Chagas Disease Serological Test Performance in US Blood Donor Specimens
Chagas Disease Serological Test Performance in US Blood Donor Specimens
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DOI：
10.1128/jcm.01217-19
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发表时间：
2019-12-01
影响因子：
9.4
通讯作者：
Bern, Caryn
中科院分区：
文献类型：
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作者：
Whitman, Jeffrey D.;Bulman, Christina A.;Bern, Caryn
查加斯病在美国估计影响30万人。慢性期的诊断需要两种不同IgG血清学试验的阳性结果。三种酶联免疫吸附试验（ELISA）（Hemagen、Ortho和Wiener）和一种快速检测（InBios）获得FDA批准，但在美国人群中的比较数据很少。我们评估了500例血清阳性和300例血清阴性献血者血浆样本。已知255份血清阳性标本的出生国，这些标本分为以下地区：墨西哥（n = 94）、中美洲（n = 88）和南美洲（n = 73）。通过四种FDA批准的IgG血清学检测试剂盒对标本进行检测。通过两个比较器和潜在类分析来评估测试性能。InBios的敏感性最高（97.4%至99.3%），但特异性最低（87.5%至92.3%）。Hemagen的敏感性最低（88.0%~ 92.0%），但特异性较高（99.0%~ 100.0%）。Ortho（92.4%-96.5%）和Wiener（94.0%-97.1%）的灵敏度水平居中;两者均具有高特异性（分别为98.8%-100.0%和96.7%-99.3%）。来自墨西哥的供体的抗体反应性和临床敏感性水平最低，来自中美洲的供体居中，来自南美洲的供体最高。我们的研究结果提供了一个初步的证据基础，以提高实验室诊断恰加斯病在美国。目前最好的测试算法将采用高灵敏度筛选测试，然后进行高特异性验证测试。
Chagas disease affects an estimated 300,000 individuals in the United States. Diagnosis in the chronic phase requires positive results from two different IgG serological tests. Three enzyme-linked immunosorbent assays (ELISAs) (Hemagen, Ortho, and Wiener) and one rapid test (InBios) are FDA cleared, but comparative data in U.S. populations are sparse. We evaluated 500 seropositive and 300 seronegative blood donor plasma samples. Country of birth was known for 255 seropositive specimens, which were grouped into regions as follows: Mexico (n = 94), Central America (n = 88), and South America (n = 73). Specimens were tested by the four FDA-cleared IgG serological assays. Test performance was evaluated by two comparators and latent class analysis. InBios had the highest sensitivity (97.4% to 99.3%) but the lowest specificity (87.5% to 92.3%). Hemagen had the lowest sensitivity (88.0% to 92.0%) but high specificity (99.0% to 100.0%). The level of sensitivity was intermediate for Ortho (92.4% to 96.5%) and Wiener (94.0% to 97.1%); both had high specificity (98.8% to 100.0% and 96.7% to 99.3%, respectively). The levels of antibody reactivity and clinical sensitivity were lowest in donors from Mexico, intermediate in those from Central America, and highest in those from South America. Our findings provide an initial evidence base to improve laboratory diagnosis of Chagas disease in the United States. The best current testing algorithm would employ a high-sensitivity screening test followed by a high-specificity confirmatory test.