Not all consequences of the FDA's concern for user safety relate to the specific product u n d e r e v a l u a t i o n . A c c o r d i n g to A m m i r a t i , t h e FDA needed 17 m o n t h s to clear the chol e s t e r o l t e s t for h o m e u s e , e v e n though the product had already been cleared for professional use within 5 m o n t h s . The cholesterol test is t h e first widely distributed blood test to be marketed in this country for home use (the blood glucose test market is, for all practical purposes, restricted to insulin-dependent diabetics). Ammirati says this consideration is likely to have contributed to t h e delay in FDA clearance, although it w a s n ' t discussed d u r i n g t h e clearance process. "The FDA is very concerned right now about making sure t h e clearance c r i t e r i a for optional home-use blood tests are consistent and objective," she explains. "As this test was t h e first one to be cleared, the FDA realized t h a t this test would set t h e p r e c e d e n t for future clearances of home blood tests."
In the wings The total cholesterol test is the first p r o d u c t C h e m T r a k w i l l b r i n g to market, but because the dye reagent can be immobilized on the measurement strip at various concentrations, the length range for color response can be a d j u s t e d to optimize a s s a y sensitivity. Other analytes for which the cassette may be feasible are glucose, ethanol, and various drugs. The company also recently adapted t h e basic cassette technology for a t e s t t h a t m e a s u r e s HDL cholesterol quantitatively by adding filter layers to t h e blood separation device with r e a g e n t s t h a t p r e c i p i t a t e out t h e other lipoproteins. Practically speaking, the total cholesterol test comes to market a little l a t e to get m u c h of a c o m m e r c i a l boost from public hype. Since 1989, when t h e fervor for cholesterol r e duction hit its height, the public h a s been swamped w i t h reports on eve r y t h i n g from the revised s t a t u s of eggs and the controversial merits of oat b r a n to federal a r g u m e n t s over the true meaning of "lite." Still, Singh foresees a real need for the test, because the current average cholesterol level in this country is 210 mg/dL, which means t h a t more t h a n half of all American adults have levels above the desired healthy range and 60 million of those have levels above 240 mg/dL. "The only question left is, will somebody use it?" he says. "The cholesterol craze is not the same as it was three years ago, but the basic problem is still there." Deborah Noble
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ANALYTICAL CHEMISTRY, VOL. 65, NO. 23, DECEMBER 1, 1993 · 1041 A
