Sierra Leone Pilot Study of 10 Minute Ebola Rapid Test Shows Promise

SAN DIEGO, CA—(Marketwired – Dec 2, 2014) – Medical diagnostic manufacturer JAJ International, Inc. ( a subsidiary of LuSys Laboratories, Inc., receives promising results from a Sierra Leone Pilot Study for their Point of Care 10 Minute Ebola Rapid Test Diagnostic.

On November 18th, the WHO made an urgent call for a working solution to rapidly screen patients for Ebola. According to the WHO, standard RT–PCR molecular assays used in West African laboratories require a full tube of blood, laborious procedures, and cost around $100.

With no definitive therapy or vaccine to treat or prevent Ebola infection, a key strategy to controlling the spread of Ebola is rapid diagnosis to identify, contain and quarantine. Currently in West Africa, diagnosing Ebola infections can take several days, as time is lost transporting patient blood samples to distant laboratories. An accurate Ebola rapid test could change that, allowing medical staff to diagnose patients on the spot, in 10 minutes at a fraction of the cost of RT–PCR.

“We understand the difficult physical constraints facing medical professionals in remote clinics,” said James Lu, Vice President of JAJ International. “That's why our Ebola Rapid Tests are designed to accept just a single drop of blood, and provide results in 10 minutes, without the need for electricity or lab equipment.

Initial findings from last month's Pilot Study in Sierra Leone of our Ebola immunoassays were very encouraging. Since live Ebola samples are dangerous to work with, we rely directly on the data received from West Africa. One of our antibody formats was particularly promising with a Sensitivity of 82.4% and a Specificity of 80.0% in Sierra Leone. With an ultimate goal of 96+% Sensitivity and Specificity, our staff has already made significant improvements to increase accuracy of our Ebola tests. Both the improved Ebola antibody and new antigen prototypes are being shipping to Sierra Leone and Ghana for evaluation.

We are developing our Ebola Rapid Tests as a screening tool across several different mediums. Our 1st generation Ebola antibody and antigen tests will accept patient samples of blood drawn from a simple finger prick (also plasma or serum). We believe our unique 2nd generation Ebola Nasal swab and Saliva tests could be a game changer in providing non–invasive testing. They could be performed quickly by non–medical staff such as Airport Security, First Responders, and Border Patrol.”

JAJ has also joined forces with mobile health data analytics company BridgeCrest Medical to deliver cutting edge real–time medical data to health care professionals via mobile devices. For clients with the need to manage point of care event and information tracking across distributed sites and remote locations, this option provides actionable intelligence. Our vision is to quickly pull the test results and patient data into BridgeCrest's cloud–based HIPAA compliant platform and open the data through an API to all appropriate client organizations in an instant. BridgeCrest offers full support for JAJ's infectious disease and health monitoring diagnostic products. Together we can differentiate whether a patient with symptoms is suffering from Ebola or other diseases such as Malaria or Dengue in minutes.

Ebola rapid tests combined with PCR testing offers a cost effective balance in a system of confirmation, follow up testing and redundancy via inexpensive screening.

JAJ is determined to make the WHO's 'Ideal' Ebola assay, one that is rapid, sensitive, safe and simple to use. Operator safety is a primary focus in the design of our rapid tests. The death toll among medical staff in West Africa has been particularly heavy, as are the risks. Our top priority is to develop diagnostics that will keep health care professionals safe from exposure while quickly diagnosing patients to control the spread of Ebola.

Any requests for Evaluation of JAJ's Ebola diagnostic products are welcomed.

About JAJ International:
JAJ International is an American Manufacturer with over 170 different diagnostic products and 16 years of experience in R&D, rapid prototyping and manufacturing. A strong area of focus for JAJ has been Infectious Disease detection, with such rapid diagnostic tests as Malaria Pf/Pv specific, Dengue NS1/IgG/IgM, Nasal Swine Flu specific, Nasal Bird Flu, Tuberculosis, and Hepatitis (A, B, C, E).

Strategic Partner United BioDetection Technologies (UBDTech) is a master distribution channel for JAJ Ebola Rapid Tests to the US Military, US Government First Responder Agencies, and other foreign government agencies. UBDTech is a joint venture company with proven worldwide and US Government distribution networks. They are focused on virus detection and global bio–defense, supporting outbreak containment efforts through on–the–spot diagnostics.