The information on this page is for AHPRA registered medical practitioners only. 

PRODUCT INFORMATION

COVID CONFIRM

COVID-19 RAPID
IgG/IgM Antibody Test

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 novel coronavirus in human whole blood, serum or plasma. 

PRODUCT DETAILS:

  • Utilizes human whole blood, serum, or plasma
     

  • Used in rapid, qualitative and differential detection of IgG and IgM antibodies
     

  • Dual band results for simple interpretation
     

  • Multivariable analysis of immunoglobin IgG & IgM
     

  • Delivers clinical results between 2 and 10 minutes at the point-of-care
     

  • Visual interpretation of results
     

  • Room temperature storage or refrigerated (2-30⁰C)
     

  • Procedural internal control included
     

  • Buffer included
     

  • No special equipment needed

Product Code:  OD-COVID19-RAP

  

ARTG Registration No.  334505

Specificity: IgG/IgM 100%

Sensitivity: IgG/IgM 91.96%

Specimen: Whole Blood, Serum, Plasma

Time to Results: 10 minutes

Shelf Life: 24 months from the date of manufacture

Only available for supply to medical practitioners, pathology laboratories, healthcare professionals in aged care and residential facilities.

ONLY AVAILABLE FOR PURCHASE AND ADMINISTRATION BY AHPRA REGISTERED HEALTH PRACTITIONERS - NOT AVAILABLE FOR PERSONAL/PRIVATE TESTING.

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19 antibodies. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.

IgG/IgM antibody tests can be supplied for rapid screening of carriers of the virus that are symptomatic or asymptomatic. The test is ideally suited for hospitals, clinics and test laboratories. 

Instructions for Use:

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
 

2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):

a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
 

3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
 

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

  • Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
     

  • Positive Result, IgM only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.
     

  • Positive Result, IgG only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.
     

  • Positive Result, IgG and IgM: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.

SEE CHART BELOW TO ASSIST WITH INTERPRETATION

What is coronavirus and how is it spread?

The term coronavirus refers to a family of viruses, some causing illness in people and others that circulate among animals. The SARS-CoV-2 strain was first identified in Wuhan, China in December 2019. Public health officials have identified the source of this virus in bats and are investigating its spread from animal to human and human to human. It is typically spread by respiratory droplets from coughs or sneezes, similar to the way flu and other respiratory viruses spread.

What is the incubation period for COVID-19?

Infectious disease experts have determined that symptoms can begin within 14 days of initial exposure to the virus.

What are the primary symptoms?

Primary symptoms are:

  • Cough

  • Fever

  • Shortness of breath

If you have recently traveled to China or other parts of the world where outbreak is prevalent, or been in close contact with someone who traveled to those countries and have any of the above symptoms, contact your healthcare provider right away.

TO ORDER PLEASE PHONE 1300 667 107.

SUPPLY IS ONLY AVAILABLE TO MEDICAL PRACTITIONERS.

High stock turnover means we are able to provide product with a
long shelf life.
Expiry dates are generally 12-24 months from the date of purchase.

Onsite Diagnostics Pty. Ltd.

Unit 3, 59 Township Drive,

BURLEIGH HEADS, QLD 4220

Email: info@onsitediagnostics.com.au   or   orders@onsitediagnostics.com.au

Web: www.onsitedrugtesting.com.au