Subject: Early Abbott Test For AIDS Is Probed 
Date: Published: 1/27/92 (75 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    Early Abbott Test
    For AIDS Is Probed
    By Rep. Dingell
    ----
    By Thomas M. Burton
    Staff Reporter of The Wall Street Journal

    NORTH CHICAGO, Ill.  -- Rep. John Dingell (D., Mich.)  is
 investigating whether alleged deficiencies in an early AIDS
 test made by Abbott Laboratories led to contaminations of the
 U. S. blood supply.
    Mr. Dingell, chairman of the House Energy and Commerce
 Committee, asked Abbott for information about the early test
 in a letter to the company last week.  That test was sold by
 Abbott to the Red Cross, blood banks and hospitals for
 several months in 1985 and 1986.  Abbott is still the leading
 manufacturer of the AIDS test, but is today making a
 different version.
    Rep. Dingell has asked the company about the possibility
 that its early test produced so-called false negatives.  Such
 tests would show a blood sample as being uncontaminated, even
 though the sample in fact contained the AIDS virus.
    In such a case, an unwitting patient could receive blood
 during surgery and contract AIDS.  Abbott has been named a
 defendant in a lawsuit alleging this occurred in at least one
 instance.
    Some California health authorities concluded that the
 Abbott test produced some false negatives in samples of blood
 taken from the San Francisco area in 1986.  The samples came
 largely from members of the homosexual community, one that is
 heavily at risk for contracting AIDS.  Thus the samples had a
 higher likelihood of including some with the AIDS virus.
    The phenomenon of false negatives has been known about
 since the early days of the AIDS test.  So, too, the existence
 of "false positives" has been known, which can lead to blood
 banks throwing out uncontaminated blood.
    Abbott was one of five manufacturers who received samples
 of the AIDS virus from the U. S. government so it could
 manufacture a test for the disease.  It was the first to
 receive approval from the federal Food and Drug
 Administration.
    Then and now, there is known to be a period of several
 months during which a person could have recently acquired the
 AIDS virus, yet still test negative.  Blood from such a donor
 could still find its way into the country's blood supply
 network for use in surgical procedures, transfusions and the
 like.
    While the tests have become more advanced since their
 invention, doctors still say that recipients of blood can
 become infected this way, but that the chances are slight of
 this happening.
    Doctors estimate that nowadays one in between 40,000 and
 150,000 units of blood can be contaminated with the AIDS
 virus as a result of this shortcoming in the test.  The virus,
 too, can be contracted through organ and tissue transplants,
 including bone grafts and the like.  Doctors estimate there is
 a minimal chance of contracting AIDS this way, too -- a risk
 about equivalent to the chance of acquiring the virus through
 blood transfusions.
    Abbott, which makes hospital supply products, as well as
 pharmaceutical and diagnostic equipment, declined comment on
 the Dingell inquiry and on the lawsuit alleging deficiencies
 in its early test.  Abbott said it couldn't immediately
 provide any broad-based data on how its numbers of false
 negatives in early tests compared to those in tests made by
 other manufacturers.

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