Stem Cell Therapeutic Outcomes Database (Product Form)

CIBMTR.org

Forms Instruction Manual - 1

2004: Infectious Disease Markers
Form 2004 will come due in the following instances:
• Non-NMDP unrelated donor (TED or CRF track)
• Non-NMDP unrelated cord blood (TED or CRF track)
• Related cord blood (TED or CRF track)
• HLA-identical sibling (CRF track or when consented for “Research Sample Repository” on TED track)
• HLA-matched other relative or HLA-mismatched relative (CRF track or when consented for “Research
Sample Repository” on TED track)
If the donor or cord blood unit was secured through the NMDP, IDM test results will be reported by the
donor center on NMDP Forms 24 and 50, or will be submitted by the cord blood bank through CORD Link®.
Infectious diseases result from pathogens that enter the human body and multiply. Examples of pathogens
include viruses, bacteria, fungi, and parasites. Infectious diseases may be transmitted through liquids, food,
body fluids, contaminated objects, or airborne particles.
An Infectious Disease Marker (IDM) indicates if an individual currently has, or previously has had, an
infectious disease that could be transferred to another person.
• Antibody testing assesses whether an individual’s immune system recognizes an antigen
presentation, which indicates previous exposure to the pathogen.
• Antigen testing, such as testing for the presence of the Hepatitis B surface antigen, assesses whether
the individual has an active infection, where the pathogen is present in the blood. Antigen testing is
done because the individual may not yet have developed antibodies against the pathogen at the time
of infection.
The purpose of IDM testing is to assess the donor’s exposure to infectious diseases and the likelihood of
their transmitting a disease to the recipient.
For a glossary of terms used in this section of the manual, see Appendix B.

Page 214 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Q1-9: Donor/Cord Blood Unit Identification
Q10-46: Infectious Disease Markers
Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual
can be found below. For additional information, select the manual section and review the updated text.
If you need to reference the historical Manual Change History for this form, please click here or reference
the retired manual section on the Retired Forms Manuals webpage.

Date

Manual Section

Add/Remove/
Modify

Description

05/16/
2015

2004: Infectious
Disease Markers

Add

Added the following text to question 20:
“Non-U.S. centers should answer this question,
regardless of FDA licensure.”

Q1-9: Donor/Cord Blood Unit Identification
Question 1: Specify non-NMDP donor
Indicate whether the reported IDMs are for a related donor (peripheral blood stem cells or bone marrow), an
unrelated donor with product procured from a source other than the NMDP (peripheral blood stem cells or
bone marrow), or a non-NMDP cord blood unit (report related or autologous cord blood units as non-NMDP
cord blood units).
If the donor is related to the recipient, continue with question 4. If the donor is not related to the recipient
and the donation is not an NMDP product, continue with question 2. If the product is a cord blood unit
obtained from a non-NMDP bank, including related and autologous cord blood products, continue with
question 3.

Question 2: Non-NMDP unrelated donor ID
Specify the unrelated donor identification number used by the donor registry to identify and track the
[peripheral blood stem cell or bone marrow] donor. Continue with question 4.

Question 3: Non-NMDP cord blood unit ID
Specify the cord blood unit identification number used by the cord blood bank to identify and track the unit.
Continue with question 4.

Page 215 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Questions 4-5: Date of birth (donor/infant)
Indicate whether the donor’s or infant cord donor’s date of birth is “known” or “unknown.” If “known,” report
the donor’s or infant cord donor’s date of birth in question 5; if the date of birth is known, it is not necessary
to complete questions 6-7 specifying the donor or infant cord donor age. If “unknown,” continue with
question 6.

Questions 6-7: Age
Indicate whether the donor’s or infant cord donor’s age at the time of product collection is “known” or
“unknown.” If “known,” report the donor or infant cord donor’s age at the time of product collection in
question 7. If donor is less than one year old, report age in months rounded to the nearest whole month. If
the product was collected at birth, report “0” months. If “unknown,” continue with question 8.

Question 8: Sex (donor/infant)
Indicate the biological sex of the product donor or infant cord donor.

