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How safe is safe: new human immunodeficiency virus Type 1 variants missed by nucleic acid testing
Author(s) -
Müller Benjamin,
Nübling C. Micha,
Kress Julia,
Roth W. Kurt,
De Zolt Silke,
Pichl Lutz
Publication year - 2013
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.12298
Subject(s) - nat , virology , primer (cosmetics) , nucleic acid , window period , biology , human immunodeficiency virus (hiv) , nucleic acid amplification tests , virus , nucleic acid test , blood donor , viral load , microbiology and biotechnology , antibody , genetics , medicine , serology , immunology , chemistry , covid-19 , computer network , disease , organic chemistry , pathology , chlamydia trachomatis , computer science , infectious disease (medical specialty)
Background Nucleic acid amplification techniques ( NAT ) in routine blood donor screening considerably reduce the diagnostic window phase period. Nevertheless, several reports of false‐negative NAT results were published. Here, four cases of human immunodeficiency virus Type 1 ( HIV ‐1) RNA –positive blood donations that escaped detection by NAT screening are described. Study Design and Methods A total of 2.7 million blood donations were screened for viral infections between J anuary 2010 and O ctober 2012 in our G erman R ed C ross blood donation service. Four plasma specimens with false‐negative NAT results were comparatively investigated with 12 CE ‐marked NAT assays. In two cases of putative HIV ‐1 variants the target region of the NAT assay was sequenced allowing comparison with the respective primers and probes. Results Most of the NAT assays used in routine blood donor screening with the 5′‐long terminal repeat ( LTR ) as target region demonstrated deficiencies in detecting the viral variants and the low‐viral‐carrier donations. Sequence analysis revealed in one case a deletion of 56 nucleotides within the 5′‐ LTR preventing the binding of the probe accompanied by a neighbored insertion of another 52 nucleotides and several primer mismatches in another case. No false‐negative results were obtained for these cases using dual‐target assays. The viral load of the remaining two false‐negative results was below the NAT 's limit of detection. Conclusion HIV ‐1 is characterized by a high mutation rate and rapid generation of new viral variants. By the use of one target region for HIV ‐1 NAT assays there is a certain risk of false‐negative results. Employing HIV ‐1 multi‐ and dual‐target assays in routine blood donor screening seems to be a reasonable possibility to minimize this problem.