FDA Safety Alert: Risks of Devices for Direct Detection of Group B Streptococcal Antigen
This is an archived document and is no longer current information.
March 24, 1997
|Clinical Laboratory Directors
Hospital Risk Managers
FDA wants to alert you to potentially fatal misdiagnoses when using test kits to detect group B streptococcal (GBS) antigen, and to provide guidelines on how to appropriately use these tests. GBS disease continues to be a major cause of illness and death among neonates. Antigen tests for GBS have produced false negative results from specimens from pregnant women and infants with subsequent infant deaths from GBS disease. GBS antigen tests have also produced false positive results which may lead to inappropriate antibiotic therapy and prolonged hospitalization.
It is important that clinicians understand the limitations of these devices. Antigen tests are an adjunct to diagnosis and multiple studies have shown that antigen tests are NOT an appropriate substitute for properly performed bacterial culture in the diagnosis of GBS colonization or infection.1-4
Guidelines to be Followed
In order to minimize the likelihood of misdiagnosing GBS infection, we urge that users adhere to the following guidelines. These guidelines should be distributed to all appropriate clinical laboratory personnel, including laboratories in physicians' offices, and physicians and nurses who may use or request these tests. (We have asked manufacturers to notify their customers of the information in this Alert.)
Use in maternity patients
- GBS antigen tests cannot be relied upon to exclude GBS colonization in a pregnant woman. Negative GBS antigen test results should be confirmed using selective broth culture which is more sensitive than antigen tests.
Use in infants
- The only specimens recommended for testing with these devices are blood, serum or cerebrospinal fluid. Testing infant urine with these devices is not recommended.
- These devices should not be used as a substitute for bacteriologic culture in the diagnosis of GBS septicemia and/or meningitis. A positive result indicates only the presence of GBS antigen, and not necessarily the presence of viable organisms. Positive or negative results should be considered presumptive and confirmed by culture.
Additional Background Information
New information on the prevention of GBS disease is described in the recent consensus of the Centers for Disease Control and Prevention (CDC)5, the American College of Obstetricians and Gynecologists6, and the American Academy of Pediatrics7. This consensus resulted in a new standard for detecting GBS colonization in pregnant women. Vaginal/rectal cultures should be obtained at 35-37 weeks of gestation and be performed using selective broth media. The consensus also presented a new algorithm for management of a neonate born to a mother who received intrapartum prophylaxis for prevention of early-onset GBS disease.
FDA has informed manufacturers of test kits for detecting GBS antigen that these devices must be evaluated according to current CDC recommendations as a condition for remaining on the market.
Reporting Adverse Events to FDA
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths and serious illnesses and injuries associated with the use of medical devices. Thus, under the law, an erroneous result from a GBS antigen test kit that results in a death or serious illness must be reported. We request that you follow the procedures established by your facility for such mandatory reporting.
Even if a report is not mandatory, it would be helpful to report directly to MedWatch, the FDA's voluntary reporting program. Submit these reports to MedWatch: by telephone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by mail to:
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at email@example.com or by phone at 1-800-638-2041 or 301-796-7100
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
D. Bruce Burlington, M.D.
Center for Devices and Radiological Health
Food and Drug Administration
1 Baker, C.J. Inadequacy of rapid immunoassays for intrapartum detection of group B streptococcal carriers. Obstetrics & Gynecology, 88: 51-55, 1996.
2 Greenberg, D. N., D. P. Ascher, B. A. Yoder, D. M. Hensley, H.S. Heiman and J. F. Keith, III. Sensitivity and specificity of rapid diagnostic tests for detection of group B streptococcal antigen in bacteremic neonates. J. Clin. Microbio., 33: 193-198, 1995.
3 Perkins, M.D., S. Mirrett and L. B. Reller. Rapid bacterial antigen detection is not clinically useful. J. Clin. Microbio., 33: 1486-1491, 1995.
4 Williamson, M., S. H. Fraser and J. Tilse. Failure of the urinary group B streptococcal antigen test as a screen for neonatal sepsis. Arch. Dis. Childhood, 73: F109-111, 1995.
5 Centers for Disease Control and Prevention. Prevention of perinatal group B streptococcal disease: A public health perspective. In Morbidity and Mortality Weekly Report (MMWR), Recommendations and Reports, Vol. 45, RR-7, May 31, 1996. Erratum: MMWR, Vol. 45, No. 31, 1996.
6 American College of Obstetricians and Gynecologists. Prevention of early-onset disease in the newborn due to group B streptococcus. ACOG Committee Opinion, No. 173, 1996.
7 American Academy of Pediatrics. Revised guidelines for prevention of early-onset group B streptococcal infection. Pediatrics, 99: 489-496, 1997.