False-positive results for human immunodeficiency virus type 1 nucleic acid amplification testing in chimeric antigen receptor T cell therapy Journal Article


Authors: Hauser, J. R.; Hong, H.; Babady, N. E.; Papanicolaou, G. A.; Tang, Y. W.
Article Title: False-positive results for human immunodeficiency virus type 1 nucleic acid amplification testing in chimeric antigen receptor T cell therapy
Abstract: Chimeric antigen receptor (CAR) T cell immunotherapy has been a major advancement in cancer therapeutics. Reprogramming of T cells is achieved by using gammaretroviral or lentiviral vectors, which may interfere with human immunodeficiency virus type 1 (HIV-1) nucleic acid amplification testing (NAAT). Here, we describe three clinical scenarios in which CAR T cell immunotherapy interfered with HIV-1 testing, including (i) routine infectious disease screening prior to stem cell transplantation in a 16-year-old female with B cell acute lymphoblastic leukemia, post CAR T cell treatment; (ii) routine infectious disease screening prior to second CAR T cell collection in a 65-year-old male with diffuse large B cell lymphoma who failed initial CAR T cell treatment; and (iii) routine infectious risk assessment following an occupational health exposure from a 58-year-old male with multiple myeloma, who received CAR T cell treatment. In each case, patients initially tested negative by the “fourth-generation” HIV-1 screening enzyme immunoassay (targeting the p24 antigen and anti-HIV-1 antibodies), but positive by the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test v2.0 (targeting gag and the long terminal repeat [LTR]). These samples subsequently retested negative using the Abbott m2000 RealTime HIV-1 assay, which targets the integrase gene. These results indicated that cross-reactions between lentiviral vectors and LTR genomes targeted in the HIV-1 NAAT caused the HIV-1 NAAT false-positive results. © 2019 American Society for Microbiology. All Rights Reserved.
Keywords: adolescent; adult; clinical article; aged; middle aged; case report; cancer growth; multiple myeloma; stem cell transplantation; acute lymphoblastic leukemia; cause of death; cancer regression; hla matching; health care personnel; chimeric antigen receptor; hospital admission; immunoassay; erythrocyte; virus load; cross reaction; bone marrow transplantation; false positive result; body fluid; hiv; human immunodeficiency virus 1; disease transmission; hiv-1; b cell leukemia; occupational exposure; human immunodeficiency virus 1 infection; limit of detection; virus antibody; diffuse large b cell lymphoma; nucleic acid amplification; human; male; female; priority journal; article; chimeric antigen receptor t-cell immunotherapy; car t cell therapy; sibling donor
Journal Title: Journal of Clinical Microbiology
Volume: 58
Issue: 1
ISSN: 0095-1137
Publisher: American Society for Microbiology  
Date Published: 2020-01-01
Start Page: e01420-19
Language: English
DOI: 10.1128/jcm.01420-19
PUBMED: 31694968
PROVIDER: scopus
PMCID: PMC6935905
DOI/URL:
Notes: Source: Scopus
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MSK Authors
  1. Ngolela Esther Babady
    174 Babady
  2. Yi-Wei Tang
    188 Tang
  3. Hong Hong
    7 Hong
  4. Jocelyn Renee Hauser
    6 Hauser