Question 9: Who is being tested for IDMs?
Indicate whether the donor (for peripheral blood stem cells and/or bone marrow products), mother of an
infant cord donor, or cord blood unit itself is being tested for IDMs. Maternal IDMs and cord blood unit IDMs
apply only to cord blood products; if both maternal and cord blood IDMs are available, report the results
from cord blood unit testing. Cord blood banks send documentation accompanying the cord that will specify
IDM results and the source of the specimen sent for IDM testing; most cord blood banks perform IDM testing
on maternal serum due to the limited volume and cell count of cord blood units.

Q10-46: Infectious Disease Markers
Report the final test results. Final test results could refer to either the initial screening test or the
confirmatory test. If a screening test is negative, a confirmatory test might not be done. In this case, use the
screening test as the final test result. However, if a screening test is positive, a confirmatory test may be
done. In this case, use the confirmatory test as the final test result.
When reporting inconclusive or indeterminate test results, leave the results data field blank in the
FormsNet application and override the error as “unknown.”

Hepatitis B Virus (HBV)

Page 216 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Hepatitis B infection is caused by the hepatitis B virus (HBV). Hepatitis B is spread through infected blood
and other body fluids. Signs and symptoms of infection generally occur 60-150 days after exposure and
include fever, fatigue, nausea, vomiting, and jaundice (secondary to liver inflammation). Patients with an
acute hepatitis B infection generally do not require treatment; approximately 95% of adults who get acute
hepatitis B will recover without developing chronic hepatitis B infection. Chronic hepatitis B infection is
generally monitored for progression or evidence of liver damage, at which point patients may be treated with
antiviral drugs. Chronic hepatitis B infection can lead to liver scarring (cirrhosis) and liver cancer
(hepatocellular carcinoma). In the United States, the hepatitis B vaccine is now part of the routine childhood
vaccination schedule.

Question 10: Hepatitis B surface antigen (HBsAg)
The hepatitis B surface antigen is a protein expressed on the surface of the hepatitis B virus. Its presence in
the blood serum indicates acute or active chronic infection. In acutely infected patients, blood will test
HBsAg positive within one to nine weeks of exposure to the virus. Patients who do not go on to develop
chronic infection will be surface antigen negative by 15 weeks after the onset of symptoms.
Chemiluminescent immunoassay (CIA), electrochemiluminescent immunoassay (ECLIA), or enzyme-linked
immunosorbent assay (ELISA) are used to test for the presence of hepatitis B surface antigens; research
indicates CIA and ECLIA may be more sensitive for detecting low levels of HBsAg. 1 Positive HBsAg results
require confirmation with specific antigen neutralization.
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
11.
If HBsAg testing was not done, indicate “not done” and continue with question 12.
1

Fei CR, Ye AQ, Zhang J. (2011). Evaluation of different methods in determination of low level HBsAg.
Zhejiang Da Xue Xue Bao Yi Xue Ban, 40(4):436-439.

Question 11: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Question 12: Hepatitis B core antibody (Anti-HBc)
The total hepatitis B core antibody refers to both IgG and IgM antibodies produced by the body in response
to the presentation of the core antigen by liver cells. Since core antigen is present only in infected liver cells
and cannot be detected in the blood of an infected individual, only core antibody is tested, since it circulates
in the peripheral blood. After infection, total core antibodies will persist for life. Presence of core antibodies
can indicate active and/or prior infection, but hepatitis core antibodies will not be present in individuals with

Page 217 of 1004

CIBMTR.org

Forms Instruction Manual - 1

no history of natural infection with HBV. This means that vaccinated individuals will not be anti-HBc positive
because vaccination results in the body developing antibodies to the hepatitis B surface antigen.
Chemiluminescent immunoassay (CIA), enzyme-linked immunosorbent assay (ELISA), or Elecsys anti-HBc
is used to test for the presence of hepatitis B core antibodies. Currently, there is no licensed confirmatory
test for anti-HBc in the United States; confirmation of antibody presence is done by performing a second
anti-HBc test using a different manufacturer’s test kit. 2
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
13.
If anti-HBc testing was not done, indicate “not done” and continue with question 14.
2

Centers for Disease Control & Prevention. (2012). CDC Hepatitis B Information for Health Professionals.
Retrieved from http://www.cdc.gov/hepatitis/HBV/HBVfaq.htm

