Note that the MHRA’s role in approving the sale of a device does not include their evaluation of the voracity of a product.
RT-PCR Lab Testing is highly accurate, but expensive & time-consuming. Serological screening is instant and could substantially increase the effectiveness of RT-PCR by following up positive results instead of processing every single test via PCR.
- These test kits are professional, lateral-flow, pharmaceutical blood screening kits currently in use with hospitals worldwide and provide a result in just 15 minutes.
- Blood or Serum may be used and accuracy for detection of IgG/IgM antibodies is now in excess of 98.6%.
- They are certified for clinical use; at present they can only be supplied to, and used by, a medical professional.
By identifying probable positives through mass-screening, RT-PCR follow-up testing can be used more effectively and immediate action to isolate those potentially contagious and those with known contact. RT-PCR testing is time-consuming, labour-intensive and cannot provide enough capacity to resolve this crisis by itself.
Box of 25 tests with wipes & lancets –
25x Lateral Flow Test Devices, 25x Lancets, 25x sterile wipes, 25x pipettes, 1 x bottle buffer solution
(pricing decreases with quantity)
Bulk box of 40 tests –
40x Lateral Flow Test Devices, 40x pipettes,
1 x bottle buffer solution
(pricing decreases with quantity)
IMPORTANT – FOR USE BY MEDICAL PROFESSIONALS
The Government is presently most concerned that these kits do not enter the open market and into the hands of those who do not have the medical knowledge to correctly interpret the results (see “limitations” below). At present we are therefore required to obtain, prior to dispatch, the name and role of the medical professional who will be responsible for their receipt, storage and use. All kits are serialised and will be registered to the professional to whom they are delivered.
Sensitivity: IgG 100%, IgM 95.5% Specificity: IgG 98%, IgM 100% Overall Accuracy: IgG 98.7%, IgM 98.6%
These are NOT domestic “Home Test” kits – they are professional lateral flow tests,
CE certified for use by GP’s, Nurses, Pharmacists and other suitably medically-trained staff.
Terms and Conditions
- We CANNOT accept cancellations for orders once placed, nor can products be returned unless faulty.
- These are professional test kits and they are to be used under medical supervision.
- Negative results do NOT guarantee a subject is virus-free or that they will not, or cannot, contract the virus after testing.
Limitations of test: if you do not understand these limitations, please DO NOT buy these kits.
- The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to 2019-nCoV virus in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.
- The 2019-nCoV IgG/IgM Rapid Test is limited to the qualitative detection of antibodies to 2019- nCoV virus in human whole blood, serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.
- The 2019-nCoV IgG/IgM Rapid Test can not be used to differentiate if the infection is primary or secondary. No information of 2019-nCoV serotypes can be provided with this test.
- A negative or non-reactive result for an individual subject indicates absence of detectable 2019- nCoV virus antibodies. A negative or non-reactive test result does not preclude the possibility of exposure to or infection with 2019-nCoV virus.
- A negative or non-reactive result can occur if the quantity of the 2019-nCoV virus antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.
- Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
- If the symptom persists, while the result from 2019-nCoV IgG/IgM Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few days late or test with an alternative test device.
- The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.