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<p class="MsoNormal">Dear Prevention Partners,<o:p></o:p></p>
<p class="MsoNormal"><br>
Please see the below message from CDC and FDA regarding the potential for “false positive” syphilis test results conducted using the
<i>Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit</i>. Please note that syphilis specimens tested through Oregon State Public Health Lab do not use the Bio-Rad testing platform to test for syphilis.
<o:p></o:p></p>
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<p class="MsoNormal" align="right" style="text-align:right"><span style="font-family:"Arial",sans-serif">December 20, 2021<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
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<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">Dear Partners in Prevention,
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">I’m writing to share the
<a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ft.emailupdates.cdc.gov%2Fr%2F%3Fid%3Dh58fd69e5%2C158f0742%2C158f3712%26ACSTrackingID%3DUSCDCNPIN_122-DM72406%26ACSTrackingLabel%3DFDA%2520Alert%253A%2520Possible%2520False%2520RPR%2520Reactivity%2520with%2520Syphilis%2520Test&data=04%7C01%7Cjoshua.s.ferrer%40dhsoha.state.or.us%7Cd5c0d2df1a254524f26208d9c3e2c503%7C658e63e88d39499c8f4813adc9452f4c%7C0%7C0%7C637756201002487345%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=zRWpfowkWLZHZD8rcfUrdByZ7Y6rU%2Bo8TT9GWTboz8w%3D&reserved=0">
U.S. Food and Drug Administration (FDA) alert</a> sent to clinical laboratory staff and health care providers about a syphilis test. The alert reports that 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, can occur in some people who received a COVID-19 vaccine and includes recommendations for addressing these potential false positives.
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">Historically, false-reactive RPR test results have been observed in people with systemic infections unrelated to syphilis, such as tuberculosis,
rickettsial diseases, and endocarditis. False-reactive RPR testing also has been previously observed following immunization (specifically following smallpox vaccine). False reactivity with RPR can also occur during pregnancy.
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">Per CDC’s
<a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ft.emailupdates.cdc.gov%2Fr%2F%3Fid%3Dh58fd69e5%2C158f0742%2C158f3713%26ACSTrackingID%3DUSCDCNPIN_122-DM72406%26ACSTrackingLabel%3DFDA%2520Alert%253A%2520Possible%2520False%2520RPR%2520Reactivity%2520with%2520Syphilis%2520Test&data=04%7C01%7Cjoshua.s.ferrer%40dhsoha.state.or.us%7Cd5c0d2df1a254524f26208d9c3e2c503%7C658e63e88d39499c8f4813adc9452f4c%7C0%7C0%7C637756201002487345%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=dQb1BJDVCTWE6RwZfg9fM0DlaM1j7QEIfYn8DcH013Q%3D&reserved=0">
2021 STI Treatment Guidelines</a>, reactive RPR results should always be confirmed with treponemal testing (e.g.,
<i>Treponema pallidum</i> particle agglutination, TP-PA). This is, in part, because of the above-mentioned issue: false-positive nontreponemal test results can be associated with multiple medical conditions and factors unrelated to syphilis. According to FDA’s
alert, treponemal testing for syphilis does not appear to be impacted by this issue.
