- Email: [email protected]
Screening of genital fluid for Ebola virus – Authors' reply
Correspondence
Screening of genital fluid for Ebola virus Authors’ reply We welcome the opportunity to respond to the letter by William Fischer and colleagues about our Article.1 The main concern expressed in their letter relates to the qRT-PCR assay of the US Centers for Disease Control and Prevention (CDC) used by the Men’s Health Screening Program (MHSP) to test semen samples and appears to be based on their “work validating a different diagnostic platform”. However, Fischer and colleagues do not specify which diagnostic platform and, at the time this response was drafted, they had not published the results of this work. Readers should be aware that as of Nov 25, 2016, no assay or diagnostic platform has been validated by the US Food and Drug Administration or other governing bodies for use with seminal fluid specimens. We certainly agree that evaluation and validation of diagnostic assays and platforms are necessary for every biospecimen type. Evaluation of the US CDC qRT-PCR assay on semen has been done, and the results will be submitted for publication shortly (Ströher and colleagues, unpublished data). Furthermore, this assay has been used previously to test semen samples collected from Ebola virus disease survivors in Sierra Leone2 and in the USA.3 To date, more than 800 individuals and more than 1600 semen specimens have been tested using this assay, without evidence of sexual transmission. Fischer and colleagues also raise concerns about the fact that MHSP “only offers testing to men”. As previously stated, MHSP is a public health programme based on the principles outlined in WHO’s interim guidelines.4 The focus of that guidance is preventing sexual transmission of Ebola virus by men and is based on scientific evidence that has shown Ebola virus persistence in semen and www.thelancet.com/lancetgh Vol 5 January 2017
sexual transmission of Ebola virus by men to their sexual partners.5,6 As of Nov 25, 2016, there have been no reported instances of sexual transmission of Ebola virus by a woman. Nor have there been reports of longterm viral persistence of Ebola virus RNA in vaginal fluids or the detection of infectious virus. Furthermore, no guidance has been released by WHO recommending testing the vaginal fluids of female Ebola virus disease survivors. We agree that further research is warranted in this field. However, in the absence of evidence of a public health risk of female Ebola virus disease survivors transmitting the virus through sex, testing of vaginal fluids in the setting of a public health programme would be premature and could worsen the stigma already faced by Ebola virus disease survivors. We declare no competing interests. Copyright © The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND license.
Moses J Soka, *Mary J Choi, Lawrence J Purpura, Ute Ströher, Barbara Knust, Pierre Rollin, on behalf of all authors of the original study [email protected] Viral Special Pathogens Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA (MJC); Centers for Disease Control and Prevention, Atlanta, GA, USA (LJP, US, BK, MJS, PR) 1
2
3
4
5
6
Soka MJ, Choi MJ, Baller A, et al. Prevention of sexual transmission of Ebola in Liberia through a national semen testing and counselling programme for survivors: an analysis of Ebola virus RNA results and behavioural data. Lancet Glob Health 2016; 4: 736–43. Deen GF, Knust B, Broutet N, et al. Ebola RNA persistence in semen of Ebola virus disease survivors—preliminary report. N Engl J Med 2015; published online Oct 14. DOI:10.1056/ NEJMoa1511410. Uyeki TM, Erickson BR, Brown S, et al. Ebola virus persistence in semen of male survivors. Clin Infect Dis 2016; 62: 1552–55. WHO. Interim advice on the sexual transmission of the Ebola virus disease. 2016. http:///www.who.int/reproductivehealth/ topics/rtis/ebola-virus-semen/en/ (accessed Sept 1, 2015) Rodriguez LL, De Roo A, Guimard Y, et al. Persistence and genetic stability of Ebola virus during the outbreak in Kikwit, Democratic Republic of the Congo, 1995. J Infect Dis 1999; 179 (suppl 1): S170–76. Mate SE, Kugelman JR, Nyenswah TG, et al. Molecular evidence of sexual transmission of Ebola virus. N Engl J Med 2015; 373: 2448–54.
