Clongene’s Rapid on-Site Test provides

FOR PROFESSIONAL USE ONLY

Clongene’s Rapid on-Site Test provides COVID-19 screening results in 10 – 15 minutes

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.

Contents

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, TRIM Reference: E20-49236

The Australian Department of Health have decided to include the Clongene COVID-19 IgG/IgM Rapid Screen test, Class 3 in the Australian Register of Therapeutic Goods, ARTG. Note that under section 41FP of the Therapeutic Goods Act 1989, testing is to be conducted in conjunction with a medical or healthcare professional who can provide appropriate advice and treatment if required.

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.

Intended use

The Clongene COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human Blood/Serum/Plasma.

In response to an infection, the human immune system develops antibodies as a defense mechanism. Two important antibodies are IgM and IgG, where IgM is detectable after the onset of symptoms and IgG 1-6 weeks later. Testing for SARS-CoV-2 IgM and IgG antibodies is an effective methodology for the diagnosis and understanding of the progression of a COVID-19 infection.

Detection of the SARS-CoV-2 IgM antibody indicates an earlier stage of the infection, whilst detection of SARS- CoV-2 IgG indicates a later stage of the infection. A sample is positive if there are IgM, IgG or both IgM and IgG antibodies present. Therefore, screening for both SARS- CoV-2 IgM and IgG antibodies gives additional information on the stage of infection.

It should be noted that presence of detectable IgM and IgG antibodies during Incubation is neglectable. A negative test may therefore indicate no infection or the infection is still in the incubation or early symptoms time window.

Sensitivity and Specificity

IgM: 167 clinical specimens have been analysed with the Clongene COVID-19 Screening Test and compared with RT-PCR. IgM Sensitivity was calculated as 87.01 % and Specificity as 98.89%.

IgG: 77 patients have been analysed with the Clongene COVID-19 Screening Test during the convalescence period. IgG sensitivity was calculated as 97,40%.
(Source: Hangzhou Clongene, clinical study report COVID-19 IgG IgM 20200305).

Easy to use

  1. One droplet of blood/Serum/Plasma is added to the sample well of the Test Cassette
  2. Add 2-3 drops of Buffer Solution to the same sample well of the Test Cassette
  3. Read result between 10 – 15 minutes

Interpretation of results

Results are read from the window of the Test Cassette, which is marked from top to bottom with C, IgG and IgM;

C is a control line, which must always be present at the time of analysis. No C-line means that the test is invalid and a new test should be performed.

IgG is a Test line indicating the presence of the IgG SARS-CoV-2 antibody. A line should be read as a presumptive positive test. No line should be interpreted as a negative test.

IgM is a Test line indicating the presence of the IgM SARS-CoV-2 antibody. A line should be read as a presumptive positive test. No line should be interpreted as a negative test.