
