COVID-19 antibody Testing Kit

$30.00

COVID-19 Testing Kits for SARS-CoV-2 IgM and IgG antibodies. Results displayed within 15 min. For Healthcare professionals only.

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This product can be offered to Health Care professionals only

Rapid Point of Care Test provides COVID-19 antibody screening results in 15 minutes.

APAC Security markets an IgM/IgG immunoassay screening device that measures the IgG and IgM response to SARS-CoV-2. The main benefit of this Device is for post disease screening, finding out whether a person:

  1. Has been infected by SARS-CoV-2.
  2. Has an immunological IgG/IgM-response to SARS-CoV-2

The answers to these two questions can be of significant benefit, for example aiding decisions around whether a person can return to work, travel, or socialise with other people. This can be particularly pertinent in the decision making surrounding at-risk groups, such as the immunocompromised and elderly. If used in the wider population it could also hold a role in determining the timing and extent of social-distancing measures and can help inform whether a staggered lifting of interventions can help avoid a secondary infection peak.

The test kit should not be used for diagnosis of acute COVID-19.

Intended use:

The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunoassay designed for the qualitative detection of IgG and IgM antibodies to the SARS-CoV-2 virus in whole blood, serum or plasma specimens. The Device provides an aid for identifying persons who may have been exposed to, and developed an immune response to the SARS-CoV-2 virus.

 

Each Test kit includes:

  • Test Cassette, which holds the test strip where detection of the IgM and IgG antibodies take place
  • Lancet & alcohol pad
  • Dropper/Pipette
  • Buffer solution
  • IFU/Product insert

 

Listed with TGA. ARTG Identifier 333341

The Clongene COVID-19 IgG/IgM Rapid Screen Test is listed as and IVD Class 3 in the Australian Register of Therapeutic Goods, ARTG.

 

Shelf life & Storage conditions

The Clongene COVID-19 IgG/IgM Rapid Screen Test offers two years shelf life from date of manufacturing.
Storage temperature 2ºC – 30ºC.

 

Warnings and Precautions

  • For in vitro diagnostic use only.
  • For use by professional healthcare providers only.
  • Results should not be used for diagnosis of acute COVID-19.
  • Do not use this Device as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19 but instead as information about whether a person may have been exposed.
  • Negative results do not rule out SARS-COV-2 infection.
  • Positive results may be due to past or present infection with non-SARS- CoV-2 coronavirus strains.
  • Read the Instructions for Usage before commencing the test. A link for download can be  found below.

Download Instructions for Usage

Download White paper

Watch the Video

Background

SARS-CoV-2 is a new strain of coronavirus causing the disease COVID-19 in humans. The symptoms range from a mild respiratory infection to more severe pneumonia with acute respiratory distress.

In response to an infection, the human immune system develops antibodies as a defence mechanism. Two important antibodies are IgM and IgG, where IgM develops around the onset of symptoms and IgG weeks later (see picture 1). The concentration of the IgM antibody decreases relatively quickly, while the IgG antibody remains longer. For certain viruses, the IgG remains for life[i], while for others it depletes quicker. For SARS-CoV-19, it is unknown for how long it remains in the body but comparing it with other strains of corona viruses such as SARS-associated coronavirus, the IgG antibody it may be detectable for more than six months. [ii]



Picture 1: IgG & IgM detection window[iii]

 

Use of APAC Security’s immunoassay screening device

 Due to the late and long-lasting IgG response this test kit is useful for identifying individuals that have been infected with SARS-CoV-2 and recovering from the disease COVID-19. One study has shown that our device has a sensitivity of 97.4% for detecting SARS-CoV-2 specific IgG in these patients[iv].

These findings support our view that the screening device is a helpful tool, determining whether an asymptomatic person:

  1. has been infected by SARS-CoV-2.
  2. has built up an IgG anti-SARS-CoV-2 immunology response.

Considering that other pandemics have arrived in waves, it may be useful determining whether a person has whole or partial anti-SARS-CoV-2 immunity in the event of a secondary peak occurring. For example, the Spanish Flu (1918-1919) came in three waves, wherein the second wave caused the most deaths (see picture 2), with 20-70 million deaths in total .v



Picture 2: Deaths from Spanish Flu[v]

An article in the Lancet has explained the usefulness of social distancing precautions and ‘the need to carefully calibrate their lifting to avoid second and subsequent waves of a COVID-19 epidemic.[vi] Measuring the presence of an immunological IgG/IgM-response to SARS-CoV-2 in the wider population may therefore provide useful data in regard to the susceptibility and transmissibility SARS-CoV-2 in a population. This may help influence the timing and extent of social-distancing measures and can help inform whether a staggered lifting of interventions can help avoid a secondary infection peak.

The use of this screening device for diagnosis of acute COVID-19 is not recommended. The IgM levels, despite an early onset, initially are low and may therefore be difficult to detect. A detectable IgG level develops later in time and may therefore not be useful for the diagnosis of acute disease.

 

References:

[i] Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.pdf

[ii] L-P Wu, N-C Want, X-Y Tian et. Al. Duration of Antibody Responses after Severe Acute Respiratory Syndrome, Emerging Infectious Diseases. DOI:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2851497/

[iii] World Health Organization https://www.who.int/immunization/monitoring_surveillance/burden/laboratory/manual_section1.7/en

[iv] Clongene clinical study report-covid-19 igg igm 20200305

[v] Vaccines Today. https://www.vaccinestoday.eu/stories/100-years-spanish-flu-world-ready-next-pandemic/

[vi] Prem K, Liu Y, Russel TW, Kucharski AJ, Eggo RM, et al. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. The Lancet. March 2020. DOI: https://doi.org/10.1016/S2468-2667(20)30073-6.