Recommendations for Assessment of 
Blood Donor Eligibility, Donor 
Deferral and Blood Product 
Management in  
Response to Ebola Virus 
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or 
from the Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
January 2017  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  RECOMMENDATIONS .................................................................................................. 3 
A.  Donor Educational Material and Donor History Questionnaire ...................... 4 
B.  Donor Deferral ...................................................................................................... 5 
C.  Product Retrieval, Quarantine, and Notification............................................... 6 
IV.  REPORTING A BIOLOGICAL PRODUCT DEVIATION (BPD) ............................. 7 
V.  CONVALESCENT PLASMA ......................................................................................... 8 
VI.  IMPLEMENTATION ...................................................................................................... 9 
VII.  REFERENCES ................................................................................................................ 11 
 
 
i  Contains Nonbinding Recommendations 
 
Recommendations for Assessment of Blood Donor Eligibility, Donor 
Deferral and Blood Product Management in Response to  
Ebola Virus 
 
 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page.  
 
 
I.  INTRODUCTION 
 
We, FDA, are notifying you, blood establishments that collect blood and blood components for 
transfusion or further manufacture, including Source Plasma, that we have determined Ebola 
virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal 
Regulations (CFR) 630.3(l).  We are also providing you with recommendations for assessing 
blood donor eligibility, donor deferral and blood product management in the event that an 
outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one 
country.  This guidance document applies to Ebola virus (species Zaire ebolavirus).1  The 
recommendations in section III. of this guidance document apply to the routine collection of 
blood and blood components for transfusion or further manufacture, including Source Plasma.  
The collection of convalescent plasma from EVD survivors is addressed in section V. of this 
guidance document.  This guidance finalizes the draft guidance entitled, Recommendations for 
Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in 
Response to Ebola Virus, dated December 2015. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDAs guidances means that something is suggested or 
recommended, but not required. 
 
 
                                                           
1 FDA will assess whether the recommendations apply to other viruses of the Ebolavirus genus should widespread 
transmission of such viruses occur. 
1  Contains Nonbinding Recommendations 
 
II.  BACKGROUND  
 
Ebola virus is a member of the family Filoviridae that can cause severe hemorrhagic fever in 
humans and non-human primates (NHPs) with historically high morbidity and mortality rates of 
up to 90% (Refs. 1 and 2).  However, in the 2014 outbreak in West Africa, the mortality rate was 
lower, with 28,652 suspected, probable, and confirmed cases, including 15,261 laboratory-
confirmed cases, and 11,325 deaths reported as of April 2016.2  Ebola virus is a lipid-enveloped 
zoonotic pathogen that, when studied in the laboratory, requires the highest level of biosafety 
containment (BSL-4).  The Centers for Disease Control and Prevention (CDC) has classified it as 
a Category A bioterrorism agent/disease.3  Ebola virus is reported to be inactivated by heating 
at 60oC for 60 minutes, and also following incubation at pH 2.5 (Ref. 3).  Solvent-detergent 
treatment and pathogen inactivation technologies are also known to inactivate lipid-enveloped 
viruses (Refs. 4 through 8). 
 
In humans, EVD is typically characterized at onset by fever, severe headache, muscle pain and 
weakness, followed by diarrhea, vomiting, abdominal pain and sometimes diffuse hemorrhage 
(bleeding or bruising).  In previous outbreaks of EVD, symptoms generally appeared within 21 
days and most often within 4-10 days following infection (Refs. 9 and 10).  Based on 
mathematical models, symptom onset later than 21 days is estimated as possible in 0.1 to 12% of 
cases (Refs. 10 and 11).  In a retrospective study in which 500 patients diagnosed with EVD in 
2014 recalled their likely source of infection, 5% reported symptom onset > 21 days (up to a 
maximum of 43 days) post-exposure (Ref. 10). 
 
