As with so many other diagnostic procedures that had previously been performed by clinical laboratories, kits and devices to determine LDL, HDL, total cholesterol and triglyceride levels now offer inexpensive, accurate, reimbursable, easily used and rapidly performed testing methods. Some of these products are CLIA-waived, making their use a practical enhancement of care for point-of-care settings like physician offices and clinics.
The CLIA-waived serum sample analyzers are highly flexible, incorporating glucose testing with various lipid panels and, in one device, liver function assessment as well.
Cholestech Corporation, Hayward, Calif., produces the Cholestech LDX System that uses patented, technology to measure a range of lab values from a fingerstick blood sample. Result processing takes about five minutes, according to the company.
Depending on the test cassette selected, testing can be performed for the following combinations: Total Cholesterol; Total Cholesterol and Glucose; Total Cholesterol and HDL; Total Cholesterol, HDL, and Glucose; A Lipid Panel consisting of Total Cholesterol, HDL, Triglycerides, TC/HDL ratio, estimate of LDL and VLDL, and an all-inclusive panel consisting of Total Cholesterol, HDL, Triglycerides, Glucose, TC/HDL ratio, estimate of LDL and VLDL.
Immediate liver function results are also available with the devices newly available ALT (Alanine Ami notransferase) testing capability. The tabletop analyzer unit measures 8 x 4. The device is factory calibrated, and easily accommodates software upgrades. Along with the analyzer and a starter pack of cassettes, the system includes a power supply, small printer, optics check cassette, user and procedures manual and a training video.
Polymer Technology Systems, Inc., Indianapolis, Ind., produces a 4.3 oz., battery-operated, handheld device called the Professional CardioChek P.A. This device is one of several manufactured by the company that use proprietary test strips and a reflectance photometry processor to perform a wide range of in-office tests on a single fingerstick whole blood sample. As with the Cholestech analyzer, the CardioChek product can perform a variety of tests, depending on the test strip selected. Options include a lipid panel and single testing for glucose, ketone, total cholesterol (100-400 mg/dl), HDL cholesterol (25-85 mg/dl), triglycerides (50-500 mg/dl) and calculated LDL cholesterol, all as CLIA-waived tests. The device can also measure creatinine, however, this assay is not a CLIA-waived test.
The company says that the Professional CardioChekPA meets the monitoring requirements of the National Cholesterol Education Program (NCEP) and most tests are eligible for Medicare and other insurance reimbursement.
The device features internal result storage for easy review. The accompanying thermal printer can print test results with time and date information on the spot or using data stored in the analyzers memory. The printer is capable of printing on 500-count thermal labels or thermal paper rolls.
Roche Diagnostics, Basle, Switzerland, manufactures the Accu-Chek InstantPlus Meter to perform total cholesterol (150-300 mg/dL) and glucose (20-600 mg/dL) with the same system. This simple, CLIA-waived test provides total cholesterol results in three minutes and glucose results in just 12 seconds.
As with th e other devices in this category, a fingerstick blood sample is mounted on a test strip and inserted in the analyzer. In this case, a separate strip is required for either glucose or total cholesterol testing. Three AAA batteries supply enough power for over 1000 tests. Test strips have a long shelf life and require no refrigeration.
In addition to the three devices described above, several cholesterol analyzers have been cleared for home use, and there is a range of test strips that do not require analyzer devices to test for total cholesterol.
Given the convenience and flexibility, clinical importance and interest to patients of this category of testing, it appears that point-of-care assessment of blood lipid values will continue to expand as a routine patient care activity. At the same time, the widespread competition in this field will likely yield even faster, more accurate and more comprehensive devices at even lower costs.
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