e33
Screening of genital fluid for Ebola virus Authors’ reply We welcome the opportunity to respond to the letter by William Fischer and colleagues about our Article.1 The main concern expressed in their letter relates to the qRT-PCR assay of the US Centers for Disease Control and Prevention (CDC) used by the Men’s Health Screening Program (MHSP) to test semen samples and appears to be based on their “work validating a different diagnostic platform”. However, Fischer and colleagues do not specify which diagnostic platform and, at the time this response was drafted, they had not published the results of this work. Readers should be aware that as of Nov 25, 2016, no assay or diagnostic platform has been validated by the US Food and Drug Administration or other governing bodies for use with seminal fluid specimens. We certainly agree that evaluation and validation of diagnostic assays and platforms are necessary for every biospecimen type. Evaluation of the US CDC qRT-PCR assay on semen has been done, and the results will be submitted for publication shortly (Ströher and colleagues, unpublished data). Furthermore, this assay has been used previously to test semen samples collected from Ebola virus disease survivors in Sierra Leone2 and in the USA.3 To date, more than 800 individuals and more than 1600 semen specimens have been tested using this assay, without evidence of sexual transmission. Fischer and colleagues also raise concerns about the fact that MHSP “only offers testing to men”. As previously stated, MHSP is a public health programme based on the principles outlined in WHO’s interim guidelines.4 The focus of that guidance is preventing sexual transmission of Ebola virus by men and is based on scientific evidence that has shown Ebola virus persistence in semen and www.thelancet.com/lancetgh Vol 5 January 2017
sexual transmission of Ebola virus by men to their sexual partners.5,6 As of Nov 25, 2016, there have been no reported instances of sexual transmission of Ebola virus by a woman. Nor have there been reports of longterm viral persistence of Ebola virus RNA in vaginal fluids or the detection of infectious virus. Furthermore, no guidance has been released by WHO recommending testing the vaginal fluids of female Ebola virus disease survivors. We agree that further research is warranted in this field. However, in the absence of evidence of a public health risk of female Ebola virus disease survivors transmitting the virus through sex, testing of vaginal fluids in the setting of a public health programme would be premature and could worsen the stigma already faced by Ebola virus disease survivors. We declare no competing interests. Copyright © The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND license.
Moses J Soka, *Mary J Choi, Lawrence J Purpura, Ute Ströher, Barbara Knust, Pierre Rollin, on behalf of all authors of the original study [email protected] Viral Special Pathogens Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA (MJC); Centers for Disease Control and Prevention, Atlanta, GA, USA (LJP, US, BK, MJS, PR) 1
2
3
4
5
6
Soka MJ, Choi MJ, Baller A, et al. Prevention of sexual transmission of Ebola in Liberia through a national semen testing and counselling programme for survivors: an analysis of Ebola virus RNA results and behavioural data. Lancet Glob Health 2016; 4: 736–43. Deen GF, Knust B, Broutet N, et al. Ebola RNA persistence in semen of Ebola virus disease survivors—preliminary report. N Engl J Med 2015; published online Oct 14. DOI:10.1056/ NEJMoa1511410. Uyeki TM, Erickson BR, Brown S, et al. Ebola virus persistence in semen of male survivors. Clin Infect Dis 2016; 62: 1552–55. WHO. Interim advice on the sexual transmission of the Ebola virus disease. 2016. http:///www.who.int/reproductivehealth/ topics/rtis/ebola-virus-semen/en/ (accessed Sept 1, 2015) Rodriguez LL, De Roo A, Guimard Y, et al. Persistence and genetic stability of Ebola virus during the outbreak in Kikwit, Democratic Republic of the Congo, 1995. J Infect Dis 1999; 179 (suppl 1): S170–76. Mate SE, Kugelman JR, Nyenswah TG, et al. Molecular evidence of sexual transmission of Ebola virus. N Engl J Med 2015; 373: 2448–54.
e33