Clungene COVID-19 Antibody Testing Kit for Professional Use
COVID-19 Testing Kits for SARS-CoV-2 IgM and IgG antibodies. Results displayed within 15 min. For Healthcare professionals only.
The Clungene COVID-19 Antibody Testing Kit for Professional Use can be offered to Health Care professionals only. Please register your interest to purchase this product via our contact form below.
Rapid Point of Care Test provides COVID-19 antibody screening results in 15 minutes.
APAC Security Australia 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 to find out whether a person:
- Has been infected by SARS-CoV-2.
- Has an immunological IgG/IgM-response to SARS-CoV-2 either from;
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 process 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.
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 Clungene COVID-19 Antibody Testing Kit includes:
- Test Cassette, which holds the test strip where detection of the IgM and IgG antibodies take place
- Lancet & alcohol pad
- Buffer solution
- IFU/Product insert
The Clungene Antibody Testing Kit is listed with the TGA – ARTG Identifier 333341.
The Clungene COVID-19 IgG/IgM Rapid Screen Test is listed as and IVD Class 3 in the Australian Register of Therapeutic Goods, ARTG.
The Doherty Institute in Melbourne has published a Report regarding the APAC COVID-19 Antibody test kit
The Doherty Institute, which is a joint venture between The University of Melbourne and The Royal Melbourne Hospital has published a report regarding the APAC COVID-19 Antibody test kit. As part of the TGA listing with the Federal Government, each supplier has to provide their test kits for evaluation, where the Doherty Institute compares the reported characteristics from the manufacturer with their own testing. The Doherty Institute finding was that the APAC COVID-19 antibody test kit “met, or where within the acceptable confidence interval for, the performance characteristics as reported by the manufacturer in the instructions for use (IFU)”.
The Doherty Institute used serum, sampled prior to the COVID-19 outbreak in Australia as well as on samples collected from patients with SARS-COV-2 infection confirmed by molecular testing. It is important to test the kit with serum before the outbreak in order to determine if the kit reacts to other Corona viruses and if so generate a false positive response to the specific SARS-COV-2 virus.
Naturally, it is equally important to test samples from patients with confirmed infection and more so when the IgM & IgG response appear.
As expected, the combined IgM/IgG response is limited during the first weeks post symptom onset and increase thereafter – sensitivity from all samples were 88.0%, while sensitivity post 14 days was 97.4%. Overall specificity was 98.0%.
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.
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 the Clungene 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:
- has been infected by SARS-CoV-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.
[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
[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.