Viremia and virus shedding escalate rapidly after onset of symptoms and infectivity appears to 
correlate with severity and stage of disease.  Although viremia in survivors typically resolves 
within 21 days of disease onset, infectious virus and viral RNA has been detected in other body 
components or fluids (e.g., aqueous humor, semen and vaginal fluids) for longer periods.  For 
instance, viable Ebola virus was detected in aqueous humor obtained from the eye 14 weeks after 
the onset of the initial symptoms of EVD and 9 weeks after the clearance of viremia (Ref. 12).  
Infectious virus and viral RNA have been detected in semen up to 82 and 272 days post EVD 
onset, respectively (Refs. 13 through 17).4  Further, a case of sexual transmission of Ebola virus 
was reported in which the patient was exposed to Ebola virus through sexual contact with a 
survivor 179 days after likely disease onset (Refs. 18 and 19).  These findings raise the 
theoretical possibility, which has not been documented in humans or animal models, of an 
intermittent low level viremia after recovery from illness.  In addition, there have been isolated 
reports of apparently asymptomatic Ebola virus infection in individuals who had contact with 
Ebola patients (Ref. 18), and of antibody to Ebola virus in rural African populations reportedly 
unassociated with acute illness (Ref. 19).  These reports raise the possibility that there may be an 
asymptomatic infection or mild disease in some individuals; if this condition exists, the 
infectivity of these individuals is uncertain but likely to be less than that of severely ill persons. 
 
                                                           
2 See CDC website:  http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/case-counts.html. 
3 See CDC website:  http://emergency.cdc.gov/bioterrorism/overview.asp#categories. 
4 See also the CDC Review of Human-to-Human Transmission of Ebola Virus, 
http://www.cdc.gov/vhf/ebola/transmission/human-transmission.html. 
2  Contains Nonbinding Recommendations 
 
Ebola virus is transmitted from human to human by direct contact with body fluids (such as 
blood, urine, stool, saliva, semen, vaginal fluids or vomit) of symptomatic infected individuals.  
Therefore, blood and blood products from symptomatic individuals, if they were to donate, 
would have the potential of transmitting Ebola virus to recipients.  The theoretical possibility of 
pre-symptomatic viremia has not been extensively investigated.  If this condition exists the 
infectivity is uncertain, but likely to be less than of symptomatic persons.  Healthcare providers 
caring for symptomatic Ebola patients, and family and friends in close contact with symptomatic 
Ebola patients, are at the highest risk of becoming infected because they may come in direct 
contact with infected blood or other body fluids of sick patients.  Because of the severity of the 
disease and the risk of transmission by blood and blood products, we have determined that Ebola 
virus meets the definition of TTI in 21 CFR 630.3(l).5 
 
 
III.  RECOMMENDATIONS 
 
Under 21 CFR 630.10(a), a donor must be in good health and free from TTIs.  A donor must also 
have a normal temperature at the time of donation (21 CFR 630.10(f)(1)).  Additionally, under 
21 CFR 630.10(a) a donor is not eligible if you identify any factor(s) that may cause the donation 
to adversely affect the safety, purity, or potency of the blood or blood component.  Such factors 
include symptoms of a recent or current illness, as well as travel to, or residence in, an area 
endemic for a TTI (21 CFR 630.10(e)(2)(i) and (iii)).   
 
Standard procedures that are already in place to assure that the donor is healthy at the time of 
donation serve as an effective safeguard against collecting blood or blood components from a 
donor who seeks to donate after the onset of clinical symptoms of EVD.  The following 
recommendations are intended to reduce the risks of collecting blood and blood components 
from potentially Ebola virus-infected persons during the asymptomatic incubation period before 
the onset of clinical symptoms, as well as from individuals with a history of Ebola virus infection 
or disease. 
 
This guidance contains a recommendation for updating your donor educational materials in 
section III.A.1.  The recommendations in section III.A.2. and III.B. should be implemented when 
the CDC has classified one or more countries as having widespread transmission of Ebola virus.  
We recommend that you continue to follow the recommendations for 4 weeks after the date CDC 
classifies the last affected country as a country with former widespread transmission.  After this 
period, when there are no countries classified by CDC as having widespread transmission of 
Ebola virus, it is appropriate to discontinue asking donors questions related to risk of Ebola virus 
infection or disease.  (See http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/distribution-
map.html for CDCs classification of countries with reported Ebola cases and for the specific 
dates when a country is classified as a country with former widespread transmission of Ebola 
virus.)   
 