Question 13: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Hepatitis C Virus (HCV)
Hepatitis C infection is caused by the hepatitis C virus (HCV). Hepatitis C is generally spread through
infected blood. Newly infected individuals are generally asymptomatic, though signs and symptoms of
infection, similar to those seen in other viral hepatitis infections, can develop. Since acute hepatitis C
infection is generally asymptomatic, it is rarely identified or treated during the acute infection stage.
Approximately 15-25% of infected individuals will clear the virus without treatment, and will not develop
chronic hepatitis C infection. Chronic hepatitis C infection can lead to chronic liver disease and/or scarring
of the liver (cirrhosis); chronic HCV is the leading indication for liver transplant in the United States.
Currently no approved vaccination for hepatitis C exists.

Question 14: Hepatitis C antibody (Anti-HCV)
The total hepatitis C antibody refers to both IgG and IgM antibodies produced by the body in response to the
presentation of antigens by the hepatitis C virus. Antibodies can generally be detected as soon as four
weeks after exposure and will persist for life. Enzyme-linked immunosorbent assay (ELISA) or
chemiluminescent immunoassay (CIA) is used to screen for hepatitis C antibodies; confirmatory testing is
done by recombinant immunoblot assay (RIBA). A positive ELISA or CIA result without confirmation by RIBA
is considered an indeterminate result, unless HCV RNA is detected in the blood by PCR.

Page 218 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
15.
If anti-HCV testing was not done, indicate “not done” and continue with question 16.

Question 15: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Human T-Lymphotropic Virus (Anti-HTLV I/II)
Human T-lymphotropic viruses include two distinct and separate retroviruses, HTLV-1 and HTLV-2. In 2005
two additional HTLV virus types (HTLV-3 and HTLV-4) were discovered and found to be closely related to
the two originally known lymphotropic viruses. The mechanism of transmission of HTLV-1 and HTLV-2 is
somewhat uncertain, but believed to be through exposure to blood or other body fluids, or through vertical
transmission (maternal-fetal transmission). Patients infected with HTLV-1 or HTLV-2 are generally
asymptomatic, and there is currently no treatment or vaccine. Infection with HTLV-1 is associated with an
increased risk of T-cell leukemia/lymphoma. Patients with HTLV-1 or HTLV-2 are also at risk for HTLVassociated myelopathy, also known as tropical spastic paraparesis, a progressive and permanent disease of
the central nervous system.

Question 16: Human T-Lymphotropic Virus antibody (Anti-HTLV I/II)
Testing for antibodies to HTLV is typically done by enzyme-linked immunosorbent assay (ELISA) or
chemiluminescent immunoassay (CIA). The immunoassays are typically combined and will detect antibodies
to HTLV-1 and HTLV-2. There is no way to determine if a positive result is due to antibodies to HTLV-1,
HTLV-2, or both. Currently, there is no licensed confirmatory test for anti-HTLV I/II in the United States;
confirmation of antibody presence is done by performing a second anti-HTLV I/II test using a different
manufacturer’s test kit.
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
17.
If anti-HTLV I/II testing was not done, indicate “not done” and continue with question 18.

Question 17: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Human Immunodeficiency Virus (HIV)

Page 219 of 1004

CIBMTR.org

Forms Instruction Manual - 1

HIV infection is caused by exposure to one of two viruses, either HIV-1 or HIV-2. HIV-2 is less virulent and
has a longer incubation period than HIV-1. Both types of HIV progressively destroy CD4+ cells, which
include T-helper cells, monocytes, and their derivatives (macrophages and dendritic cells), and are an
important part of the body’s immune defense. HIV can lead to acquired immunodeficiency syndrome (AIDS),
a condition in which the immune system begins to fail, leading to life-threatening opportunistic infections.
Mechanism of HIV transmission is through exposure to blood or other body fluids, or through vertical
transmission (maternal-fetal transmission).

