Evaluation of an in-house HIV-1 drug resistance genotypic testing for using dried blood spot specimens in China. 2015

Hai Zhao, and Lingjie Liao, and Hui Xing, and Zhe Wang, and Bin Su, and Jia Liu, and JianJun Wu, and Yi Feng, and Cui He, and Yuhua Ruan, and Yiming Shao

OBJECTIVE We evaluated an In-house assay for HIV-1 drug resistance genotyping by using DBS samples in China. METHODS The amplification sensitivity was assessed using 79 DBS specimens with plasma viral load ranging from 1,000 to 6,000 copies/ml. Precision was assessed using 5 DBS specimens with 5 replicates tested in one test run. Reproducibility was evaluated using other 5 DBS specimens with 5 replicates genotyped in 5 test runs. Nucleotide sequence identity and the degree of concordance in detecting drug resistance mutations were assessed within and between test runs. In addition, nucleotide sequence and drug resistance mutations were compared between 64 matched plasma and DBS specimens. RESULTS The amplification rate of DBS specimens with plasma viral load of 1,000-6,000 copies/ml was 96.2% (76/79). The nucleotide sequence identity was 99.7±0.34% and 99.6±0.25% within and between test runs, respectively. Moreover, there was a near perfect agreement of detecting drug resistance mutations intra- and inter- test runs with kappa value of 0.972 and 0.963, respectively. Between 64 pairs of plasma and DBS specimens, the nucleotide identity was excellent with 99.5±0.34%. As compared to the results of plasma specimens, the sensitivity and specificity for detecting drug resistance mutations in DBS specimens were 99.4 % (95% CI, 97.4-99.8%) and 99.8% (95% CI, 99.7-99.9%), respectively. Totally 15 discordant drug resistance mutations were found. Among them, 53.3 % (8/15) were caused by mixture base. CONCLUSIONS The In-house HIVDR genotyping assay could be used for testing DBS samples with viral load above 1,000 copies/ml in China and had a low intra- and inter- assay variability. DBS is an excellent alternative to plasma for HIV-1 drug resistance genotyping at population levels in China.

UI MeSH Term Description Entries
D008297 Male Males
D008826 Microbial Sensitivity Tests Any tests that demonstrate the relative efficacy of different chemotherapeutic agents against specific microorganisms (i.e., bacteria, fungi, viruses). Bacterial Sensitivity Tests,Drug Sensitivity Assay, Microbial,Minimum Inhibitory Concentration,Antibacterial Susceptibility Breakpoint Determination,Antibiogram,Antimicrobial Susceptibility Breakpoint Determination,Bacterial Sensitivity Test,Breakpoint Determination, Antibacterial Susceptibility,Breakpoint Determination, Antimicrobial Susceptibility,Fungal Drug Sensitivity Tests,Fungus Drug Sensitivity Tests,Sensitivity Test, Bacterial,Sensitivity Tests, Bacterial,Test, Bacterial Sensitivity,Tests, Bacterial Sensitivity,Viral Drug Sensitivity Tests,Virus Drug Sensitivity Tests,Antibiograms,Concentration, Minimum Inhibitory,Concentrations, Minimum Inhibitory,Inhibitory Concentration, Minimum,Inhibitory Concentrations, Minimum,Microbial Sensitivity Test,Minimum Inhibitory Concentrations,Sensitivity Test, Microbial,Sensitivity Tests, Microbial,Test, Microbial Sensitivity,Tests, Microbial Sensitivity
D002681 China A country spanning from central Asia to the Pacific Ocean. Inner Mongolia,Manchuria,People's Republic of China,Sinkiang,Mainland China
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001483 Base Sequence The sequence of PURINES and PYRIMIDINES in nucleic acids and polynucleotides. It is also called nucleotide sequence. DNA Sequence,Nucleotide Sequence,RNA Sequence,DNA Sequences,Base Sequences,Nucleotide Sequences,RNA Sequences,Sequence, Base,Sequence, DNA,Sequence, Nucleotide,Sequence, RNA,Sequences, Base,Sequences, DNA,Sequences, Nucleotide,Sequences, RNA
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D015497 HIV-1 The type species of LENTIVIRUS and the etiologic agent of AIDS. It is characterized by its cytopathic effect and affinity for the T4-lymphocyte. Human immunodeficiency virus 1,HIV-I,Human Immunodeficiency Virus Type 1,Immunodeficiency Virus Type 1, Human

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