Last year the Medicines and Healthcare products Regulatory Agency (MHRA) published a Target Product Profile (TPP) for COVID-19 diagnostics. A TPP outlines the desired ‘profile’ or characteristics of a product that is aimed at a particular disease or diseases.

TPPs state the intended use, target populations and other desired attributes of products, including safety and performance-related characteristics and sets the standard by which tests are judged. They tell device developers and key stakeholders both the ‘desirable’ characteristics a test must have to be successful for the intended use and also what they judge to be minimally acceptable.

Independent clinical trials have confirmed that the MFX Biotech test cassette, running on the modified AFS-1000, comfortably exceeds the ‘desirable’ or highest MHRA performance characteristics set for COVID-19 point of care tests. 

0%
Sensitivity

95% CI 94.35% to 99.38%

0%
Specificity

95% CI 97.27% to 99.91%

0TCID50/ml
Limit of Detection

Less than 100 copies/ml

MHRA Performance TPP

CHARACTERISTIC MHRA SPEC MFX PERFORMANCE
Clinical (diagnostic) Sensitivity (or Positive Percent Agreement) Greater than 97% (within 95% confidence intervals of 93- 100%)
Verified in at least 150 positive clinical samples covering a meaningful range of viral loads.
97.75%
95% CI 94.35% to 99.38%
Tested on 176 positive clinical samples, Ct 13 – >40
Clinical (diagnostic) Specificity (or Negative Percent Agreement) Greater than 99% (within confidence intervals of 97- 100%) 99.24%
95% CI 97.27% to 99.91%
Tested on 262 negative clinical samples
Analytical Sensitivity (Limit of Detection) Fewer than 100 SARS- CoV-2 copies/ml 0.5TCID50/ml
100 copies per ml is equivalent to ≤1.0TCID50/ml in non-PCR assays
Analytical Specificity Tested against other relevant pathogens and other substances for interference Tested and does not cross-react with other human coronaviruses*
*Tested and does not cross-react with Local human coronavirus (hku1, nl63, oc43), H1N1 (new type A H1N1 influenza virus (2009), seasonal H1N1 influenza virus), H3N2, H5N1, H7N9, influenza B, Yamagata, Victoria, respiratory syncytial virus, rhinovirus A, B, C, adenovirus 1, 2, 3, 4, 5, 7, 55, enterovirus A, B, C, D, EB virus, measles virus, human cytomegalovirus, rotavirus Virus, norovirus, mumps virus, varicella zoster virus, Mycoplasma pneumoniae. No significant effect on the test results with haemoglobin ≤5g/l, bilirubin ≤342.0μ mol/l, triglyceride ≤11.3mmol/l, rheumatoid factor ≤80IU/ml.
Turnaround Time Less than 30 minutes from sample to result 15 minutes
Throughput More than 100 tests per unit per 12 hours Over 3,000 tests per unit per 12 hours

We believe the modified AFS-1000 running our exclusive Sichuan Xincheng Bio cassette is the only machine on the market that exceeds all the higher performance characteristics set by the MHRA foor COVID-19 POC diagnostic tests. 

With the capacity to process 250 – 300 tests per hour with each test taking 15 minutes for the reaction to take place then seconds to process in the AFS-1000 it is now possible to screen hundreds on their way in to a venue or workplace. Also because the test is for viral antigens it is not affected by RNA-positive test subjects who are no longer infectious but will still test positive on nucleic acid amplification assays such as PCR or LAMP. 

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