Lazarus Jeffrey V, Parkin Neil, Qureshi Huma, LaBrot Benjamin, Ward John W
CUNY Graduate School of Public Health and Health Policy, New York, New York, USA.
Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain.
Rev Med Virol. 2025 Sep;35(5):e70059. doi: 10.1002/rmv.70059.
Approximately 3.5 million people acquired HBV, HCV, or HIV-1 in 2022, and 340 million persons are infected with at least one of these three viruses, mostly in low- and middle-income countries (LMICs). Nucleic acid amplification tests (NAAT) are precise and sensitive tools for viral infection diagnosis, monitoring and sequencing. NAATs typically rely on plasma specimens, which can be challenging to collect, store and transport in LMICs, limiting the reach of NAAT testing in rural and other resource constrained settings where trained phlebotomists and/or a cold chain for preservation and shipping are not available. Alternative specimen types that can overcome this limitation include dried blood spots (DBS) and dried plasma prepared using the Cobas Plasma Separation Card (PSC). We performed a literature review of DBS and PSC use for NAAT of HBV, HCV, or HIV-1 to summarise their performance characteristics, relative advantages and disadvantages and potential to support expanded access to NAAT. DBS have been used extensively for HIV-1 diagnosis and viral load monitoring, as well as for HBV and HCV, albeit to a much lesser degree. Compared to plasma, DBS perform well in terms of accuracy but have lower sensitivity. There is a risk of low specificity due to the presence of cellular nucleic acids in DBS and a resulting over-estimation of viral load. The PSC has similar accuracy and sensitivity compared to DBS, but improved specificity due to the removal of cellular components. Both DBS and PSC have the potential to enhance access in populations where the use of plasma is challenging.
2022年，约有350万人感染了乙肝病毒（HBV）、丙肝病毒（HCV）或人类免疫缺陷病毒1型（HIV-1），3.4亿人感染了这三种病毒中的至少一种，其中大多数在低收入和中等收入国家（LMICs）。核酸扩增检测（NAAT）是用于病毒感染诊断、监测和测序的精确且灵敏的工具。NAAT通常依赖血浆样本，而在低收入和中等收入国家，采集、储存和运输血浆样本可能具有挑战性，这限制了NAAT检测在农村和其他资源有限地区的应用范围，因为这些地区可能没有经过培训的采血人员和/或用于保存和运输的冷链设备。能够克服这一限制的替代样本类型包括干血斑（DBS）和使用 cobas 血浆分离卡（PSC）制备的干血浆。我们对用于HBV、HCV或HIV-1的NAAT的DBS和PSC的使用进行了文献综述，以总结它们的性能特征、相对优缺点以及支持扩大NAAT检测可及性的潜力。DBS已广泛用于HIV-1诊断和病毒载量监测，也用于HBV和HCV检测，尽管程度要小得多。与血浆相比，DBS在准确性方面表现良好，但灵敏度较低。由于DBS中存在细胞核酸，存在特异性低的风险，从而导致病毒载量估计过高。与DBS相比，PSC具有相似的准确性和灵敏度，但由于去除了细胞成分，特异性有所提高。DBS和PSC都有潜力在使用血浆具有挑战性的人群中提高检测可及性。