Question 18: Human Immunodeficiency Virus p24 antigen (HIV-1 p24 antigen)
The HIV p24 antigen is a viral core protein that is detectable in the blood during acute infection; it is
detectable earlier than HIV antibody. The p24 antigen appears approximately two weeks after exposure and
will be present in the blood for three to five months. Once antibodies to HIV are detectable in the blood, p24
antigen is usually no longer detectable by immunoassay due to antigen-antibody binding. Enzyme-linked
immunosorbent assay (ELISA) is used to test for the presence of p24 antigen; it may be done in conjunction
with antibody testing in order to detect the virus in all stages of infection. Positive p24 antigen results
require confirmation with specific antigen neutralization. 3
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
19.
If HIV-1 p24 antigen testing was not done, indicate “not done” and continue with question 20.
If HIV-1 p24 testing was performed but results are not being reported to CIBMTR (for example, donor
declines to release results), indicate “not reported” and continue with question 20.
3

University of California, San Francisco. (n.d.) HIV InSite Knowledge Base. Retrieved January 15, 2013,
from http://hivinsite.ucsf.edu/InSite?page=KB

Question 19: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Question 20: Was FDA licensed NAT testing for HIV-1/HCV performed?
Nucleic acid testing (NAT) is a combination PCR test that detects the presence of viral genes rather than
antigens or antibodies. This test allows earlier detection and provides more sensitivity than previously used
tests.
If the test results include HBV NAT testing or if a non-FDA licensed NAT test was used, report these results
under question 43, Other Infectious Disease Marker.

Page 220 of 1004

CIBMTR.org

Forms Instruction Manual - 1

If FDA-licensed NAT testing was used to assess the patient for presence of HIV-1 and/or HCV RNA, check
“yes” and continue with question 21. If no FDA-licensed NAT testing was used to assess the patient for
presence of HIV-1 or HCV RNA, check “no” and continue with question 25.
Non-U.S. centers should answer this question, regardless of FDA licensure.

Question 21: Human Immunodeficiency Virus-1 (HIV-1) NAT
Report the laboratory result as “positive” or “negative,” and continue with question 22.
If HIV-1 NAT testing was performed but results are not being reported to CIBMTR (for example, donor
declines to release results), indicate “not reported” and continue with question 23.

Question 22: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Question 23: Hepatitis C (HCV) NAT
Report the laboratory result as “positive” or “negative,” and continue with question 24.

Question 24: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Question 25: Anti-HIV 1 and anti-HIV 2
The HIV-1 and HIV-2 antibodies are produced by the body in response to the antigens presented by the
HIV-1 and HIV-2 viruses, such as p24 (HIV-1) core antigen and p26 (HIV-2) core antigen. Antibodies are not
detectable as early during the course of infection as the viral antigens, but will persist for the patient’s
lifetime once developed. Enzyme-linked immunosorbent assay (ELISA) is used to test for the presence of
HIV-1 and HIV-2 antibodies. Most laboratories will utilize a combined assay that detects both viral
antibodies, but in some cases they will be done as separate tests. Positive HIV-1 antibody results require
confirmation by western blot, which uses gel electrophoresis to detect specific proteins. Currently, there is
no licensed confirmatory test for anti HIV-2 in the United States; confirmation of antibody presence is done
by performing a second anti HIV-2 test using a different manufacturer’s test kit.
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative) only if the patient was
evaluated for antibodies to both HIV-1 and HIV-2. Continue with question 26.
If the patient was only assessed for antibodies to one virus, report “not done” and continue with question 27.

Page 221 of 1004

CIBMTR.org

Forms Instruction Manual - 1

If no anti HIV-1 and anti HIV-2 testing was done, indicate “not done” and continue with question 27.
If anti HIV-1 and anti HIV-2 testing was performed but results are not being reported to CIBMTR (for
example, donor declines to release results), indicate “not reported,” and continue with question 27.

Question 26: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Syphilis
Syphilis is a bacterial disease that spreads by contact with open syphilis sores that generally occur on the
external genitalia and anus. It can also be spread through transmission from mother to fetus, also known as
“vertical transmission.” It is caused by Treponema pallidum bacterium and can be treated with antibiotics; in
the early stages of disease, syphilis is generally curable. Late stage syphilis—generally untreated or
resistant disease—can cause permanent damage to internal organs or lead to neurosyphilis, where the
bacterium invades the central nervous system.