                                                           
5 We have determined that Ebola virus does not meet the definition of a relevant transfusion-transmitted infection 
because it may not have sufficient incidence and/or prevalence to affect the potential donor population (see  
21 CFR 630.3(h)(2)(ii)(A)). 
3  Contains Nonbinding Recommendations 
 
A.  Donor Educational Material and Donor History Questionnaire  
 
1.  Donor Educational Material 
 
We expect very few individuals with a history of Ebola virus infection or disease 
to present as blood donors.  When there are no countries classified by CDC as 
having widespread transmission of Ebola virus, self-deferral of donors with a 
history of Ebola virus infection or disease should provide sufficient protection.  
We recommend that you update your donor educational materials to instruct 
donors with a history of Ebola virus infection or disease to not donate blood or 
blood components. 
 
2.  Donor History Questionnaire  
 
In the event that one or more countries is classified by CDC as having widespread 
transmission of Ebola virus, your donor history questionnaire (DHQ), including 
your full-length and abbreviated DHQ, and accompanying materials, must 
incorporate elements to assess prospective donors for symptoms of recent or 
current illness with Ebola virus infection or disease, and travel to, or residence in, 
an area endemic for Ebola virus in accordance with 21 CFR 630.10(e)(2).  We 
recommend that your DHQ assess donors for:   
 
a.  A history of Ebola virus infection or disease. 
 
b.  A history of residence in or travel in the past 8 weeks to a country with 
widespread transmission of EVD or cases in urban areas with uncertain 
control measures.  (See http://www.cdc.gov/vhf/ebola/outbreaks/2014-
west-africa/distribution-map.html). 
 
In addition, we also recommend that the updated DHQ include the following 
elements to further assess prospective donors for risk of Ebola virus infection or 
disease: 
 
a.  A history of close contact in the past 8 weeks with a person confirmed to 
have Ebola virus infection or disease or a person under investigation (PUI) 
for Ebola virus infection or disease in whom diagnosis is pending.  For the 
purposes of this guidance, close contact is defined as contact that could 
have resulted in direct exposure to body fluids.  Individuals falling into 
this close contact category include healthcare workers and other persons 
who care for, have lived with, or have otherwise been in contact with a 
PUI or a person confirmed to have Ebola virus infection or disease.6 
                                                           
6 For additional information on epidemiologic risk factors to consider when evaluating a person for exposure to 
Ebola virus see:  http://www.cdc.gov/vhf/ebola/exposure/risk-factors-when-evaluating-person-for-exposure.html.  
We expect individuals in the high risk, some risk, and low risk categories would fall into this close contact 
category. 
4  Contains Nonbinding Recommendations 
 
 
  Additionally, this close contact category includes individuals with 
a history of sexual contact in the past 8 weeks with a person known 
to have recovered from EVD prior to that instance of sexual 
contact, regardless of the time since the persons recovery.  
 
b.  A history of notification by a public health authority that he or she may 
have been exposed in the past 8 weeks to a person with EVD.  
 
We note that educational material may assist donors in assessing their risk factors 
for Ebola virus infection or disease as described above.  Relevant information on 
risk factors can be found on CDCs website at http://www.cdc.gov/vhf/ebola. 
 
B.  Donor Deferral 
 
You must defer a donor found to be ineligible because of symptoms of a recent or current 
illness, as well as travel to, or residence in an area endemic for a TTI, including Ebola 
virus (21 CFR 630.10(e)(2) and (h)).  We recommend the following deferral periods for 
such donors: 
 
1.  Indefinite7 deferral of a donor with a history of Ebola virus infection or 
disease. 
 
Note:  This recommendation excludes the collection of convalescent plasma 
for treatment of EVD as described in section V. of this guidance. 
 
2.  Eight week8 deferral from the date of his or her departure a donor who has 
been a resident of or has travelled to a country with widespread transmission 
of EVD or with cases in urban areas with uncertain control measures.  (See 
http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/distribution-
map.html.) 
 
