The Panodyne COVID-19 IgM/IgG/Neutralising Antibody Rapid Test Kit (blood sample), which has gained CE certification, is intended for Health Professional Use to help assess the body's immunity to COVID-19 (SARS-CoV-2) and effectiveness of the COVID-19 vaccine at the time of testing.
We recommend you read the Official Government Guidance regarding SARS-COV-2 Lateral Flow Tests here.
Itís quick and accurate. The point of care test uses a whole blood, serum, or plasma sample to detect the presence of neutralising antibodies, and a positive or negative result is visible within 15 minutes of testing, with an accuracy rate of up to 94%.
Each individual test kit includes 1x test cassette, 1x lancet, 1x buffer, 1x alcohol wipe, 1x results check card, 1x dropper pipette, 1x instructions, which are all located inside a sealed test kit wallet.
Whilst the test kit works very quickly, is easy to use, and test results are easy to read, the manufacturers recommend that the kit should be administered by medically trained personnel. Also, please note that if you are experiencing any COVID-19 symptoms, you must follow Government guidelines in terms of isolating and testing.
The results will inform you of the following, although please be aware that if the C line does not appear, the test is invalid.
Negative Result: Only a red line appears in the position of the card 1 control line; red appears at card 2 T line and C line. It indicates that no COVID-19 IgM, IgG, or neutralising antibody is detected in the sample.
1. Test M Line: red appears at M line and C line. It indicates that COVID-19 IgM antibodies are detected in the sample, the patient may be in the early stage of infection or currently infected. The final confirmation should be combined with clinical symptoms.
2. Test G Line: red appears at M line and C line. It indicates that COVID-19 IgG antibody is detected in the sample, the patient may be currently infected or had previous infection. The final confirmation should be combined with clinical symptoms.
3. When T line is lighter in colour than C line of Neutralising antibody, at same time IgM or IgG Positive, two conditions are satisfied at the same time, neutralising antibody is judged positive, otherwise judged negative. (Negative, the antibody level did not reach the lower limit of detection by colloidal gold chromatography platform.)
4. Test T Line: only a red line appears in the position of the C line. It indicates that neutralising antibody is detected in the sample.
Neutralising antibody (NAb) is a naturally-produced antibody as part of the immune system's response. These antibodies inhibit or destroy the influence of foreign factors that invade the body. Neutralising antibodies can be triggered by infection or vaccination, produced by B lymphocytes, and bind to antigens on the surface of pathogenic microorganisms, thereby preventing the pathogenic microorganisms from adhering to target cell receptors and preventing cell invasion.
Please note that this test is not intended for home use.
A recent article was published on the National Health Executive website about Panodyne tests which can be read here.
Panodyne sets the industry standards for unrivalled customer care and excellent client services from order to delivery, providing prompt replies and swift resolution to any queries. All Panodyne products are fully accredited and CE certified and registered with the MHRA where applicable.
With over 20 years of expertise, Panodyne is a well-established and trusted UK manufacturer with full ISO9001:2015 and ISO:13845 quality management system accreditations. Its production facilities are regulated and audited under the strictest standards to guarantee high quality consistency and product availability, while products are also independently tested by global testing agencies such as SGS and Intertek. All products and medical devices are researched, designed and formulated in the UK and tested to the highest European standards to meet all legal requirements.