By Gary Tufel
The US Food and Drug Administrations recent approval of Sysmex Americas pocH-100i has cleared the way for the complete blood count (CBC) and three-part differential hematology analyzer to be marketed to the clinical laboratory and the physicians office lab. Sysmex, based in Mundelein, Ill, is the US headquarters of Sysmex Corp of Kobe, Japan, a leading international manufacturer of medical diagnostic systems focused on hematology, hemostasis, immunochemistry, particle counting, urinalysis, and laboratory information systems.
The CBC results generated by the Sysmex pocH- 100i can be an important tool to aid the physician in patient care, says Peggy Barranco, MA, MT (ASCP) SH, product managerHematology, Sysmex America Inc. Used in innumerable diagnoses and treatments, including those for infection and leukemia, CBC is one of the 20 most ordered laboratory tests. Its closed-tube sampling capability provides greater safety for the instrument operator. Because of its small size and affordability physician office labs will no longer need to send samples to a larger laboratory. This will allow the physician immediacy of results, which improves care, Barranco adds.
The Sysmex pocH-100i reports a CBC with a three-part differential. It has the smallest footprint (13.8 inches high x 7.3 inches wide x 18.1 inches deep) and the smallest sample requirement (approximately 15 µL aspirated in whole blood mode and 20 µL required in prediluted mode) of any Sysmex hematology analyzer. These small sample sizes are a true benefit for lab personnel attempting to draw a blood sample from a child or from an oncology patient.
The Sysmex pocH-100i utilizes the impedance counting method where blood cells suspended in the diluted sample pass through an aperture, causing direct current resistance to change between the electrodes. As the direct current resistance changes, the blood cell volume is detected as electrical pulses. The analyzer offers reliability and quality results and is ideally suited for low-volume testingas few as five CBC tests per day, Barranco says.
Charles Dahlgren, lab manager for Saint Johns Regional Health Center in Springfield, Mo.
The pocH-100i provides results comparable to Sysmexs high-end systems, which is particularly beneficial when the analyzer is used in an integrated health network (IHN). The systems technology is common to other Sysmex systems, and the red cells and platelets are measured using the same hydrodynamic sheath flow technology as Sysmexs high-end systems that aid in diagnosis and monitor patient therapy. As with all Sysmex analyzers, the system utilizes only nonhazardous reagent systems. In addition, the physician, whether in the office or at the hospital, has immediate access to important patient diagnostic information.
Charles Dahlgren, lab manager for Saint Johns Regional Health Center in Springfield, Mo, was an evaluator for the FDA study and ran an 8-month test on the pocH-100i. He says it worked like a dream. Ive worked with other analyzers and found them to be large, cumbersome, and complicated to use. But I was impressed with the pocH-100i and impressed by the results, he says.
Many manufacturers have tried to downsize their large blood analyzers to fit in clinics, but this was designed for clinics, Dahlgren says. The Sysmex blood-cell counter delivers 17 parameters of results and requires only 15 µL of whole blood. Its small size makes it ideal for use in doctors offices, large hospital laboratories, or smaller off-site labs and blood banks.
Dahlgren says testing is easy with the pocH-100i. All that is required is collection of the blood sample in a vial or tube, inserting it in the analyzer, closing the door, and pushing a button. The analyzer pierces the containers cap, draws the blood sample through the cap, and takes out 15 µL for analysis. Minutes later, the analysis is complete.
The tiny quantity of blood required makes this analyzer ideal for testing the blood of babies or difficult patients. A quick pinch of a finger or heel provides enough blood to sample, Dahlgren says. Although this Sysmex analyzer is intended mainly for use in physicians office labs, it is still useful as a backup analyzer for five-part differential systems at large hospital labs like Saint Johns, which performs about 15,000 CBCs a month. We have five other smaller hospitals and physicians clinics where this analyzer is very useful. What they cant perform on-site, they send to us to do, because were an IHN.
Besides ease of use, quick results and small size, the pocH-100i offers another important benefitlow cost. Our top-end analyzer is automatic and costs about $500,000. The pocH-100i is very simple and costs only $10,000 to $12,000, and its results are comparable with those of the large analyzer, Dahlgren says.
This is important because the doctor admitting a patient can put CBC results from the pocH-100i into the same computer as the hospital does, both before and after treatment. There may have been different methods used to perform tests, but the results will be consistent, says Dahlgren. Often theres a bias from one type of analyzer to another, but results compared to the hospitals Sysmex XE 2100 showed a high correlation. All results checked even though different analyzers were used, he says.
Weve always tried to standardize, and with the pocH-100i weve achieved consistent results. Standardization had been achieved among large and mid-sized medical facilities, but this product extends standardization to all labs, satellite labs, and clinics, and we know that the results will check out, says Dahlgren.
Another benefit of the pocH-100i is its ease of use. The touch-screen menu is easy to follow, and the operations are easy, as are maintenance and quality control.
The analyzer starts up by itself. QC is performed and within a few minutes you are ready for patient analysis. The instrument is very intuitive, with help screens that direct the operator to the next action steps. And its easy to deal with when you do have problems. The user clicks on the touch screen and the unit provides helpful hints, Dahlgren says.
Its a well-thought-out product, he continues. We were very pleased with it during the test. Now that the product has been FDA-approved, its on the market and there are already some clinics interested, as is the main Saint Johns facility.
| Seventeen parameter CBC with three-part differential, including a true neutrophil count|| Complete hematology results essential for patient and physician satisfaction|
| Small footprintthe main unit is 13.8 inches high x 7.3 inches wide x 18.1 inches deep, and weighs 30.8 lb|| Fits in any size clinical lab setting|
| Closed-tube sampling|| Safety for laboratory personnel|
| Two nontoxic reagents in prepackaged volumes|| Provides safety for staff and convenience in ordering and storage|
| Proven DC detection with added benefit of hydrodynamic focusing|| Accurate, reliable results for any clinical settingPOL, clinic, or hospital|
| Push-button operationintuitive LCD screen menu|| Minimal operator training requirements|
| Simple maintenance|| Saves time|
| Interface capableSerial RS-232 or LAN (TCP/IP)|| Ability to link to IHN computer system for optimum data management|
| Low cost per test|| Key to managing costs with current reimbursement|
Gary Tufel is a contributing writer for Clinical Lab Products.