A rapid test for the detection of COVID-19

The COVID-19 IgG and IgM Rapid Test is used for the qualitative detection of SARS-CoV-2 antibodies in whole blood, serum, or plasma. The procedure is easy to administer and offers reliable results at 10 minutes that remain valid for 20 minutes.

Confident COVID-19 Results:

  • Fast results in 10 minutes
  • Easy to use and highly accurate
  • 20 tests/case
  • Prompt shipping and delivery

Easy to use procedure

Kit Contents Include:

  1. Test cassette
  2. Desiccant, buffer, alcohol swab
  3. Sterile lancet
  4. Disposable capillary
  5. Package insert/procedure guide

Easy, Efficient & Accurate
Screening Device for COVID-19

  • COVID-19 Positive/Negative Results in 15 Minutes
  • Works with Fingerstick, Whole Blood, Serum or Plasma
  • Increased Screening with IgM and IgG Antibody Detection
  • Ideal High-Volume Screening Device to Complement Nucleic Acid Tests
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Figer stick/ Whole bloode testing procedure

Steep 1

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Collect 20ul whole blood and add sample to the sample well on the test.

Steep 2

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Place 2-3 drops of buffer into the sample well.

Steep 3

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Wait 15 minutes.

Steep 4

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Read results.

CLINICAL SENSITIVITY, SPECIFICITY & RELATIVE ACCURACY

IgM/IgG Rapid Test

VALUE
(CI 95%)
Clinical Sensitivity

97.5%

(85.5% ~ 99.8%)
Clinical Specificity
100%
(95.3% ~ 100%)
Relative Accuracy
99.2%
(95.5% ~ 99.9%)

Frequently Asked Questions:

  1. What is the COVID-19 IgM-IgG Rapid Test?

    W.H.P.M. Inc.’s Covid-19 IgM-IgG Rapid Test is a lateral flow immunoassay used to qualitatively detect both IgG and IgM antibodies to SARS-COV-2 virus in human whole blood, serum or plasma.

  2. How quickly can the COVID-19 IgM/IgG Rapid Test yield results?

    Results can be interpreted at 10~15 minutes after sample and buffer are combined in the cassette sample well. 

  3. How does the COVID-19 Rapid Test work?

    The test strip uses a colloidal gold recombinant novel coronavirus antigen and a quality control antibody colloidal gold marker. The strip has the follow detection lines:

    • IgM - is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody.

    • IgG - is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody.

    • C- The quality control antibody is fixed on the C (Control) line.

  4. ow accurate is COVID-19 IgG/IgM Rapid Test Device?

    The clinical sensitivity is 97.5% and clinical specificity is 100% when compared to RT-PCR. The relative accuracy rate is 99.2%.

  5. Can the device be frozen for long-term storage?

    The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use. The advised storage is 2-30⁰C / 36-86⁰F.

  6. What is the significance of the various test results?

    • IgM presumptive positive = Indication of an early adaptive immune response to SARS-CoV-2 infection.

    • IgG/IgM presumptive positive = Indication of an adaptive immune response to SARS-CoV-2 infection that has been ongoing for more than 10~14 days.

    • IgG presumptive positive= Indication of later-stage or recovered SARS-CoV-2 infection.

    • Positive = All positive results should be confirmed with a secondary laboratory based serological antibody test. 

    • Negative = A medical professional should observe symptoms and epidemiology of patients to rule out the possibility of a false-negative result. Retesting should be considered if symptoms appear or persist.

  7. What is the alternative to using this rapid test?

    The Covid-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of this test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.

  8. What are the benefits of using this type of Rapid Test?

    • Urgency – The Covid-19 IgM/IgG Rapid Test can provide presumptive qualitative results onsite in a matter of minutes.  Providing healthcare workers with more information at critical moments in the patient's care.

    • Volume – Low-cost fast turn-around screening of asymptomatic/recovered individuals for antibodies to SARS-CoV-2.

    • Adaptive Immune Response Screening – Asymptomatic or recovered individuals can be screened with the Covid-19 IgM/IgG Rapid Test in conjunction with approved nucleic acid tests or laboratory-based serology tests to confirm recovery and the existence of infection fighting IgG antibodies in the bloodstream.

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