CMAJ/JAMC News and analysis
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Warning issued on test kits

CMAJ 1997;157:1010

© 1997 Canadian Medical Association


Health Canada is reminding physicians of potentially fatal misdiagnoses when group B streptococcal (GBS) antigen test kits are used. The Health Protection Branch said GBS antigen tests are only an adjunct to diagnosis and multiple studies have shown they are not an appropriate substitute for bacterial cultures in the diagnosis of GBS colonization or infection. The warning followed a similar alert from the US Food and Drug Administration, which said GBS test kits have produced false-negative results in specimens from pregnant women and infants, who subsequently died from GBS disease.

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| CMAJ October 15, 1997 (vol 157, no 8) / JAMC le 15 octobre 1997 (vol 157, no 8) |