Note:  Longer deferral periods may apply based on recommendations for 
deferral due to risk of malaria exposure.  See FDA document entitled, 
Guidance for Industry:  Recommendations for Donor Questioning, Deferral, 
Reentry and Product Management to Reduce the Risk of Transfusion-
Transmitted Malaria, dated August 2014. 
http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinf
ormation/guidances/blood/ucm365191.htm. 
 
                                                           
7 Until more data regarding the persistence of Ebola virus in survivors becomes available, we recommend you defer 
such donors indefinitely. 
8 Although symptoms generally appear within 21 days of infection, we recommend an extended deferral period of 8 
weeks to prevent blood and blood component collection from an individual who could be infected and have an 
extended incubation period.  In addition, 8 weeks is consistent with the inter-donation interval for Whole Blood 
donations.   
5  Contains Nonbinding Recommendations 
 
In addition, we recommend the following additional deferral periods: 
 
1.  Eight week8 deferral after the last contact a donor who has had close contact 
with a person confirmed to have Ebola virus infection or disease or a PUI in 
whom the diagnosis is pending.  Individuals falling into this category include 
healthcare workers and other persons who care for, or have lived with, or 
person confirmed to have Ebola virus infection or disease or a PUI.5  
 
  In addition, we recommend that you defer for 8 weeks8after the last 
sexual contact a donor who has had sexual contact with a person 
known to have recovered from EVD regardless of the time since the 
persons recovery.9  
 
2.  Eight week deferral after exposure8 a donor who has been notified by a 
federal, state, or local public health authority that he or she may have been 
exposed to a person with EVD. 
 
C.  Product Retrieval, Quarantine, and Notification 
 
1.  Blood and Blood Components Collected from Donors at Risk for Ebola Virus 
Infection or Disease Because of Risk Factors Related to Residency, Travel or 
Close Contact 
 
If you collected blood or blood components intended for transfusion or further 
manufacture into injectable and non-injectable products from a donor who should 
have been deferred for risk factors for EVD related to residency, travel, or close 
contact, according to the recommendations in section III.B. of this document, we 
recommend that you quarantine and destroy all undistributed in-date blood and 
blood components from that donor.   
 
a.  If you distributed blood or blood components intended for transfusion or 
for further manufacture into injectable and non-injectable products from a 
donor who should have been deferred for risk factors for EVD related to 
residency, travel or close contact according to the recommendations in 
section III.B. of this document, we recommend that you notify consignees 
to retrieve, quarantine and destroy the in-date blood and blood 
components collected from that donor.   
 
b.  We do not recommend retrieval or quarantine of plasma pooled for further 
manufacturing into products that are manufactured under processes that 
include multiple validated viral inactivation and clearance steps, which 
                                                           
9 Until additional data regarding the length of time semen could be infectious post EVD becomes available, we 
recommend that you defer for 8 weeks after the last sexual contact a donor who has had sexual contact with a person 
known to have recovered from EVD. 
6  Contains Nonbinding Recommendations 
 
have been shown to be robust in the inactivation and clearance of lipid-
enveloped viruses.   
 
2.  Blood and Blood Components Collected from Donors Later Determined to 
Have Ebola Virus Infection or Disease 
 
We recommend you contact FDA10 as soon as possible upon learning that you 
collected blood or blood components from a donor later determined to have 
Ebola virus infection or disease.  This recommendation applies to the 
collection of blood components in the 8 weeks prior to disease onset or any 
time after disease onset.  In addition, blood establishments should consider the 
need to notify state and local public health authorities. 
 
a.  If you collected blood or blood components within a recommended 
deferral period as specified in section III.B. of this document from a donor 
later determined to have Ebola virus infection or disease, you should 
promptly retrieve and quarantine the blood and blood components 
collected in the 8 weeks prior to disease onset and any time after disease 
onset.   
 
  If such blood components were transfused, we recommend that 
consignees notify the transfusion recipients physician of record 
regarding the need for notification and monitoring of the recipient 
for possible Ebola virus infection or disease. 
 
b.  Manufacturers should contact the appropriate FDA review division to 
discuss their conduct of an adequate risk analysis if plasma collected from 
a donor later determined to have Ebola virus infection or disease has been 
pooled for further manufacturing or manufactured into a finished product.  
Finished products manufactured from such plasma pools should not be 
released prior to completion of an adequate risk analysis demonstrating  
that the product will not place patients at risk of EVD.  Finished products 
manufactured from such plasma pools that have already been released 
should also undergo a risk analysis. 
 