Question 27: Serologic test for syphilis (STS)
Serologic testing for syphilis includes several testing methods which are either nontreponemal or
treponemal. Examples of nontreponemal testing are Venereal Disease Research Laboratory (VDRL) and
rapid plasma reagin (RPR) testing. Nontreponemal testing includes any evaluation done to detect
antiphospholipid antibodies that are created by the body in response to syphilis infection; however, these
antibodies are not specific for Treponema pallidum, and may also be created as response to HIV, malaria,
pneumonia, or Lyme disease. Confirmatory testing must be done with treponemal methods for any positive
result. Treponemal testing utilizes Treponema pallidum or its components to test for antibodies specific to
syphilis infection. Treponemal testing includes fluorescent treponemal antibody absorption (FTA-ABS),
microhemagglutination assay for antibodies to Treponema pallidum (MHA-TP), and Treponema pallidum
hemagglutination assay (TPHA).
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
28.
If STS testing was not done, indicate “not done” and continue with question 29.

Question 28: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Page 222 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Cytomegalovirus (CMV)
Cytomegalovirus (CMV), also known as human herpes virus 5 (HHV5), is one of the Herpesviridae family
and is very common. It is estimated that 50-80% of people in the United States are infected by age 40. In
healthy individuals, infection with CMV may not lead to any symptoms; however, the virus will lay dormant in
the body after initial infection and can reoccur. In immunocompromised patients, such as
immunosuppressed transplant recipients or HIV/AIDS patients, the virus can have serious consequences
such as pneumonia, liver failure, and death.

Question 29: Cytomegalovirus antibody (Anti-CMV) (IgG or Total)
Testing for antibodies to CMV is typically done by enzyme-linked immunosorbent assay (ELISA) or latex
agglutination testing. These test methods can be used to detect IgM and/or IgG, which are both antibodies
to CMV. The presence of IgM antibodies indicates a recent or current infection, usually within the past six
months. The presence of IgG antibodies indicates a previous infection and confers a long-term immune
response to the virus. All other factors being equal, CMV-negative products are generally preferred for
CMV-naïve recipients. Results may be expressed as quantified antibody titer. In this case, the laboratory or
test kit manufacturer will provide reference ranges to determine if the result is considered positive,
indeterminate, or negative.4
Report the laboratory result as “reactive” (positive) or “non-reactive” (negative), and continue with question
30. A positive IgM or IgG assay is considered a “positive” or “reactive” result. Any previous history of
positive antibody assay can be reported as a “positive” or “reactive” test result, even if the donor was not
retested. All CMV testing on cord blood units should be reported as “non-reactive.” If IDM testing for a cord
blood unit was done on maternal serum, report the documented testing result.
If anti-CMV testing was not done, indicate “not done” and continue with question 31.
4

Centers for Disease Control & Prevention. (2012). CDC CMV Homepage. Retrieved from
http://www.cdc.gov/cmv/index.html

Question 30: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

West Nile Virus (WNV)
West Nile Virus (WNV) is part of the Flaviviridae family and can infect birds, humans, and other mammals. It
is spread by exposure to infected blood, most commonly through a mosquito vector. It can also be spread
through transmission from mother to fetus (also known as “vertical transmission”), blood transfusions, organ

Page 223 of 1004

CIBMTR.org

Forms Instruction Manual - 1

transplant, or needlesticks. Mild or moderate symptoms of WNV may include fever, tiredness, headache and
body aches, skin rash, and swollen lymph nodes. Severe symptoms of WNV include encephalitis, myelitis,
and meningitis.

Question 31: West Nile Virus NAT (WNV-NAT)
Nucleic acid testing (NAT) is a PCR test that detects the presence of viral genes (WNV RNA) rather than
antigens or antibodies. This test allows earlier detection and is more sensitive than antibody testing.
Report the laboratory result as “positive” or “negative,” and continue with question 32. Do not report WNV
enzyme-linked immunosorbent assay (ELISA) testing results; report this or any other WNV or anti-WNV
testing under “Other Infectious Disease Marker” in questions 43-46.
If WNV-NAT testing was not done, indicate “not done” and continue with question 33. Do not use the “not
applicable” option; “not done” is the most appropriate response for all situations in which WNV-NAT testing
was not done.

