CoronaSafe Test Kit - 40 Kits
CoronaSafe™ Test Kit – 40 Kits
Fast results in 10 minutes with a single drop of blood from finger-prick
The first combined IgM/IgG screening test backed by a clinical trial of 1,585 patients
98.02% clinical specificity & 96.85% consistency
Registered with MHRA for sale in the UK for professional use
Covid-19 Antibody Screening Test
CoronaSafe™ is a finger prick COVID-19 antibody screening test which provides detection of COVID-19 infection from a single drop of blood within 10 minutes. It’s been proven in extensive clinical trials of 1,585 patients during the recent outbreak, with 98.02% clinical specificity, 98.81% sensitivity and 96.85% accuracy.
CoronaSafe™ detects the presence of two key IgG & IgM immunoglobin biomarkers of COVID-19. IgM levels in blood rise quickly and are detectable from 3+ days after infection with IgG levels rising after 7 days. CoronaSafe™ detects both immunoglobulin biomarkers together helping give an accurate diagnosis of the progress of infection, including previous infections which could indicate acquired immunity.
CoronaSafe™ Test Kit contains the following:
- 40 – COVID-19 Test Kit (Test, Dropper, Buffer Solution)
- 80 – Nitrile Disposable Gloves (40 pairs)
- 40 – Disposable Lancets (1 use)
- 80 – Professional Pre-injection Swabs (70% Alcohol)
How To Use
1. Use the lancet/click device to prick thumb/finger
2. Collect drop of blood in the capillary tube
3. Eject the blood drop into the sample well
4. Add 3 drops of buffer to the sample well
5. Wait 10 minutes and observe the results
Interpreting The Results
- IgG and IgM POSITIVE – Indicates that it may be a recent infection with COVID-19
- IgG POSITIVE – Indicates that it may be a previous infection with COVID-19
- IgM POSITIVE – Indicates that it may be a recent infection with COVID-19
- NEGATIVE – Indicates that it may be no infection with COVID-19, or there is not enough detectable antibodies in the early infection
Credentials & Quality Assurance
The test is certified by ISO and has been registered with MHRA for sale in the UK for professional use.
- ISO 18113-2 Requirements for information of in vitro diagnostic (IVD) reagents for professional use
- ISO 18113-4 Requirements for information of in vitro diagnostic (IVD) reagents for self-testing
- ISO 14971, ISO 18113-2, EN 17511, ISO 15193, ISO 15194, ISO 23640, EN 13641, EN 1041, ISO 15223-1
Clinical Study Results
1. The clinical sensitivity of the product was 98.81% (95% CI: 97.25%, 99.61%) and the specificity was 98.02% (95% CI: 97.05%, 98.74%) in 1,585 clinical samples (421 positive and 1,164 negative).
2. The homologous serum/plasma, whole blood samples (125 positive and 78 negative) of 203 subjects were compared. According to the results of serum/plasma test, the results of whole blood test were consistent: 96.85% (95% CI: 95.87%~97.60%).
“We’re implementing Coronasafe Covid-19 antibody tests from Martek Marine because they’ll help us identify infected persons to prevent an outbreak within our crew and on our vessels”
Neil Burns, Managing Director
James Fisher Shipping Services
This test provides only preliminary test results and should not be used for confirmatory testing or as a sole basis for diagnosis. The results will have to be interpreted together with clinical presentation. Any reactive specimen with the COVID-19 IgG/IgM must be confirmed with alternative testing method(s) and clinical findings.