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">As
<a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ft.emailupdates.cdc.gov%2Fr%2F%3Fid%3Dh58fd69e5%2C158f0742%2C158f3714%26ACSTrackingID%3DUSCDCNPIN_122-DM72406%26ACSTrackingLabel%3DFDA%2520Alert%253A%2520Possible%2520False%2520RPR%2520Reactivity%2520with%2520Syphilis%2520Test&data=04%7C01%7Cjoshua.s.ferrer%40dhsoha.state.or.us%7Cd5c0d2df1a254524f26208d9c3e2c503%7C658e63e88d39499c8f4813adc9452f4c%7C0%7C0%7C637756201002487345%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=NMp4zu5JaeW6fouz00viZpVCr45Y4ctHRJ5z07Dr4Jo%3D&reserved=0">
syphilis continues to increase</a> in our nation, it is critical that patients receive timely and adequate treatment. According to
<a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ft.emailupdates.cdc.gov%2Fr%2F%3Fid%3Dh58fd69e5%2C158f0742%2C158f3715%26ACSTrackingID%3DUSCDCNPIN_122-DM72406%26ACSTrackingLabel%3DFDA%2520Alert%253A%2520Possible%2520False%2520RPR%2520Reactivity%2520with%2520Syphilis%2520Test&data=04%7C01%7Cjoshua.s.ferrer%40dhsoha.state.or.us%7Cd5c0d2df1a254524f26208d9c3e2c503%7C658e63e88d39499c8f4813adc9452f4c%7C0%7C0%7C637756201002487345%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=W%2BhUMRKwEkQMn1cuxxi1Kho2C10Ezd5lmye3XasXSxc%3D&reserved=0">
CDC guidance</a>, some people may need presumptive treatment for early syphilis, even if test results are not immediately available. Providers should consider the patient’s risk factors, as well as local epidemiology, when making treatment decisions.
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">If you need clinical decision-making support, you can reach out to CDC clinicians via
<a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ft.emailupdates.cdc.gov%2Fr%2F%3Fid%3Dh58fd69e5%2C158f0742%2C158f3716%26ACSTrackingID%3DUSCDCNPIN_122-DM72406%26ACSTrackingLabel%3DFDA%2520Alert%253A%2520Possible%2520False%2520RPR%2520Reactivity%2520with%2520Syphilis%2520Test&data=04%7C01%7Cjoshua.s.ferrer%40dhsoha.state.or.us%7Cd5c0d2df1a254524f26208d9c3e2c503%7C658e63e88d39499c8f4813adc9452f4c%7C0%7C0%7C637756201002487345%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=UEgwissjagBXckvSfKzRjNKHCFoY%2F7OIWsurDLT3%2Bcw%3D&reserved=0">
CDC-INFO</a>, or you can contact the <a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Ft.emailupdates.cdc.gov%2Fr%2F%3Fid%3Dh58fd69e5%2C158f0742%2C158f3717%26ACSTrackingID%3DUSCDCNPIN_122-DM72406%26ACSTrackingLabel%3DFDA%2520Alert%253A%2520Possible%2520False%2520RPR%2520Reactivity%2520with%2520Syphilis%2520Test&data=04%7C01%7Cjoshua.s.ferrer%40dhsoha.state.or.us%7Cd5c0d2df1a254524f26208d9c3e2c503%7C658e63e88d39499c8f4813adc9452f4c%7C0%7C0%7C637756201002487345%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=USSDGfrk%2FZhx%2BWEF%2BgiJaTiaChdBz0IWLEZu%2FLaRW%2Fc%3D&reserved=0">
STD Clinical Consultation Network</a>. For general laboratory information or additional support/guidance on specific testing requirements, please contact DSTDP’s STD Laboratory Reference and Research Branch via Weiping Cao (<a href="mailto:jgz9@cdc.gov">jgz9@cdc.gov</a>),
Syphilis/Emerging STIs Team Lead, or Ellen Kersh (<a href="mailto:egk6@cdc.gov">egk6@cdc.gov</a>), Branch Chief.
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">FDA encourages health care providers to report adverse events or suspected adverse events experienced with medical devices, including in vitro diagnostic
tests, and the alert linked above includes contact information.<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">Thank you for your continued collaboration,
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">/Leandro Mena/
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">Leandro Mena, MD, MPH
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">Director, Division of STD Prevention
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">National Center for HIV, Viral Hepatitis, STD, and TB Prevention
<o:p></o:p></span></p>
<p class="MsoNormal" style="text-align:justify;line-height:15.0pt"><span style="font-family:"Arial",sans-serif">US Centers for Disease Control and Prevention<o:p></o:p></span></p>
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