Issue 14  April 15th 2016

Systemic errors at Canadian forensic laboratory Motherisk make national news and provide another example of consumer interest in accuracy of clinical laboratory testing

Hair tests developed by Motherisk Laboratory and used by the Hospital for Sick Children in more than 16,000 child protection cases throughout Canada (2005 – 2010) have been found to produce flawed results. The hospital, originally backed the validity and reliability of the testing, but has since conducted an independent review which found that they had been misled by the company repeatedly. An enzyme-linked immunosorbent assay test was used to determine if hair samples were positive, however the results were not confirmed against a second screening test method. At least one case has been overturned, in which a Toronto mother had been sent to jail for cocaine-related charges that were later thrown out due to the “validity of the [hair-strand] results”. The retired Ontario Appeal Court Justice Susan Lang, who had been provincially appointed to conduct an investigation, confirmed in her report that the, “…laboratory employed a preliminary screening test that specifically cautioned users about its limitations. Despite this caveat, the laboratory represented that this preliminary test could both identify and quantify drugs in hair. It could not. Also, the laboratory fell short of meeting international forensic analytical standards in other important ways that I describe in my report. Finally, the laboratory lacked expertise in the interpretation of the purported test results, which it frequently misinterpreted or over-interpreted.” The hospital has permanently stopped drug and alcohol hair testing by Motherisk for their cases.

FDA gives emergency approval to 3-in-1 test for Zika, chikungunya and dengue; Microcephaly caused by Zika confirmed

The Centers for Disease Control and Prevention (CDC) announced in a media statement that it will distribute testing kits that can determine infection with Zika, chikungunya or dengue within a single test call the Trioplex Real-time RT-PCR Assay. Facilities associated with the Laboratory Response Network which includes domestic and international lab that respond to public health emergencies will only receive the text at this time.

The CDC and other agencies have made assumptions that the Zika virus has caused microcephaly in newborns but have now released a publication on the findings that a causal relationship does exist. The evidence used to derive this includes: infection time in relation to prenatal development and defects observed, a review of a rare phenotype involving microcephaly and associated brain anomalies in fetuses and infants, and biologic plausibility data including the identification of Zika virus in infected brain tissue.

Theranos Takes a Shot at Redemption by Adding Experts to the Medical Board

Theranos is taking more steps to counter the scathing criticism it has received in recent months for inadequate leadership and inaccurate blood-testing technology. In early April, the company added high profile medical experts to its advisory board as well as opened proprietary data to scientific reviewers – a highly intelligent move if their data can withstand testing.

New members include:

• Susan Evans - former president of the National Academy of Clinical Biochemistry,

• William Foege, epidemiologist and former director of the U.S. Centers for Disease Control and Prevention,

• Ann Gronowski, a professor in the Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis.

A total of four medical doctors and six professors will contribute to a board who, now, all have scientific backgrounds. "This group together is really going to help not just Theranos, but all of the scientists out there who are involved, to understand the technology and utilize the technology and science," said David Helfet (co-chair) who is an orthopedic trauma surgeon at the Hospital for Special Surgery and New York-Presbyterian Hospital.

Related Article: Controversial health startup Theranos has barely any medical experts on its board of directors

Donors sue blood service after test failed to detect anemia

Donors to the Irish Blood Transfusion Service (IBTS) are grouping together for legal action against the organization as faulty testing equipment identified them as has having normal hemoglobin levels. Of the 1,700 individuals tested for the development of anemia after donation (2014 - 2015), medical follow-up was conducted and resulted in four donors requiring blood transfusions. A subsequent compensation claim will be made to the equipment manufacture for IBTS costs incurred of over €500,000 due to the situation. The impact of the faulty equipment can be identified in the 12% increase of deferrals based on accurate equipment results.