Evaluation of Contamination Risk by the cobas e 602 Serology Module Before Viral Load Testing on the cobas 6800 System

التفاصيل البيبلوغرافية
العنوان: Evaluation of Contamination Risk by the cobas e 602 Serology Module Before Viral Load Testing on the cobas 6800 System
المؤلفون: Pedro L. Rodriguez, Julia Engstrom-Melnyk, Ed G. Marins, Stephen McCune, Leah Sakai
المصدر: Sexually transmitted diseases. 47(5S Suppl 1)
سنة النشر: 2020
مصطلحات موضوعية: Microbiology (medical), Time Factors, HIV Infections, Dermatology, Hepacivirus, Vial, Risk Assessment, Serology, Specimen Handling, Workflow, 03 medical and health sciences, 0302 clinical medicine, Medicine, Humans, Mass Screening, 030212 general & internal medicine, Screening instrument, Automation, Laboratory, 030505 public health, business.industry, Potential risk, Clinical Laboratory Techniques, Public Health, Environmental and Occupational Health, virus diseases, Contamination, Hepatitis B, Virology, Hepatitis C, Infectious Diseases, Molecular Diagnostic Techniques, Nucleic acid, Equipment Contamination, RNA, Viral, 0305 other medical science, business, Antibody screening, Viral load
الوصف: BACKGROUND Diagnosis of HCV, HBV, and HIV involves antibody screening followed by confirmation and/or treatment decision using nucleic acid tests. However, minimal data exist evaluating the risk of nucleic acid cross-contamination on serology devices upstream of molecular testing despite the potential clinical and laboratory workflow advantages of single specimen vial testing for both procedures. METHODS We conducted a checkerboard study investigating the potential risk of HCV, HBV, and HIV nucleic acid cross-contamination on 480 negative specimens by a serology screening instrument that uses disposable tips for sample transfer, rather than a fixed needle, before molecular testing. RESULTS Nucleic acid contamination was observed in 0 of 480 negative specimens when processed with alternating high-titer HCV, HBV, or HIV specimens on the serology platform. CONCLUSIONS This study suggests that specimens analyzed by a serology instrument using disposable tips for sample transfer may be suitable for direct primary specimen reflex testing by a sensitive nucleic acid confirmatory test.
تدمد: 1537-4521
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbde00be66e939bad6467177151e6a57
https://pubmed.ncbi.nlm.nih.gov/31895305
رقم الأكسشن: edsair.doi.dedup.....cbde00be66e939bad6467177151e6a57
قاعدة البيانات: OpenAIRE