NG Biotech, Guipry, France, and Atomo Diagnostics, Sydney, Australia, have developed a fully integrated blood-based rapid test for the detection of human chorionic gonadotropin (hCG) levels in pregnancy.

Delivering accurate results in 5 minutes, the NG-Test blood precision hCG test uses a lateral-flow platform that incorporates an integrated buffer delivery mechanism.

Testing of hCG levels is routinely performed in emergency departments when a female patient is admitted with abdominal pain or bleeding. Approximately 20 million hCG tests are performed annually in the United States and Europe and, in such cases, either laboratory-based blood analysis is carried out, giving a result in 1 to 2 hours, or a urine rapid test is performed, with results available in 20 to 40 minutes.

Urine rapid tests have previously been seen as quick and easy but have proven to be problematic in busy primary care environments. Sample collection can be challenging and time-consuming, and urine is a less sensitive sample medium than blood. Insufficient or diluted urine samples can also affect test accuracy and cause false-negative results. In addition, because of the time required to obtain results, laboratory-based blood tests for hCG are not well-suited for use in critical point-of-care settings.

The new rapid hCG blood test from NG Biotech and Atomo has been designed specifically to simplify the test procedure and reduce the number of user steps by integrating all necessary components into one intuitive, single-use device. The test aims to mitigate problems commonly associated with standard rapid diagnostic test kits, particularly those relating to insufficient blood sample, difficulty with blood collection or transfer to the platform, improper use of buffer, or inadequate buffer volume delivery. It requires a small blood sample of 10 µL collected from a fingertip.

The device platform designed and developed by Atomo incorporates a built-in safety lancet, a unique blood collection and delivery system, and an integrated buffer delivery feature, which collectively help to prevent user-related errors and improve test performance. Improved usability means this new test could potentially be performed by untrained health technicians and diagnostic decisions can be made more promptly, saving time and reducing costs.

“We are proud to have partnered with Atomo Diagnostics to develop our next-generation hCG blood test,” says Milovan Stankov Puges, CEO of NG Biotech. “We hope and believe that this will be but the first of many collaborative projects that draw on the assay development expertise of NG Biotech and the device design capabilities of Atomo.”

NG Biotech and Atomo Diagnostics are also partnering to develop new test applications for over-the-counter and point-of-care markets worldwide.

“Our all-in-one AtomoRapid diagnostic test devices are designed to overcome the user issues and reduced levels of sensitivity common with in-field deployment of multicomponent test kits,” says John Kelly, CEO of Atomo Diagnostics. “The team at NG shares our passion for innovation and we look forward to extending the scope of our partnership in the future.”

The NG-Test blood precision hCG test is expected to be available for use throughout Europe in 2017, and regulatory approval will thereafter be sought for commercialization in the United States. Additionally, NG Biotech intends to seek regulatory approval for an over-the-counter version for lay users.