 
IV.  REPORTING A BIOLOGICAL PRODUCT DEVIATION (BPD) 
 
If you have distributed blood or blood components for transfusion or further manufacture 
collected from a donor at risk for or known to have Ebola virus infection or disease according to 
section III.B. of this document, you should report a BPD as soon as possible but you must report 
at a date not to exceed 45 calendar days from the date you acquire the information reasonably 
suggesting that a reportable event has occurred (21 CFR 606.171). 
                                                           
10 Contact CBERs Office of Communication, Outreach and Development (OCOD) by calling 1-800-835-4709 or 
240-402-8010.  After regular business hours and on weekends, call the FDA emergency number:  1-866-300-4374 
or 301-796-8240.  
7  Contains Nonbinding Recommendations 
 
 
If you have distributed finished products manufactured from blood or blood components 
collected from a donor later determined to have Ebola virus infection or disease according to 
section III.B. of this guidance, you should report a BPD as soon as possible but you must report 
at a date not to exceed 45 calendar days from the date you acquire the information reasonably 
suggesting that a reportable event has occurred (21 CFR 600.14). 
 
 
V.  CONVALESCENT PLASMA 
 
As of the date of issuance of this guidance, there are no FDA-approved therapeutics or licensed 
vaccines for EVD.  Standard treatment for EVD is limited to supportive care, which includes 
intravenous fluids and electrolytes, treatment of secondary infections, and pain control. 
 
Serum and plasma therapies have been used to treat many infectious diseases, including Junin 
Virus, a virus that also causes hemorrhagic fever (Ref. 22).  There is similar interest in whether 
convalescent serum or plasma collected from EVD survivors may be an effective therapy in 
Ebola virus outbreaks.  Neutralizing antibodies are generated during filovirus infection in 
humans (Ref. 23).  Ebola virus-infected individuals develop humoral immune responses (Ref. 
24) that include neutralizing antibodies in some survivors.  In previous studies conducted using 
non-human primates, passive transfer of certain neutralizing monoclonal antibodies (Refs. 25 
and 26) and convalescent immunoglobulin concentrate prepared from non-human primates that 
were vaccinated and virus challenged (Ref. 27) have resulted in protection against lethal 
challenge with Ebola virus.  However, whole blood from Ebola virus vaccinated and challenged 
monkeys did not protect against Ebola virus challenge in non-human primates (Ref. 28).  
 
Treatment of EVD patients with convalescent human sera has been used in uncontrolled studies 
(Refs. 29 through 31).  Based on the available scientific evidence, the World Health 
Organization (WHO) has developed interim guidance for national health authorities and blood 
transfusion services, entitled, Use of Convalescent Whole Blood or Plasma Collected from 
Patients Recovered from Ebola Virus Disease for Transfusion, as an Empirical Treatment during 
Outbreaks, dated September 2014, 
http://www.who.int/csr/resources/publications/ebola/convalescent-treatment/en/.   
 
As noted above, this investigational treatment has not yet been proven to be effective and results 
of a clinical trial in Guinea were negative (Ref. 32).  However, the effectiveness of convalescent 
plasma or immune globulin concentrates made from convalescent plasma remains biologically 
plausible and further studies may still be considered.  Convalescent plasma or serum collected 
from donors who have recovered from EVD is an investigational product, and controlled studies 
with an adequate number of patients are needed to assess safety and effectiveness.  Blood 
establishments wishing to collect or distribute convalescent plasma intended for transfusion in 
the United States must submit an investigational new drug application in accordance with  
8  Contains Nonbinding Recommendations 
 
21 CFR Part 312, and sponsors seeking to develop devices containing convalescent plasma are 
subject to the investigational device regulations in 21 CFR Part 812 (see 21 CFR 601.21).  Such 
sponsors should contact FDA to discuss the submission.11   
 
 
VI.  IMPLEMENTATION 
 
We recommend that you revise your donor education materials consistent with recommendations 
in section III.A.1 no later than 12 weeks after the guidance issue date.  The revisions to the donor 
history questionnaire and accompanying materials described in section III.A.2 should be 
implemented within 4 weeks of the date that CDC classifies one or more countries as having 
widespread transmission of Ebola virus. 
 
