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13th July 2022

Monkeypox: the need for rapid diagnostics development, effective surveillance and intervention

As of July 8, about 800 and 570 cases of monkeypox have been reported in the United States and the United Kingdom, respectively. This may not reflect the full extent of the outbreak because getting tested is considerably difficult. Although most cases so far have been among gay and bisexual men, monkeypox can be transmitted through close personal contact within any group irrespective of their sexuality.

Monkeypox primarily occurs and is endemic to some countries in Africa. It is related to smallpox but less deadly, transmitted via skin-to-skin contact, and it causes flu-like symptoms and a rash anywhere on the body. In the current outbreak, many men have had lesions on the genitals or in the anal area, indicating it’s easily transmitted during sex. Unlike COVID, monkeypox spreads slowly; the current outbreak has caused no deaths in countries where monkeypox is not endemic. However, if the virus spreads too widely, like COVID, it could be here to stay.

One of the challenges to fighting monkeypox is the difficulty in getting tested. The testing has been cumbersome and time-consuming, frustrating both the individuals who have symptoms and the clinicians

The widely known and used testing involves the clinicians contacting the local or state health department for authorization to run a test on a suspected case, after which a lesion on the skin is swabbed. The first round of testing for orthopox is done at the Laboratory Response Network; if positive, the sample is then forwarded to the Centers for Disease Control and Prevention (CDC) for a definitive diagnosis.

Although in the bid to increase testing access and convenience the CDC has established some form of decentralization and begun shipping orthopox tests to five large commercial labs, the current PCR tests can only be done on people who have lesions to swab. What about those who are yet to develop symptoms?

Using body fluids like saliva or throat swab tests could enable easier diagnosis, and there is a potential of making a diagnosis in those who have been exposed but not yet developed symptoms.

Also, taking tests to the laboratory and getting the results can be time-consuming. Having a rapid diagnostic tool with a digital reader application that can be used next to the patient, and even away from the hospital through community screening, could help inform clinicians much easier and quicker about the spread of the disease.

The partnership Between SureScreen Diagnostics, TestCard, and Guy’s and St Thomas’ NHS Foundation Trust

The partnership between the three organizations aims to incorporate the monkeypox lateral flow device into TestCard’s ClearScreen app, thereby enabling the results to be transferred rapidly directly onto the patient’s medical record, making it easier to track the spread of the disease and notify health bodies. This antibody test, run by using a small drop of finger-prick blood, can detect monkeypox infections in humans in just 10 minutes.

SureScreen Diagnostics, a UK life science firm with a 25-year history of expertise in lateral flow testing, developed this latest test in record time to react quickly to the need of clinicians. These tests could be ready for deployment within a couple of months if clinical trials at Guy’s and St Thomas’ are successful.

The three organizations had previously worked together on developing lateral flow tests and digital reading applications for COVID-19.

The COVID-19 antigen LFTs developed by SureScreen were the first European tests to pass the validation process in the laboratory by Public Health England last year. They are currently being used as part of the UK Government’s rapid testing programme, as well as being exported to about 60 countries worldwide.

Although monkeypox does not spread easily and there is currently no need for mass community testing, emerging infectious diseases require rapid diagnostics development, efficacious surveillance and health information systems capable of using point of care diagnostic data for rapid and productive interventions.

This new lateral flow test will help clinicians with rapid identification of cases, clusters, and the sources of infection earlier than previously possible. This will assist clinicians in providing optimal clinical care to patients and prevent further transmission.

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