|  MedWatch - The FDA Safety Information and Adverse Event Reporting Program The U.S. Food and Drug Administration (FDA) issued a letter to clinical laboratory staff and health care providers about false reactivity, or "false-positive", Rapid Plasma Reagin (RPR; non-treponemal) test results when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit in some people who received a COVID-19 vaccine. Based on information provided by Bio-Rad Laboratories, RPR false reactivity was observed in some individuals for at least five months following a COVID-19 vaccination. COVID-19 vaccines do not cause syphilis. Health care providers should continue to strongly encourage patients to get vaccinated against COVID-19 and be aware of their patients' vaccination status when interpreting reactive RPR test results. Reactive RPR results should always be confirmed with treponemal testing (e.g., Treponema pallidum particle agglutination, TP-PA). The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about the test including: - Details on Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kits having false reactivity test results in some people who have received a COVID-19 vaccine.
- Recommendations for clinical laboratory staff and health care providers.
- Actions the FDA has taken to address the false reactivity.
- Instructions for reporting problems with a medical device to the FDA.
If you have questions about BioPlex 2200 Syphilis Total & RPR having RPR false reactivity following a COVID-19 vaccine, contact the Division of Industry and Consumer Education (DICE) by emailing DICE@FDA.HHS.GOV or calling 800-638-2041 or 301-796-7100. | | | |
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