Question 32: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Chagas (T. cruzi)
Chagas disease is caused by the parasitic protozoan Trypanosoma cruzi (T. cruzi), which is endemic in
South America, Central America, and the Caribbean. Chagas is spread through exposure to infected blood,
most commonly through an insect vector such as triatomine bugs. It can also be spread through
transmission from mother to fetus (also known as “vertical transmission”), blood transfusions, organ
transplant, or needlesticks. In acute infection, there are rarely severe symptoms; most cases are
asymptomatic or will exhibit generalized, non-specific symptoms. Treatment with anti-parasitic drugs during
the acute phase is often curative. Of the individuals who are untreated and enter the chronic phase of
infection, only 20-40% will ever have signs and symptoms related to Chagas disease. Symptomatic Chagas
disease can affect the nervous, digestive, and cardiac systems and can be very severe, even resulting in
death.

Question 33: Chagas
Testing for antibodies to T. cruzi is generally done by enzyme-linked immunosorbent assay (ELISA) or
chemiluminescent immunoassay (CIA). If active infection is suspected, another evaluation, such as PCR,
may be done to confirm and identify the strain of infection. In 2011, the FDA approved a more specific
immunoassay that evaluates the donor for antibodies to specific excreted-secreted antigens presented by

Page 224 of 1004

CIBMTR.org

Forms Instruction Manual - 1

the T. cruzi pathogen. This assessment is intended to be a supplemental test for individuals who have been
repeatedly reactive to the previously approved immunoassays.
Report the laboratory result as “positive” or “negative,” and continue with question 34.
If Chagas testing was not done, indicate “not done” and continue with question 35.

Question 34: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Herpes Simplex Virus (HSV)
Herpes Simplex Virus includes two viruses, HSV-1 and HSV-2, which are two of the human herpes viruses
(Herpesviridae family). Other human herpes viruses include cytomegalovirus (CMV), Epstein-Barr virus
(EBV), and varicella zoster virus (VZV). HSV-1 is typically manifested as skin lesions or lesions of the oral
mucous membranes; it may also infect the genitalia, but this is less common. HSV-2 is typically manifested
as lesions of the external genitalia. Both HSV-1 and HSV-2 are spread through contact with lesions during
active infection; HSV-1 can be spread through saliva. After initial infection, the virus will lay dormant in the
body and can reoccur. Stress, fatigue, and infection can all cause the virus to be reactivated. According to
data from 1999-2004, the seroprevalence of HSV-1 in individuals in the United States between ages 14-49
is estimated at 57.7%, while the seroprevalence of HSV-2 for the same population is estimated at 17.2%. 5
5

Xu F, Sternberg MR, Kottiri BJ, et al. (2006). Trends in Herpes Simplex Virus Type 1 and 2
Seroprevalence in the United States. J Am Med Assoc, 296(8).

Question 35: Herpes simplex virus antibody (Anti-HSV)
Testing for antibodies to HSV is typically done by enzyme-linked immunosorbent assay (ELISA),
glycoprotein G-specific immunoblot assay, or Western Blot. These immunoassays detect antibodies to both
HSV-1 and HSV-2, though the results will specify whether detected antibodies are specific to HSV-1 or
HSV-2 (or both). Results may be expressed as quantified antibody titer; in this case, the laboratory or test
kit manufacturer will provide reference ranges to determine if the result is considered positive,
indeterminate, or negative.
Report the laboratory result as “positive” or “negative,” and continue with question 36. If either HSV-1 or
HSV-2 antibodies are detected, report “positive.”
If anti-HSV testing was not done, indicate “not done” and continue with question 37.

Page 225 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Question 36: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Epstein-Barr Virus (EBV)
Epstein-Barr Virus (EBV) is one of the human herpes viruses (Herpesviridae family). EBV infection may
cause infectious mononucleosis, particularly in young adults. Infectious mononucleosis symptoms include
fever, sore throat, lymphadenopathy, and fatigue. After initial infection, the virus will lay dormant in the body
and can reoccur; recurrence of EBV is often subclinical. Late events associated with prior EBV infection
include Burkitt’s lymphoma, post-transplant lymphoproliferative disorder (PTLD), and nasopharyngeal
carcinoma.

