Buy our Sets
Small BusinessNew Prices
- For 40 test kits
- £18.00€20.00$24.00 per test kit
- For 80 test kits
- £16.00€18.00$21.00 per test kit
- For 400 test kits
- £11.00€12.00$14.00 per test kit
Details about the product
Easy-to-use “All-in-one” test for the detection of anti-SARS-CoV-2 antibodies (IgM & IgG)
Each Box containing 40 test kits individually packaged in aluminium packs.
- Small Business Set
40 test kits in total
- Medium Business Set
80 test kits in total
- Large Business Set
400 test kits in total
What’s inside each box
- 40 test devices individually packaged in aluminium pouches
- 2 Buffer solutions
- Instruction leaflet
- The box does not include a Lancet (finger pricker)
Instructions and Interpretation of the results
How to read the test results
How the test works
The test works via the qualitative detection of the antibodies of IgM/IgG against novel coronavirus in serum, plasma, or whole blood.
Immunoglobulin M (IgM), found mainly in the blood and lymph fluid, is the first antibody to be made by the body to fight a new infection. The antibody of IgM against the 2019-nCoV starts to be detectable in about 3-4 days in blood of an infected patient who has no symptoms, and the level peaks in 10-14 days. The level of the IgM persists but rapidly diminishes over the next 12 weeks before it is no longer clinically detectable. The presence of IgM in a single specimen suggests that the patient has currently experienced a 2019-nCoV infection. In most cases the infection probably occurred within the preceding month. The specific IgM might have been producing for a period of 3 months.
Immunoglobulin G (IgG), the most abundant type of antibody, is found in all body fluids and protects against bacterial and viral infections. The antibody of IgG starts to be detectable in 10-14 days after infection and increases rapidly for the next 7 to 30 days and decreases slowly for almost a year.
The latent period of the virus infection is from 1 to 14 days, and the average is about 5 days. This test can detect antibodies against the 2019-nCoV from 3 days and can detect an extended period of time from 10 days +. There is a built-in control for the procedure on the card ensures that the test has been performed correctly.
The immune colloidal gold technique
The immune colloidal gold technique is used in the assay to detect antibodies of IgM/IgG against the 2019-nCoV. The main advantages of colloidal gold include the kits don’t need to be kept at room temp for minimum of 30 minutes before use and no obstruction of matrix pores. The gold nanoparticles provide protection against heat and well as extreme assay stability and improves kit shelf life (18 months). The kit uses an “immune colloidal gold technique” in the assay system which is overall more reliable and accurate technique. Whereas, standard nitrocellulose membranes may cause matrix pore blockage, especially when blood starts to coagulate.
This offer is aimed exclusively at commercial customers with appropriate specialist staff. These include: doctors, outpatient and inpatient facilities in the healthcare sector, wholesale and pharmacies, health authorities of the federal, state, communal and community associations, blood donation services, pharmaceutical companies, counseling and test facilities for particularly vulnerable groups of people.
This product is intended for professional use and not for home use. Results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection status.
A negative result may appear and not correlate with symptoms. A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result.
The box does not include a Lancet (finger pricker)
Frequently asked Questions
An antibody is a specialised protein made by the body in response to infection. When a virus infects a person’s cells, the human immune system develops targeted antibodies to fight and eliminate the virus from the body. These antibodies circulate in the blood and can be tested for. This is known as a serological test.
This test is suitable for detection of antibodies against SARS-CoV-2, in human serum, whole blood or finger prick samples. It can detect specific IgM and/or IgG antibodies that develop in response to an infection with SARS-CoV-2.
If a person has specific antibodies to SARS-CoV-2 in their blood, it suggests they have had infection with SARS-CoV-2. They may or may not have had symptoms, and they may or may not have developed the disease known as COVID-19.
There is a lag time between infection and the production of IgM and IgG antibodies. This means that whilst a positive antibody test can tell us if a person has been exposed to SARS-CoV-2, it can’t tell us if that person is currently or recently infectious.
Graph 1 shows the typical time it takes for the immune system to develop a response to infection with SARS-CoV-2 and at which timepoint the IgM and IgG antibodies become detectable. It’s important that tests kits are readily available for use and that results are interpreted by a professional who understands the timeframes of the immune system response.
When combined with the clinical picture, a positive test can aide diagnosis and subsequent management.
The antibody rapid detection test is an important tool for clinical assessment as it can quickly determine whether someone has had infection with SARS-CoV-2.
Point-of-care serology tests are a useful supplement to virus culture testing methods (like PCR and nucleic acid detection testing), which can take several hours and complex laboratory resources to generate results.
Antibody rapid detection tests help us estimate what proportion of the population have antibodies against SARS-CoV-2, and therefore may have immunity to repeat infection.
This can help manage the epidemic and assist planning for returning to work and resuming normal activities.
a) The specimens to be tested and the required reagents shall be removed from the storage condition and be balanced to room temperature;
b) The kit shall be removed from the packaging bag and placed flat on a dry bench.
a) Add specimen Serum/Plasma: The volume of one drop of the specimen dripping from the dropper we supplied is 10 μL. Take 10 μL of serum or plasma into sample well (S), and then add vertically 2 drops (about 100 μL) of specimen diluent. Whole blood: The volume of one drop of the specimen dripping from the dropper we supplied is 10 μL. Take 20 μL of whole blood to sample well(S), and then add vertically 2 drops (about 100 μL) of specimen diluent.
b) The positive specimens can be detected within 10 minutes after sample addition. Relevant verification shows that the observation of the test results will be affected if the reaction time were exceed 15 minutes (record time after sample addition), so it is recommended to read and record the test results within 10 minutes.
IgM and IgG POSITIVE
It is positive for both IgG and IgM antibodies against the 2019-nCoV if three lines appear. One colored line should be in the control line region (C), and another two should appear in IgG test line region and IgM test line region.
NOTE: The intensity of the color in the test line regions will vary depending on the antibodies against the 2019-nCoV presented in the specimen. Therefore, any shade of color in the test line region should be considered positive.
It is positive for IgM antibodies against the 2019-nCoV if two lines appear. One colored line should be in the control line region (C), and another one appears in the IgM test line region.
It is positive for IgG antibodies against the 2019-nCoV if two lines appear. One colored line should be in the control line region (C), and another one appears in the IgG test line region.
One colored line appears in the control region (C). No apparent colored line appears in the IgG or IgM test region (T).
Control line fails to appear. Insufficient sample volumes or incorrect procedures are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test card. If the problem persists, the test kit should be discontinued of using immediately and your local distributor should be contacted.