Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit

The Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit is a lateral flow chromatographic immunoassay that is visually read (i.e., does not require instrumentation) and intended for qualitative detection of immunoglobulin (IgG) antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum and plasma (sodium citrate, sodium heparin, and EDTA).

This Test is designed to detect IgG antibodies to SARS-CoV-2, which are generally detectable in a patient’s blood several days after initial infection, although the duration for which antibodies are detectable post-infection is not well characterized. The sensitivity of the SARS-CoV-2 IgG Rapid Test Kit early after infection (< 5 days) is unknown due to the variable time to seroconversion. Currently, it is unknown how long antibodies persist following infection with SARS-CoV-2 and whether the presence of antibodies confers protective immunity.

Please note: The SARS-CoV-2 IgG Rapid Test Kit should not be used to diagnose acute SARS-CoV-2 infection or Coronavirus Disease 2019 (COVID-19).

Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 viral RNA or antigen is necessary.

The Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit is only for use under the Health Canada Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

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Device Features

  1. Greater than 98% Sensitivity and Specificity
  2. Results in 15 minutes
  3. Made in Canada
  4. No analyzer required
  5. Single-use
  6. Dynamic venture of established subject-matter experts
Illustrative product schematics - Lumivi Diagnostics’ SARS-CoV-2 IgG Rapid Test Kit

How Does It Work?

The Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test is a single-use cartridge that is individually packaged in a non-sterile foil pouch. The Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test kit contains all the reagents needed for the generation of SARS-CoV-2 IgG results. Testing begins with the Operator applying fresh or thawed (previously frozen) clinical plasma or serum sample to the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test cartridge followed by the application of the running buffer reagent.

The sample will migrate by capillary action along the test cartridge. If anti-SARS-CoV-2 virus IgG is present in the sample, it binds to the SARS-CoV-2 recombinant protein present in the sample pad to form an immunocomplex. As the immunocomplex continues to migrate, it is captured by the monoclonal anti-human IgG line (IgG).

The Test also contains an internal control line with immobilized polyclonal goat anti-rabbit IgG antibody. As the sample migrates from the conjugate pad, it will carry the rabbit IgG conjugate toward the internal control line and is captured by the immobilized goat anti-rabbit IgG antibody. If no internal control line (CON) is observed, the test result is invalid, and the sample must be retested.

The test line results are visible in the test result window at 15 minutes. A visible pinkish-purple band in the CON area, with the absence of a visible pinkish-purple band in the IgG area, indicates that SARS-CoV-2 IgG antibody was not detected, and the test result is negative. The presence of a visible pinkish-purple band at the CON area and the presence of a distinct band in the “IgG” test area indicates that SARS-CoV-2 IgG antibody was detected, and the test result is positive.

Considerations:

  • The results of the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test are not intended to be used as an aid for diagnosis of patients with suspected SARS-CoV-2 infection or for screening of donated blood.
  • The intensity of the test band is not necessarily correlated with SARS-CoV-2 antibody titre in the sample, and the results must be combined with the clinical observations, patient history, and epidemiological information.
  • The results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
  • A negative result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the sample is below the detection limit of the Test, or the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody detected by the Test.
  • False negative results can occur in elderly and immunocompromised patients.
  • Testing with a virus diagnostic technology should be performed to evaluate for active infection in symptomatic individuals.
  • A positive result may not indicate previous SARS-CoV-2 infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second serology test to confirm an adaptive immune response.
  • False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
  • The performance of this device has not been assessed in a population vaccinated against COVID-19.
  • Positive results do not discriminate between a previous infection and a response to vaccination.
  • This Test identifies antibodies to both the nucleocapsid and spike protein of the SARS-CoV-2 virus and is therefore unable to distinguish between previously infected individuals and vaccinated individuals.

The actual product may vary from the images shown. This Test has been authorized only to detect the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. The performance of the device has not been assessed on specimens from individuals who have been infected with emerging new variants of SARS-CoV-2, including the UK SARS-CoV-2 variant, SARS-CoV-2 VOC 202012/01 (B.1.1.7) or the new South Africa SARS-CoV-2 variant, 501Y.V2. This test has not been cleared or licensed by Health Canada; the test has been authorized by Health Canada under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2/COVID-19 unless the authorization is terminated or revoked sooner.

