新兴的蜱传疾病,如无性体病,babesiosis,或者埃里希体病,是由具有临床相当表现的专性细胞内病原体引起的。当今实验室中使用的诊断方法是血清学测定和血液涂片分析,有已知的诊断极限。本研究评估了实验室开发的用于多重定性检测无性体的样品-答案直接实时PCR测试的性能,巴贝西亚,和全血样本中的埃里希菌DNA.与两种标准护理(SOC)方法相比,DiaSorintick传实验室开发的无胞浆检测试验表明,阳性百分比一致性(PPA)和阴性百分比一致性(NPA)为100%(95%CI,0.80至1.0)和89%(95%CI,0.74至0.97),分别与显微镜检查的不一致率为9.3%。在不和谐的决议之后,NPA增加到100%。对于Babesia来说,试验显示PPA为100%(95%CI,0.90~1.0),NPA为100%(95%CI,0.90~1.0).与SOCPCR方法相比,血浆样品显示PPA为100%(95%CI,0.66至1.0)和NPA为100%(95%CI,0.90至1.0)。埃里希体结果显示PPA为100%(95%CI,0.69至1.0),NPA为100%(95%CI,0.90至1.0)。与SOC方法相比,总的百分比一致性为98%(95%CI,0.95至0.99),κ统计值为0.95(95%CI,0.90至0.99)或几乎完美的一致性。这个实验室开发的检测无等离子体的测试,巴贝西亚,和埃里希菌DNA提供了无需核酸提取的蜱传感染的快速和可靠的检测。
目的:这项工作表明,对蜱传疾病的检测,如无性体病,babesiosis,或者埃里希体病,可以直接从全血进行,没有提取。这里描述的测定与现有方法具有高的阳性和阴性百分比一致性,并且用作护理标准。蜱传疾病的发病率不断增加,加上缺乏训练有素的技术人员来进行传统的手动测试,可适应各种实验室设置的测试选项,是最重要的。
Emerging tick-borne illnesses, such as anaplasmosis, babesiosis, or ehrlichiosis, are caused by obligate intracellular pathogens that have clinically comparable presentations. Diagnostics used in laboratories today are serologic assays and blood smear analyses, which have known diagnostic limits. This study evaluated the performance of a sample-to-answer direct real-time PCR laboratory-developed test for the multiplex qualitative detection of Anaplasma, Babesia, and
Ehrlichia DNA in whole-blood specimens. Compared to two standard-of-care (SOC) methods, the DiaSorin tick-borne laboratory-developed test for Anaplasma detection demonstrated a positive percent agreement (PPA) and negative percent agreement (NPA) of 100% (95% CI, 0.80 to 1.0) and 89% (95% CI, 0.74 to 0.97), respectively with a discordant rate of 9.3% against microscopy. After discordant resolution, the NPA increased to 100%. For Babesia, the test demonstrated a PPA of 100% (95% CI, 0.90 to 1.0) and NPA of 100% (95% CI, 0.90 to 1.0). Compared to a SOC PCR method Anaplasma samples showed a PPA of 100% (95% CI, 0.66 to 1.0) and NPA of 100% (95% CI, 0.90 to 1.0).
Ehrlichia results showed a PPA of 100% (95% CI, 0.69 to 1.0) and NPA of 100% (95% CI, 0.90 to 1.0). The total percent agreement was 98% (95% CI, 0.95 to 0.99) with a κ statistic of 0.95 (95% CI, 0.90 to 0.99) or almost perfect agreement compared to SOC methods. This laboratory-developed test for detecting Anaplasma, Babesia, and
Ehrlichia DNA provides rapid and reliable detection of tick-borne infections without nucleic acid extraction.
OBJECTIVE: This work demonstrates that detection of tick-borne illnesses, such as anaplasmosis, babesiosis, or ehrlichiosis, can be performed directly from whole blood with no extraction. The assay described here has a high positive and negative percent agreement with existing methods and is used as the standard of care. An increasing incidence of tick-borne illness combined with shortage of well-trained technologists to perform traditional manual testing, testing options that can be adapted to various lab settings, are of the utmost importance.