Question 37: Epstein-Barr virus antibody (Anti-EBV)
Testing for antibodies to EBV is typically done by enzyme-linked immunosorbent assay (ELISA). This
immunoassay can be used to detect IgM and/or IgG antibodies to EBV. The presence of IgM antibodies
indicates a recent or current infection, usually within the past four to six months. Presence of IgG antibodies
indicates a previous infection and confers long-term immune response to the virus. Results may be
expressed as quantified antibody titer; in this case, the laboratory or test kit manufacturer will provide
reference ranges to determine if the result is considered positive, indeterminate, or negative.
Report the laboratory result as “positive,” “negative,” or “inconclusive,” and continue with question 38.
If anti-EBV testing was not done, indicate “not done” and continue with question 39.

Question 38: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Varicella Zoster Virus (VZV)
Varicella zoster virus (VZV) is one of the human herpes viruses (Herpesviridae family). VZV, known as
chickenpox with its initial presentation, manifests as pruritic skin blisters and typically first presents in
childhood. After the initial infection, the virus will lay dormant in the body and can reoccur. Recurrence
results in herpes zoster, more commonly known as shingles, which manifests as a painful, blistering skin
rash.

Question 39: Varicella zoster virus antibody (Anti-VZV)

Page 226 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Testing for antibodies to VZV is generally done by fluorescent-antibody-to-membrane-antigen (FAMA),
enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay (CIA). These
immunoassays can be used to detect IgM and/or IgG antibodies to VZV. Presence of IgM antibodies
indicates a recent or current infection, usually within the past four to six months. Presence of IgG antibodies
indicates a previous infection and confers a long-term immune response to the virus. Results may be
expressed as quantified antibody titer; in this case, the laboratory or test kit manufacturer will provide
reference ranges to determine if the result is considered positive, indeterminate, or negative.
Report the laboratory result as “positive” or “negative,” and continue with question 40.
If anti-VZV testing was not done, indicate “not done” and continue with question 41.

Question 40: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Toxoplasmosis
Toxoplasmosis is caused by the parasitic protozoan Toxoplasma gondii, or T. gondii. Toxoplasmosis is
spread through ingestion of contaminated food or water, or contact with infected cat feces. T. gondii
infection is usually subclinical in healthy individuals, but infection can cause serious symptoms in pregnant
women and immunocompromised individuals. Chronic, dormant T. gondii infection may follow initial
exposure, and can then reoccur. Severe toxoplasmosis can affect the brain, eyes, and other organs and can
cause permanent organ damage.

Question 41: Toxoplasmosis
Testing for antibodies to T. gondii is generally done by enzyme-linked immunosorbent assay (ELISA) or
chemiluminescent immunoassay (CIA). These immunoassays can be used to detect IgM and/or IgG
antibodies to T. gondii. The presence of IgM antibodies indicates a recent or current infection, usually within
the past four to six months. The presence of IgG antibodies indicates a previous infection and confers a
long-term immune response to the virus. Results may be expressed as quantified antibody titer; in this case,
the laboratory or test kit manufacturer will provide reference ranges to determine if the result is considered
positive, indeterminate, or negative. Confirmatory testing is available to verify a positive serological result;
this is done by Toxoplasma Serological Profile (TSP), which is a panel of multiple antibody ELISAs and
agglutination testing.
Report the laboratory result as “positive” or “negative,” and continue with question 42.
If Toxoplasmosis testing was not done, indicate “not done” and continue with question 43.

Page 227 of 1004

CIBMTR.org

Forms Instruction Manual - 1

Question 42: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Other Infectious Disease Marker
Testing may be done for antibodies to pathogens other than those already listed on this form. If the donor
was tested for any other infectious disease markers, report in questions 43-46. Questions 44-46 can be
duplicated to report multiple additional IDM results.
Examples of other testing that may be reported as an “other infectious disease marker” include:
• Anti-HBs
• Anti-HBe
• WNV by ELISA
• Lyme disease

Question 43: Other infectious disease marker
Indicate if the donor was tested for an IDM other than those already listed on this form; do not report PCR
results. If the donor was tested for other IDMs, check “yes” and continue with question 44. If the donor was
not tested for any other IDMs, check “no” and continue with signature section.

Question 44: Date sample collected
Indicate the date the sample was collected for infectious disease marker testing.

Question 45: Specify test and method
Specify the pathogen(s) evaluated, the immunoassay or other test used, and the immunoglobulins
measured.

Question 46: Specify test results
Report the qualitative laboratory results of the IDM (ex: reactive/non-reactive); do not report quantified titer
levels.

Page 228 of 1004