This product should only be used by a trained professional, and is not intended for home use, self-testing, or point of care use. The package insert must be read completely before performing the Test. Failure to follow directions described in the package insert may yield inaccurate test results.

Performance Characteristics

CLINICAL AGREEMENT STUDY:
Clinical patient samples serum or plasma (in EDTA, sodium heparin, or sodium citrate) samples were collected from 286 subjects for which 57 COVID-19 positive patients confirmed by an FDA authorized SARS-CoV-2 PCR test and 229 subjects were negative for SARS-CoV-2 prior to December 2019 (pre-pandemic). Testing of the clinical samples using the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit was conducted at International Point of Care, Toronto, Ontario, Canada. The samples were randomized and blinded.

Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test - Results

Days from diagnosis to sample retrieval Number of samples tested Total IgG antibody positive results Total IgG antibody PPA 95% CI*
0-7 days 1 1 - -
8-14 days 12 12 - -
≥15 Days 43 42 - -
Unknown 1 1 - -
Total 57 56 98.2% 90.7%
99.7%
Number of Samples Tested Negative Results Overall NPA
229 225 98.2% (95.6%, 99.3%)

Clinical Specificity (Negative Percent Agreement-NPA)

Frequently Asked Questions

  • Who can access/purchase these kits?

    Initially, these kits will be made available within the Canadian medical/diagnostic community with the expectation they would be administering the tests. Primarily they will be marketed to Federal and Provincial Public Health Offices, hospitals, universities, and private and public labs.

  • What is the difference between PCR, antigen and antibody testing?

    Unlike direct detection methods such as PCR or antigen detection tests that detect acutely infected persons, antibody tests help determine whether the individual was previously infected. Serologic assays do not replace direct detection methods as the primary tool for diagnosing active SARS-CoV-2 infections, however they do have important applications in monitoring and responding to the COVID-19 pandemic.

    Although serologic tests should not be used at present to determine if an individual is immune, the tests can help determine the proportion of a population previously infected, and the degree to which they may have a level of immunity.

  • What is the difference between IgM and IgG antibody responses?

    IgM is the first antibody to appear and represents signs of recent infection. IgG is the longer term response which remains in the body after convalescence (recovery).

    Adapted from other sources.

  • What is the difference between an Antibody (Serology) Test, Molecular (PCR) Test, and an Antigen Test?

    Antibody Test (SerologicalTest) Molecular Test (PCR Test) Antigen Test
    What are other names of the test? Serological test, blood test Diagnostic test, PCR test, RT-PCR test, Nucleic acid amplification test (NAAT) Diagnostic test, rapid antigen test
    What is the sampling method? Finger stick or blood draw Nasopharyngeal (the part of the throat behind the nose), nasal or throat swab, saliva Nasopharyngeal (the part of the throat behind the nose) or nasal swab
    How fast are the results? Some are as fast as 15 minutes including the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit, most are 1-3 days Same day or up to a week Some are fast (15 - 30 min), depending on the test
    Are other tests required? Sometimes a second antibody test is needed for accurate results Typically highly accurate and usually does not need to be repeated Typically administered by public health authorities Positive results are usually highly accurate, but false positives can happen Negative results may need to be confirmed with a molecular test
    What does this test show? Shows if you’ve been infected by COVID-19 in the past Diagnoses active COVID-19 infection Diagnoses active COVID-19 infection
    What can’t the test do? Diagnose active COVID-19 infection at the time of the test, or indicate that you do not have COVID-19 Show if you’ve been infected with the COVID-19 at some point in the past Antigen tests are more likely to miss an active COVID-19 infection compared to molecular tests Your healthcare provider may order a molecular test if your antigen test shows a negative result but you have symptoms of COVID-19
  • How is serology testing used in pandemic response?

    COVID-19: Integrated Approach to Pandemic Response