XW-100 from Andrew J. Schuman on Vimeo.

The CLIA’ 88 regulations, were published in 1992 and phased in through 1994.  Over the years they’ve had a dramatic impact on primary care medical practice.  Before their implementation primary care physicians could perform urine and throat cultures in their office, spin hematocrits, and perform a modified CBC using a neat device called the QBC Star.  CLIA’ 88 took all this away as most small practices could not afford to maintain a “moderately” complex lab.  Eventually, devices began to emerge that gained FDA approved CLIA ’88 waived status.  The first in my memory was the Hemacue for determining Hemoglobin levels, and then rapid diagnostic tests for strep A detection followed shortly thereafter.

We’ve had no  point of care, waived CBC device in the US until this year!  Sysmex corporation based in Japan and world leader in hematology analyzers modified their highly successful PocH-100i tabletop analyzer and introduced the Clia’88 waived XW-100 hematology analyzer several months ago. 

Having a CBC test in office can help physicians make important decisions regarding the need for antibiotics or further testing.  In the setting of treating febrile patients, especially children, a normal or a CBC which a predominance of lymphocytes can be reassuring,.  In contrast, an elevated CBC may suggest that more attention need to be taken when a source of infection is not evident.

As shown in the video the XW-100 is easy to setup and use. Effectively it is fully automated, and users simply follow on screen instructions.  The machine attaches to reagents and an exhaust reservoir.  The device requires 3 controls be run every 8 hours, a process which takes about 20 to 30 minutes.   Venous specimens take just 3 minutes to run, and results are printed on a thermal printout with normal values for age accompanying the results.

 

It is slightly noisy during operation, but it is nice to be able to run CBCs in the office rather than send patients to the local hospital for testing, and then calling with results after they have left the office.

The FDA has approved the XW-100 device for “non-critically” ill patients 2 years and above and can only be run on venous (not finger stick) samples.   The FDA also limits the XW-100 device in that results are suppressed if the platelet count is below 100,000 , the hemoglobin is below 10, or when the white blood count is below 3000, requiring a physician to obtain a specimen at a hospital lab.  Hopefully as more waived CBC devices become available, the FDA will relax their restrictions.

 

 

Clarius Scanner from Andrew J. Schuman on Vimeo.

I’ve always been interested in new medical technologies. Over the years some have proven themselves indispensable and have changed medical practice.  A few come to mind quickly – such as he temporal thermometer – which speeds taking of vital signs, the pulse oximeter – which helps us determine if a patient has a significant respiratory illness, and OAE hearing screeners and photo screeners which improve our ability to diagnose children with hearing and vision problems.  I would add to this list the  new Clia ’88 waived devices have provided the means to incorporate PCR diagnostics in the office during the visit.

I’ve long been intrigued by portable ultrasound devices.  Clarius Mobile systems has sold thousands of these to medical specialists who routinely use diagnostic ultrasounds in their practice.  But what about primary care specialists???

As shown and discussed in the video the Clarius Wireless Portable Ultrasound is affordable, and connects wirelessly to a user-friendly application on an android or IOS smartphone or tablet.  Images or ultrasound recordings are then uploaded to the “Clarius Cloud”, for later review by providers.    The application simplifies the process of performing an ultrasound by integrating presets, so few adjustments are needed.

The review article “Lung ultrasound for the diagnosis of community acquired pneumonia in children” ¹ looked at several studies where ultrasounds were compared to x-rays and CT studies to diagnosis pneumonia in children. The authors concluded that ultrasound could diagnosis pneumonia in pediatric patients with the same accuracy, less radiation exposure, quicker, and at lower cost compared to the other modalities.

How much training and support would a physician need to become facile with a portable ultrasound device?  It would be wonderful if primary care physicians could have a new diagnostic tool! In the primary care setting ultrasound could be used for bladder scans, lung scans, abdominal scans, and joint scans .  It could be used to determine whether suspected abscesses are drainable, and guide joint injections, lumbar punctures etc.

Stay Tuned! I will update Medgizmos viewers as I learn more about this exciting technology!.

 

1. Stadler JA,  Savvas A,  Heather J. Zar, HJ: Lung ultrasound for the diagnosis of community-acquired pneumonia in children Pediatr Radiol (2017) 47:1412–1419