Licensed manufacturers must report the implementation of the recommendations in this guidance 
to FDA under 21 CFR 601.12 as follows:  
 
1.  Revision of your donor educational materials must be reported in an Annual Report under 
21 CFR 601.12(d), noting the date the process was implemented.  See  
21 CFR 601.12(a)(3). 
 
2.  Revision of your own DHQ and accompanying materials must be reported in an Annual 
Report under 21 CFR 601.12(d), noting the date the process was implemented.  See  
21 CFR 601.12(a)(3). 
 
3.  Revision of an FDA accepted DHQ and accompanying materials according to the 
directions in the User Brochure or Directions for Use must be reported in an Annual 
Report under 21 CFR 601.12(d), noting the date the process was implemented.  See  
21 CFR 601.12(a)(3). 
 
4.  Revision of an FDA accepted DHQ and accompanying materials other than as described 
in section VI.2 of this guidance is considered a major change.  If you wish to implement 
the acceptable DHQ documents modified in a manner other than as described in section 
VI.3 of this guidance, you must report such changes as a Prior Approval Supplement 
(PAS) under 21 CFR 601.12(b). 
 
We recommend that you include the following in the PAS submission:  
 
a.  Form FDA 356h Application to Market a New or Abbreviated New Drug, or 
Biologic for Human Use which may be obtained at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm; 
b.  A cover letter describing the request and the contents of the submission;  
                                                           
11 Please contact the appropriate review division in CBER in accordance with CBER SOPP 8101.1:  Scheduling and 
Conduct of Regulatory Review Meetings with Sponsors and Applicants.  See 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm07
9448.htm.   
9  Contains Nonbinding Recommendations 
 
c.  A written standard operating procedure (SOP) describing the donor questions and 
questionnaire process; and  
d.  The donor history questionnaires and accompanying document(s).  Please 
highlight the modifications.  
 
 
10  Contains Nonbinding Recommendations 
 
VII.  REFERENCES 
 
1.  Feldmann, H., Jones, S., Klenk, H.D., et al., Ebola Virus: from Discovery to Vaccine. 
Nature Review, Immunology, 2003; 3:677-685. 
 
2.  Towner, J.S., Sealy, T.K., Khristova, M.L., et al., Newly Discovered Ebola Virus 
Associated With Hemorrhagic Fever Outbreak in Uganda, PLoS pathogens, 2008; 
4:e1000212. 
 
3.  Mitchell, S.W., McCormick, J.B., Physicochemical inactivation of Lassa, Ebola, and 
Marburg Viruses and Effect on Clinical Laboratory Analyses, J Clin Microbiol, 1984; 
20:486-489. 
 
4.  Horowitz, B., Bonomo, R., Prince, A.M., et al., Solvent/Detergent-Treated Plasma: a 
Virus-Inactivated Substitute for Fresh Frozen Plasma, Blood, 1992; 79:826-831. 
 
5.  Dichtelmuller, H., et al., Robustness of Solvent/Detergent Treatment of Plasma 
Derivatives: A Data Collection from Plasma Protein Therapeutics Association Member 
Companies, Transfusion, 2009; 49:1931-1943. 
 
6.  El-Ekiaby, M., et al., Solvent-Detergent Filtered (S/D-F) Fresh Frozen Plasma and 
Cryoprecipitate Minipools Prepared in a Newly Designed Integral Disposable Processing 
Bag System, Transfusion Medicine, 2010; 20:48-61. 
 
7.  Singh, Y., et al., Photochemical Treatment of Plasma with Amotosalen and Long 
Wavelength Ultraviolet Light Inactivates Pathogens While Retaining Coagulation 
Function, Transfusion, 2006; 46:1168-1177. 
 
