News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Clinical Laboratory Scientists Help Crack Newborn Marijuana Mystery

Surprising source of positive medical lab test results was discovered by a special team including pathologists, medical technologists, nurses, and physicians

Some innovative sleuthing by clinical laboratory professionals at University of North Carolina School of Medicine (UNCSM) hospitals has helped solve a marijuana mystery involving neonatal screenings. An unexpected spike in “false positive” cannabis exposure screening results in newborns at the facilities triggered a study by UNCSM scientists.

Revised Screening Protocol Leads to Jump in False Positives

According to a story in MedCity News , in July 2011, the UNCSM clinical laboratories received a call from nurses in the neonatal nursery. They had noticed an increase in positive results in screenings for tetrahydrocannabinol-delta 9-carboxylic acid (THC). THC is the principal psychoactive component of the cannabis plant. (more…)

Immunoassay and Infectious Disease Analyzers Evaluated during Use by Clinical Pathology Laboratories

Industrial engineering firm issues “Consumer Report”-type assessment of mid-volume, automated IA and ID analyzer systems

It’s not often that pathologists and clinical laboratory managers can access a Consumer Reports-type of comparison of laboratory analyzers as they prepare to purchase new diagnostic systems. In the case of mid-volume analyzers for immunoassy (IA) and infectious disease (ID) testing, such a report is now available—and it is immediately available on the Web.

The report is titled “Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing.”  This report can be immediately downloaded and viewed by visiting the web site.


A Tale of Two Analyzers and Other Thoughts from AACC 2008

There were plenty of new and interesting analyzers, lab tests, and other products on display this week in Washington, DC, at the exhibition during the annual meeting of the American Association of Clinical Chemistry (AACC). Dark Daily was there to take it all in and to identify emerging trends in laboratory and pathology management.

There were new instrument systems galore, because many in vitro diagnostics (IVD) manufacturers use the AACC exhibition as the place to unveil their latest generation of products. Two examples of new analyzers illustrate how technology advances are contributing to useful new capabilities.

For use in the core laboratory, Ortho-Clinical Diagnostics (OCD), a Johnson & Johnson Company (NSYE:JNJ), showed off its new VITROS 5600 Integrated System, which puts chemistry and immunoassay into a single, integrated platform. What caught Dark Daily’s attention is how this instrument incorporated Lean principles in its design and operation. For example, OCD calls it a “one-tube-in, one-tube-out” workflow guided by onboard intelligence to prioritize the next 50 tubes in the queue and handle them independently and in parallel for both chemistry and immunoassay. It has an onboard menu that will support 120 assays. Another intriguing aspect of this new instrument system is that, because it uses dry chemistry, there is no need for water or waste lines. That feature will give this instrument system an interesting appeal for laboratories that want flexibility in placing the instrument while eliminating the need for expensive remodeling to supply a water and waste line to the instrument. This instrument will be available for purchase by early 2009.

A second analyzer is designed to allow community hospitals to expand their molecular testing capabilities. HandyLab, Inc. of Ann Arbor, Michigan, was showing its Jaguar platform. This is an open system for molecular assays that will produce molecular results in 45 to 90 minutes. The random access Jaguar will perform specimen preparation, amplification, and real-time PCR automatically, using room temperature reagents. It can perform 1 to 24 samples at one time and will test up to 200 samples per nine-hour shift. The Jaguar has a competitive price and is designed to support laboratory developed tests (LDPs).

With more than 800 vendors exhibiting at the AACC event and only three days of exhibition hours, it is difficult for any single individual to get by all the booths and evaluate the innovations and new products being shown. One important trend that could be seen in walking around the exhibition is the number of new vendors showing proprietary assays and lab tests. A ballpark guess is that more than 50 firms with new lab tests were exhibiting at AACC for the first time. Also, the number of exhibitors in the international area has increased over the past year.

Finally, a personal comment. Your Dark Daily editor decided to allow himself to be tested at one of the companies offering a free test of their proprietary assay. I thought this would be an easy process, since I give blood regularly and phlebotomists always tell me I have good veins. In conversing with the phlebotomist as the draw was performed, I learned that this individual was a seven-year employee with one of the national laboratories. I also observed that, after inserting the needle in my arm, this phlebotomist was fooling around for more than 30 seconds attempting to get blood to flow from that site. I quietly encouraged her to withdraw the needle and try the other arm. That second venipuncture went successfully. By the way, as a former rugby player with more than two decades of playing experience and my share of stitches, the first attempt at venipuncture was not painful or agonizing. So Dark Daily readers can be assured that your editor was NOT traumatized, only the nearby observers were.

My comment on this experience is that it demonstrates the difficulties laboratories face in providing tip-top service to consumers. Additionally, the folks with me had a chuckle discussing about how the senior executives at that phlebotomist’s home company might react were they to learn that it was the Editor of Dark Daily and The Dark Report who experienced a less-than perfect venipuncture at the hands of their phlebotomist! It is also a reminder of the variability in care delivered to patients and why reducing such variability can give laboratories competitive advantage.

Regards and enjoy the remaining weeks of summer!

Robert Michel

Editor, Dark Daily