Q59-74: History of Infection at Any Time Prior to the Preparative Regimen

Specify documented infection(s) associated with HLH.

Question 59: Was an infection documented?

Indicate if an infection associated with HLH was present at any time prior to the start of the preparative regimen. If the recipient developed an infection associated with HLH prior to the start of the preparative regimen, select “yes” and continue with question 60. If there is no documentation of an infection associated with HLH, select “no” and continue with question 75.

Question 60: Cytomegalovirus (CMV):

Cytomegalovirus (CMV), also known as human herpesvirus 5 (HHV5), is one of the human herpes viruses (Herpesviridae family) and is very common, with an estimated 50-80% of individuals in the United States being 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.

If the recipient has a documented history of CMV associated with HLH, select “yes” and continue with question 61. If the recipient does not have a documented history of CMV, select “no” and continue with question 62.

Question 61: Specify the test method used for diagnosis of CMV:

Indicate the method used to diagnosis the CMV infection. The antigen method detects PP65 CMV proteins in leukocytes using an immunofluorescence assay. A PCR test is a molecular method to quantify the copies of CMV virus present in the sample. The shell vial test is performed by inoculating a culture within a shell vial with the specimen, incubating the culture, and staining to detect CMV. Indicate if the method used to diagnose CMV infection was “antigen,” “PCR,” or “shell vial test.”

Question 62: 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 and nasopharyngeal carcinoma.

If the recipient has a documented history of EBV associated with HLH, select “yes” and continue with question 63. If the recipient does not have a documented history of EBV, select “no” and continue with question 71.

Question 63: In situ hybridization:

In situ hybridization refers to the use of labeled viral probes to detect virus nucleic acids in tissue. Specify if the results of the in situ hybridization were “positive,” “negative,” or “not done” for EBV.

Question 64: Polymerase chain reaction (PCR):

Polymerase chain reaction (PCR) amplifies viral DNA to determine if the patient has a current primary infection or reactivated infection. Specify if the results of the PCR were “positive,” “negative,” or “not done” for EBV.

Question 65: Serology:

Serologic testing may be used to determine the presence of EBV antigen or antibodies to EBV. Specify if the results of the serology(s) were “positive,” “negative,” or “not done” for EBV. If “positive,” continue with question 66. If “negative” or “not done,” continue with question 70.

Questions 66-69: Specify titers:

Antibody titration to four EBV-specific markers can provide distinct information about whether a patient has a current primary or reactivated infection, recent infection, or past dormant infection. Antibodies to EBV nuclear antigen (EBNA) are not seen during acute infection, but develop 2-4 months after the first presentation of infection and persist for life. Early antigen testing measures IgG antibodies to early antigen; this generally appears at acute onset and is only detectable for 3-6 months. Viral capsid IgG measures IgG antibodies to viral capsid antigen that appear 2-4 weeks after presentation and persist for life. Viral capsid IgM testing for IgM antibodies to viral capsid antigen indicates current or recent infection, as it is generally only detectable for 4-6 weeks following first presentation.

Specify each EBV serologic antibody test as “positive” or “negative” in questions 66-69. Do not leave any response blank, unless testing failed, was inconclusive, or was not performed. If a validation error occurs due to the blank field, override the error.

Question 70: Was documentation submitted to the CIBMTR?

Indicate if a copy of the EBV results are attached. Use the Log of Appended Documents (Form 2800) to attach a copy of EBV result report(s). Attaching a copy of the report may prevent additional queries.

Question 71: Other infection:

Indicate if the recipient had an infection other than CMV or EBV associated with HLH at any time prior to the preparative regimen. If the recipient had an infection other than CMV or EBV, select “yes” and continue with question 72. If the recipient had no other documented infections associated with HLH, select “no” and continue with question 75.

Questions 72-74: Organism and Site:

For each infection, report the organism and site. Copy questions 72-74 for each infection.

72. Other Infection:
Specify the other viral, bacterial, fungal, or parasitic infection.

73. Organism:
From the list “Codes for Commonly Reported Organisms,” select the code corresponding to the identified or suspected organism as reported on the microbiology report, laboratory report, or other physician documentation. Report the code in the boxes provided. If the specific organism is not listed, use the “other, specify” code (198 – bacteria, 209 – Candida, 219 – Aspergillus, 259 – fungus, 329 – virus, 409 – parasite) and report the name of the organism in the space provided. If the source of the infection is not determined, use code 509.

74. Site:
From the list “Codes for Common Sites of Infection,” select the code corresponding to the site of the infection.

If three or more sites are infected with the same organism, enter code 2 (Disseminated – generalized, isolated at 3 or more distinct sites).

*Disseminated Infections
The CIBMTR acknowledges that a discrepancy exists between the CIBMTR definition (3 or more sites) and the BMT-CTN definition (2 or more sites) for disseminated infections. For the purposes of this form, please use “disseminated” when the same organism is isolated at three or more distinct sites.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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