Glycohemoglobin analyzers.

Abstract

For the millions of people with diabetes, maintaining near-normal glucose levels is vital for reducing or slowing the complications of the disease. A crucial tool for monitoring blood glucose levels is the glycohemoglobin (GHb) test. GHb analysis indicates the amount of glucose a patient's red blood cells were exposed to during the previous two to three months, allowing physicians to track trends and make appropriate changes in therapy. In the United States, this test is commonly performed on blood samples that have been sent to a laboratory, with written results provided to the physician several days later. Recently, though, analyzers have come onto the market that can be used at the point of care--a clinic or physician's office--or even in the home, providing results immediately. We evaluated five GHb analyzers from four suppliers: Axis-Shield, Bayer, Bio-Rad Laboratories, and Metrika. These products vary considerably--for example, one is a single-use test kit intended for point-of-care settings, while another is a batch analyzer that can run 15 samples at a time and is designed for low- to moderate-volume laboratory use. Our testing focused primarily on the analyzers' accuracy, precision, and ease of use. Different facilities will have different requirements, and none of these factors alone should determine a facility's purchasing decision. Rather, purchasers will have to balance all the performance factors--along with cost--when choosing a product. Consequently, we have provided separate ratings for hospital laboratory testing, point-of-care testing, and--for the one applicable unit--home testing.