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Biolidics - Rapid test kit for COVID-19 - IgG/IgM Antibody Detection Kit (Colloidal Gold)

  • Rapid-results in 10 minutes and includes antibody detection of silent and asymptomatic recent or prior infections.
  • Compatible with venous whole blood / serum / plasma2
  • Simultaneous evaluation of IgM and IgG antibodies to SARS-CoV-2
  • Complements tests such as PCR1, used in detecting recent or prior infections

Key features

  • Rapid-results in 10 minutes and includes antibody detection of silent and asymptomatic recent or prior infections
  • Compatible with venous wholeblood / serum / plasma2
  • Simultaneous evaluation of IgM and IgG antibodies to SARS-CoV-2
  • Complements tests such as PCR1, used in detecting recent or prior infections

Principle

  • IgM Antibodies are usually produced in the early/mid stage of an initial infection, whereas, the IgG Antibodies are present in the mid/late stage of infection onwards
  • Positive result (IgG and/or IgM+) indicates recent or prior SARS-CoV-2 infection
  • Negative result indicates no anti-SARS-CoV-2 antibodies detected or suspected in the early stage (within first few days) of a SARS-CoV-2 infection

Clinical Performance

Sensitivity Specificity Conformity
91.54%
(95% CI: 86.87% - 94.65%)
97.02%
(95% CI: 94.74 % - 98.33%)
95.09%
(95% CI: 92.99% - 96.58%)

Workflow

Limitations

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out other infections in these individuals.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

Test procedure and interpretation

Results* Interpretation**
IgM +VE, IgG +VE Suspected recent infection of SARS-CoV-2
IgM +VE, IgG –VE Suspected recent infection of SARS-CoV-2
IgM –VE, IgG +VE Patient suspected to have past infection
IgM –VE, IgG –VE IgG/IgM antibodies for SARS-CoV-2 undetected OR antibody level below limit of detection

* Results should only be evaluated if the C band is present. If it is absent, the test must not be evaluated and has to be discarded. A retest of the sample will be required.

** This test is intended to be an aid in identifying patients with antibodies to SARS-CoV-2. Positive IgG and/or IgM results indicates a recent or prior infection. This test is not intended for use to diagnose acute SARS-CoV-2 infection and direct testing should be performed for diagnosis.

BiolidicsIncorporated in 2009 and listed on the Singapore Stock Exchange, Biolidics Limited (“Biolidics” or “the Company” and together with its subsidiaries “the Group”) is a precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.
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