GENEME UK

Science

[ F R A N K D ]
The fastest Nucleic Acid Amplification Test (NAAT) available

Science summary

FRANKD is an RT-LAMP NAAT as recommended by the WHO to detect SARS-CoV-2

Patented enzyme used for direct virus detection

Targets 1 gene with 6 primers

100% specific and 97% sensitive to SARS-CoV-2

Does not require RNA purification, hence no need to use RNA isolation equipment

Processing time of 30 minutes (excludes time for swabbing)

Designed to reduce the chance of cross contamination

The Science Behind FRANKD

FRANKD is a reverse transcription loop-mediated isothermal amplification (RT-LAMP) test. FRANKD tests for the presence of SARS-CoV-2 RNA directly from the sample. A nasal or throat swab is used to sample viral material from a testee in the same way as standard RT-PCR testing. 

FRANKD is a NAAT

The World Health Organisation recommends NAAT tests to detect SARS-CoV-2. 

In the WHO Interim Guidance on Laboratory testing for coronavirus disease (COVID-19) in suspected human cases (https://www.who.int/publications/i/item/10665-331501), it states that “Suspected cases should be screened for the virus with nucleic acid amplification tests (NAAT), such as RT-PCR.”

According to the WHO, the types of nucleic acid amplification tests (NAAT) are: Polymerase chain reaction (PCR) – including nested (n), quantitative (q) or real-time reverse transcription (RT) PCR), loop-mediated isothermal amplification (LAMP), and quantitative nucleic acid sequence-based amplification (QT-NASBA). This is illustrated in the diagram below.

FRANKD is a NAAT, specifically, it is a Loop-Mediated Isothermal Amplification (LAMP) test, which are sometimes called Isothermal tests. LAMP is a more modern technology than RT-PCR which has been used for several decades. Although LAMP is a newer technology, it is technically simpler and easier for technicians to perform, making it an ideal technology for a point-of-care test (POCT).

Patented Enzyme

FRANKD utilises a special patented polymerase enzyme for virus detection. 

The enzyme is combined with protein (NeqSSB – which binds to single stranded DNA and RNA). This unique approach has been proven to increase the processivity of the enzyme and specificity of the test. Hence the test is both fast and very specific (100% specificity in independent laboratory tests).

In addition the FRANKD patented enzyme is resistant to inhibitors which can be present in surgical swabs, hence the risk of false-negatives in non-lab real-world environments is reduced. Positive results are provided by the detection of fluorescence of intercalating dyes that emit light when bound to DNA, as a result of the amplification process.

Details of Patent

Dawid Nidzworski, Kasjan Szemiako, Marta Śpibida, Patent no P.426093 from 27.06.2018. Patent by IBMM licensed to GeneMe Sp. z o.o.

Sensitivity and Specificity

An independent clinical trial of FRANKD has shown Sensitivity of 97% and Specificity 100%.

What is Sensitivity? – This is the ability of a diagnostic test to give a positive result when the person being tested has the disease, and is supposed to be tested as positive (i.e. the true positive rate)

 

What is Specificity? – This is the ability of a diagnostic test to indicate a negative result when the person being tested does not have the disease, and is supposed to be negative (i.e. the true negative rate).

The benchmark used for the test was an RT-PCR test. This means FRANKD has a Sensitivity of 97% and a Specificity of 100%, when compared to an RT-PCR test, which is currently the most commonly used.