8.  Lin, L., et al., Inactivation of Viruses in Platelet Concentrates by Photochemical 
Treatment with Amotosalen and Long-Wavelength Ultraviolet Light, Transfusion, 2005; 
45:580-590.  
 
9.  Eichner, M., Dowell, S.F., Firese, N., Incubation Period of Ebola Hemorrhagic Virus 
Subtype Zaire, Osong Public Health Res Perspect, 2011; 2:3-7. 
 
10.  World Health Organization Ebola Response Team.  Ebola Virus Disease in West Africa-
-the First 9 Months of the Epidemic and Forward Projections, N Engl J Med, 2014; 
371:1481-1495. 
 
11.  Haas, C.N., On the Quarantine Period for Ebola Virus, PLOS Currents Outbreaks.  
2014 Oct 14, 1st ed. 
 
12.  Varkey, J.B., et al., Persistence of Ebola Virus in Ocular Fluid during Convalescence, 
N Engl J Med, 2015; 372:2423-2437. 
 
11  Contains Nonbinding Recommendations 
 
13.  Bausch, D.G., Towner, J.S., Dowell, S.F., et al., Assessment of the Risk of Ebola Virus 
Transmission from Bodily Fluids and Fomites, The Journal of Infectious Diseases, Nov 
15, 2007; 196 Suppl 2:S142-147. 
 
14.  Rodriguez, L.L., 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, 
The Journal of Infectious Diseases, Feb 1999; 179 Suppl 1:S170-176.4. 
 
15.  Rowe, A.K., Bertolli, J., Khan, A.S., et al., Clinical, Virologic, and Immunologic 
Follow-Up of Convalescent Ebola Hemorrhagic Fever Patients and Their Household 
Contacts, Kikwit, Democratic Republic of the Congo.  Commission de Lutte contre les 
Epidemies a Kikwit, The Journal of Infectious Diseases, Feb 1999; 179 Suppl 1:S28-35. 
 
16.  Richards, G.A., Murphy, S., Jobson, R., et al., Unexpected Ebola virus in a Tertiary 
Setting: Clinical and Epidemiologic Aspects, Critical Care Medicine, Jan 2000; 
28(1):240-244. 
 
17.  Deen, G.F. et al.  Ebola RNA Persistence in Semen of Ebola Virus Disease Survivors  
Preliminary Report, N Engl J Med, October 2015; DIO:  10.1056/NEJMoas1511410.  
 
18.  Centers for Disease Control and Prevention, Possible Sexual Transmission of Ebola 
Virus  Liberia, 2015, Morbidity and Mortality Weekly, May 2015; 64(17):479-481. 
 
19.  Mate, S.E. et al.  Molecular Evidence of Sexual Transmission of Ebola Virus, N Engl J 
Med, October 2015; DIO:10.1056/NEJMoa1509773. 
 
20.  Leroy, E.M. et al., Human Asymptomatic Ebola Infection and Strong Inflammatory 
Response, The Lancet, 2000; 255: 2210-2215. 
 
21.  Nkoghe, D., Padilla, C., Becquart, P., et al., Risk Factors for Zaire Ebolavirus--Specific 
IgG in Rural Gabonese Populations, J Infect Dis, 2011; 204 Suppl 3:S768-775. 
 
22.  Maiztegui, J.I., Fernandez, N.J., de Damilano, A.J., Efficacy of Immune Plasma in 
Treatment of Argentine Haemorrhagic Fever and Association between Treatment and A 
Late Neurological Syndrome, The Lancet, 1979; 2:1216-1217. 
 
23.  Maruyama, T., Rodriguez, L.L., Jahrling, P.B., et al., Ebola Virus Can Be Effectively 
Neutralized by Antibody Produced in Natural Human Infection, J Virol, 1999; 73:6024-
6030. 
 
24.  Bradfute, S.B., Bavari, S., Correlates of Immunity to Filovirus Infection, Viruses, 2011; 
3:982-1000. 
 
25.  Qiu, X., Audet, J., Wong, G., et al., Successful Treatment of Ebola Virus-Infected 
Cynomolgus Macaques with Monoclonal Antibodies, Sci Transl Med, 2012; 4:138ra81. 
 
12  Contains Nonbinding Recommendations 
 
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