News Trends Analysis

Dec. 1, 2011


Investing in African lab medicine. SoftTech Health, a New York-based company, is donating $1,000,000 to the African Society of Laboratory Medicine to help healthcare labs in Africa strengthen their quality systems, while bypassing technical obstacles that have traditionally precluded such projects. This donation, by Craig Madison, Senior Partner of SoftTech Health, is the first $1 million of a pilot project that will provide labs in 47 African countries with no-cost software licensing, servers, connectivity, systems maintenance, ongoing training, and support.

A key to the success of this project is SoftTech Health's plan to address a critical obstacle: Africa does not have the capability to host a solution of this scale due to the lack of a technical infrastructure. Existing Information Technology capability is sporadic, there are not enough trained personnel, and there are not enough funds available to remedy the situation by developing the technical systems piece by piece. The SoftTech Health Project will enable healthcare labs across Africa to effectively leap-frog over years' worth of traditional infrastructure evolution. In conjunction with the CDC, the first stage of the project is providing the labs in Africa with Quality Management systems which are internationally recognized by authorities such as the CAP and ISO. Later stages will encompass software for Occurrence Management, Feedback Management, Proficiency Management, and Accreditation Management.

Infectious Diseases

Roche receives FDA approval for acute hepatitis B test. It was no Halloween trick when, on Oct. 31, the FDA granted Premarket Approval (PMA) to Roche for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay, for use on the cobas e 601 analyzer. The test represents the final component of the acute panel within the hepatitis test menu for the cobas 6000 series.

The Anti-HBc IgM assay is used for the invitroqualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of an acute or recent hepatitis B virus (HBV) infection. The assay is intended for use with Roche's electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges.

Direct test for influenza and respiratory viruses in Europe. Quest Diagnostics announced that its Simplexa Flu A/B & RSV Direct test will be available in Europe. The new test, from the company's Focus Diagnostics business, uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting. Nucleic-acid extraction requires specialized molecular equipment and trained personnel. It involves extracting DNA or RNA from a blood, plasma or other specimen type for testing. The nucleic-acid extraction process, used in most commercial molecular test kits, can add approximately 60 to 90 minutes to total testing time. Focus Diagnostics has replaced the process with a proprietary reaction-mix technique.

Quality Control

CLSI publishes new guideline based on risk assessment. The Clinical and Laboratory Standards Institute (CLSI) recently published Laboratory Quality Control Based on Risk Management: Approved Guideline (EP23-A). This document provides guidance based on risk management for laboratories to develop quality control (QC) plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test. Those using this guideline will receive an overview of the QC tools available to the laboratory and discover their advantages and limitations. Through this instruction, laboratorians will learn to determine QC procedures that are both appropriate and effective for the test being performed. As a result, this guideline will help laboratory professionals develop a QC plan that can improve efficiency in the laboratory by preventing errors, detecting weaknesses, and minimizing risk.

New Studies

HPV may be linked to cardiovascular disease. A new study by researchers at the University of Texas Medical Branch suggests that the human papillomavirus, which has been linked to cancer of the cervix and other cancers, may also play a role in heart disease and stroke. According to the The Journal of the American College of Cardiology, women infected with HPV are two to three times more likely to suffer a heart or brain attack than women who are not infected with the virus. It is known that HPV damages the p53 gene, which serves to protect the body from cancer; researchers theorize that damage to p53 might also lead to thickening or inflammation of arterial walls, thereby increasing the risk of stroke and heart attack in patients who do not have any of the other risk factors that are typically associated with cardiac or neurological events.

Toxic substance rapid test. The search for a rapid, non-invasive way to determine whether people have been exposed to potentially toxic substances in their workplaces, homes and elsewhere has led scientists to a technology that literally takes a person's breath away. Their report identifying exhaled breath as an ideal indicator of such exposure appears in the American Chemical Society's Environmental Science & Technology. Study authors Andrea M. Dietrich and Masoud Agah and two of their students explain that scientists have known since the late 1970s that exhaled breath contains traces of any potentially toxic substances that people may have inhaled.

Research has shown that those amounts accurately reflect the levels that exist in a person's blood. Sampling breath is less invasive than drawing blood, more convenient than taking urine samples, and may be less costly and have a faster turnaround time than either. Microelectronics have helped position breath analysis for more extensive use in the 21st Century, as equipment for analyzing substances in human breath have been reduced to hand-held size. The technology can quickly detect minute amounts of substances, offering the promise of helping limit human exposure.


New test may defuse the PSA test controversy. Ever since the U.S. Preventive Services Task Force recommended in October that healthy men should not have PSA antigen screenings for prostate cancer—because the screenings lead too often to false positives and subsequent unnecessary or even harmful treatment—there has been considerable controversy over the wisdom of the recommendation. Now San Diego-based Gen-Probe has announced that it has developed an experimental prostate cancer screening test that it says is more accurate. Gen-Probe claims its Progensa test, which screens urine samples for prostate cancer antigen 3, can better differentiate between malignancies and other conditions that create the false positives in the traditional PSA blood test. The Progensa test, which is currently under FDA review, would not replace the PSA test, but be used along with it. Men who test positive for PSA antigen would then take the urine test as a further
diagnostic check.