Lateral Flow Rapid Antibody Test

COVID-19 (SARS-CoV-2)
IgG/IgM Dual Antibody Test Kit In Vitro

Application: For detecting both IgM and IgG antibodies of human infected by COVID-19 virus.

Assay Format: Basically, this Immunochromatographic Assay can simply described by this formula:
Ag + Ab + Ab2 = Ag – Ab – Ab2.

Intended Use: As an aid for diagnosis of SARS-CoV-2 infection. Following FDA policy during Emergency Use Authorization submission review EUA201085 processing use only.

Ag=Antigen, Ab=Primary Antibody, Ab2=Secondary Antibody

COVID-19 (SARS-CoV-2) IgG/IgM Dual Antibody Test Kit developed and manufactured by dAb ImmunoTech, Inc.

Background

The human body can produce multiple type of antibodies, mainly IgM and IgG, following infection from virus, bacteria, and other pathogenic organisms. IgM antibodies are produced as the first line of defense to viral infections. IgG antibodies are more adaptive and maintain a high specificity and affinity response toward long term immunity and immunological memory. The presence of IgM antibodies produced in response to COVID-19 infection indicate a recent exposure while the presence of IgG antibodies indicate a later stage COVID-19 infection. Therefore, detection of both COVID-19 IgM and IgG antibodies is an effective method in diagnosis of the infection, as well as in providing information on the stage of disease.

Assay Principle

The COVID-19 (SARS-CoV-2) IgG/IgM Dual Antibody Test Kit is a qualitative membrane-based immunoassay for the detection of both human IgG and IgM antibodies to SARS-CoV-2 antigens in human serum, plasma and whole blood specimens. During the assay, the COVID-19 IgG and IgM antibodies in the specimen bind with SARS-CoV-2 viral antigens precoated on the membrane inside the test cassette forming an antibody/antigen complex. The complex then migrates up the membrane by capillary action and through the detection window. When the complex reaches test lines IgG and
IgM it reacts with pre-mobilized anti-human IgG and IgM. If the specimen contains IgG and IgM antibodies to SARS-CoV-2, red colored lines appears in the IgG and IgM test lines (See Fig. 1). If neither antibody is present in the specimen, no color is displayed.

The test cassette also contains a quality control line (C). A red color on the C line indicates the sample has been transported properly through the membrane regardless of the presence of any antibodies. No color on the C line indicates that the test results are invalid and a new test cassette is required.

Assay Workflow

As shown in following schematic illustration, there are four simple and straightforward steps for doing the test.  

Fig.2. Schematic illustration of testing procedure for COVID19 IgG/IgM Dual Antibody Kit

Step 1. Before use check the test kit contents to insure the foil pouch is not damaged and the Specimen Diluent bottle is not leaking. Bring the Test Cassette and the Specimen Diluent to room temperature before starting the test. The Test Cassette should be used within 1 hour after remove from the foil pouch. The kit is now ready for use. Obtain 20μL of fingerstick whole blood specimen using the enclosed capillary sampler.

Step 2. Apply 10μL of the specimen to the specimen well of Test Cassette. 

Step 3. Add 2 drops (80 μL) of Specimen Diluent to the specimen well, avoid air bubbles. 

Step 4. Wait 10 minutes. The results can be read visually in the detection window (See Fig. 1 above). All wastes should be treated as potential infectious materials.

Product Detail

Product IDSizeAvailabilityInstructionsPrice
Kit-LFI -001-2525IFU
Kit-LFI-001-5050IFU
Kit-LFI-001-100100IFU
Kit-LFI-001-BBulkIFU
Kit-LFI-001-OOEMIFU

Order

Purchases are available online, via email, and by phone.

  • Online ordering is available on our website. Click here to request a quote.
  • By phone or via email below
In USA:
Tel: 470-556-1748
order@dAbImmunoTech.com
International:
order@dAbImmunoTech.com

Advantages

The dAb ImmunoTech COVID-19 (SARS-CoV-2) IgG/IgM Dual Antibody Test has several significant advantages:

  • Simple Point-of-Care Test: One drop of specimen blood is conveniently added to the sample well at the point of care
  • Rapid: Each test requires less than 10 minutes of hands-on time
  • Flexible: The test works directly with whole blood, serum, and plasma specimens; and requires only a 10uL of sample
  • Efficient: The test simultaneously detects both IgM and IgM antibodies against COVID-19 virus
  • Cost-effectiveness: The tests are inexpensive, easily disposable, and have a low operation cost
  • No equipment required: Results can be read by eye without the need for testing instruments

Download 

Click or tap following links to see a full file. 

BrochureFlyer ManualProtocol

Related Products

Click or tap the following links to see a full file. 

Traditional ELISAOne Step ELISASandwich ELISA Reagent(Ag/Ab)

Video

COVID19 Lateral Flow KitShow entire process and procedure for how to use the kitWatch now click here

Service

See Service Section in more detail.

References

  1. Anu Haveri, et al. Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020. Euro Surveill. 2020 Mar 19; 25(11).
  2. Balmaseda A, et al. Diagnosis of dengue virus infection by detection of specific immunoglobulin M (IgM) and IgA antibodies in serum and saliva. Clin Diagn Lab Immunol (2003) 10(2):317–22.
  3. Cohen J, et al. New SARS-like virus in China triggers alarm. Science 2020;367(6475):234-235.
  4. CuiJ, et al. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbial 2019; 17: 181-192.
  5. Huang C, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 395:497–506.
  6. Huang C, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506.
  7. Katarzyna M, et al. Lateral flow assays, Essays Biochem. 2016 Jun 30; 60(1): 111–120.
  8. Laura Anfossi, et al. Multiplex Lateral Flow Immunoassay: An Overview of Strategies towards High-throughput Point-of-Need Testing. Biosensors (Basel) 2019 Mar; 9(1): 2.
  9. Mak, W.C.; et al. Lateral-flow technology: From visual to instrumental. Trends Analyt. Chem. 2016, 79, 297–305.
  10. Nadezhda A. Byzova, et al. Lateral Flow Immunoassay for Rapid Detection of Grapevine Leafroll-Associated Virus. Biosensors (Basel) 2018 Dec; 8(4): 111.
  11. Prabir Kumar Kulabhusan, et al. Field-Usable Lateral Flow Immunoassay for the Rapid Detection of White Spot Syndrome Virus (WSSV). PLoS One. 2017; 12(1): e0169012.
  12. Tanu Singhal. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020; 87(4): 281–286.
  13. Xiaowei Li, et al. Molecular immune pathogenesis and diagnosis of COVID-19. J Pharm Anal. 2020 Mar 5.