Question 35: Did the recipient have a history of clinically significant fungal infection (documented or suspected) in the 6 months prior to the start of the preparative regimen?

Fungal infections play a major role in the clinical outcome of a transplant recipient. The intent of this question is to identify serious fungal infection(s) that might have an effect on the outcome of the HCT. For the purposes of this manual, the term “clinically significant” refers to conditions that are treated at the time of pre-HCT evaluation, or that have affected the recipient’s medical history, that might cause complications post-HCT.

Examples of fungal infections include, but are not limited to the following: invasive aspergillosis (infection codes 210-213, 219), zygomycosis (infection code 240) and other molds (infection codes 230, 240, 242, 261), invasive candidiasis (infection codes 200-209), cryptococcosis (infection code 220), endemic mycosis (infection code 241), other yeasts (infection code 250), and pneumocystsis (PCP/PJP) (infection code 260). Include any fungal abscesses of the lungs, sinuses, liver, or spleen.

If the recipient has a history of clinically significant fungal infection in the 6 months prior to this HCT event, check “yes” and continue with question 36. For a subsequent HCT, report any documented significant fungal infections in the recipient’s medical history, between the start of the preparative regimen of the previous HCT to just prior to the preparative regimen for the current HCT.

If the recipient does not have a history of clinically significant fungal infection in the 6 months prior to this HCT event, check “no” and continue with question 38. For assistance with reporting fungal infections, consult with a transplant physician.

Question 36: Select organism:

From the list of “Codes for Commonly Reported Fungal Organisms,” select the code corresponding to the identified or suspected fungus. A fungal infection form (Form 2046) must be completed for all organisms.

Question 37: Date of diagnosis

Enter the date of diagnosis of the fungal infection. For suspected fungal infections, enter the date of a radiology test or date treatment was started as the date of diagnosis.

Fungal Infection Diagnosis Reporting Scenario
p((. A recipient has a CT scan on 4/1/2015 due to a persistent cough. The CT scan documents multiple nodules. An Aspergillus galactomannan was drawn in the blood on 4/2/2015 and the patient underwent a bronchoscopy on 4/3/2015. Fluid from the bronchoaveolar lavage was stained for fungal elements and submitted for culture. The stain was positive for fungal elements and the culture grew Aspergillus The blood galactomannan was also positive.
p((. * The date of diagnosis of infection will be 4/2/2015. This is the date the galactomannan was obtained and positive.
p((. * If galactomannan was negative and the BAL negative, the date of infection would be 4/1/2015 (the date of the CT scan).

Question 38: Testing for evidence of prior viral exposure/infection: (check all that apply)

Indicate if the recipient was positive for any of the viral exposure or infections listed below. Do not select the viral exposure or infection if the test was performed and the results were negative.

If testing for evidence of prior viral exposure / infection was not performed, select “not done.”

Select “not applicable” if testing for evidence of prior viral exposure / infection was performed and all of the results were negative.

HTLV1 antibody: Human T-Lymphotropic virus I/II (HTLV I/II) is a retrovirus in the same class as HIV. HTLV I/II is associated with certain leukemias and lymphomas, as well as demyelinating diseases such as multiple sclerosis.

Anti-EBV (Epstein-Barr virus antibody): Epstein-Barr Virus (EBV) is a common virus of the herpes family. It can cause infectious mononucleosis, but in most cases is asymptomatic. EBV establishes a lifelong dormant infection in some cells of the body’s immune system. Serious post-transplant complications related to EBV include EBV viremia (reactivation) and post-transplant lymphoproliferative disease (PTLD).

Hepatitis B surface antibody: Hepatitis B is caused by the hepatitis B virus (HBV). Infection with this virus can cause scarring of the liver, liver failure, liver cancer, and even death. Hepatitis B is spread through infected blood and other body fluids. Acute hepatitis B infection does not usually require treatment because most adults clear the infection. Treatment of chronic infection may be necessary to reduce the risk of cirrhosis and liver cancer.

The hepatitis B surface antibody test reveals the presence of hepatitis B antibodies, indicating previous exposure to HBV (or successful vaccination), but the virus is no longer present, and the person cannot pass on the virus.

A Hepatitis insert (Form 2047) is not required for a positive result.

Anti-HBc (hepatitis B core antibody): The enzyme-linked immunosorbent assay (ELISA) technique tests for the antibody directed against the hepatitis B virus core proteins. The hepatitis B core antibody test can indicate previous HBV infection. Currently there is no licensed confirmatory test for Anti-HBc. If the screening test is reactive, a second Anti-HBc test is performed using a different manufacturer’s test kit.

If the result is “positive,” a Hepatitis insert (Form 2047) is also required.

HBsAg (hepatitis B surface antigen): The ELISA or enzyme immunoassay (EIA) techniques test for the presence of proteins produced by the hepatitis B virus. Confirmatory testing is done using a neutralization test. The first marker appears approximately three weeks following infection, and disappears approximately six months later.

If the result is “positive,” a Hepatitis insert (Form 2047) is also required.

Hepatitis B – NAAT: The HBV NAAT test is more sensitive than regular serologic tests and is often used in conjunction with those tests to monitor patients with chronic HBV infections. If Hepatitis B – NAAT testing was done, report the results in this section.

If the result is “positive,” a Hepatitis insert (Form 2047) is also required.

Anti-HCV (hepatitis C antibody): Hepatitis C is a serious infection caused by the hepatitis C virus (HCV), which attacks the liver and may cause life-long infection. HCV is considered the most serious hepatitis infection because of its significant long-term health consequences. The infection is often asymptomatic, but once established, chronic infection can cause inflammation of the liver. This condition can progress to fibrosis and cirrhosis. In some cases, those with cirrhosis will go on to develop liver failure or liver cancer. Presence of the antibody in the blood represents exposure to HCV, which is most often spread by blood-to-blood contact. No vaccine against HCV is available.

The ELISA technique tests for antibodies to the HCV. Confirmatory testing is done using the recombinant immunoblot assay (RIBA) test. These tests can determine past exposure to HCV, but not current viral load.

If the result is “positive,” a Hepatitis insert (Form 2047) is also required.

Hepatitis C – NAAT: Nucleic acid testing (NAAT) is a combination PCR test that detects the presence of viral genes (HCV RNA) rather than antigens or antibodies. This test allows earlier detection and provides more sensitivity than previously used tests.

If the result is “positive,” a Hepatitis insert (Form 2047) is also required.

HIV antibody: HIV infection is caused by exposure to one of two viruses: 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 lymphocytes, which 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. Infection with HIV occurs by the transfer of bodily fluids and is present as both free virus particles and virus within infected immune cells.

HIV antibody testing is done using combination ELISA which detects antibodies to the HIV-1 and HIV-2 viruses. HIV-1 is confirmed by Western Blot, which detects specific proteins using gel electrophoresis. There is currently no licensed confirmatory test for HIV-2. If the screening test is reactive, HIV-2 is confirmed by specific ELISA.

The results of HIV assessments are often kept in confidence and may not be reportable to anyone other than the patient and their physician. If HIV testing was done, but the results are not available, do not select this option.

If the result is “positive,” an HIV insert (Form 2048) is also required.

HIVNAAT: Nucleic acid testing (NAAT) is a 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.

The results of HIV assessments are often kept in confidence and may not be reportable to anyone other than the patient and their physician. If HIV testing was done, but the results are not available, do not select this option.

If the result is “positive,” an HIV insert (Form 2048) is also required.

Toxoplasmosis antibody: 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.

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.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
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Last modified: Dec 22, 2020

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