Development of a new dipstick (Cholkit) for rapid detection of Vibrio cholerae O1 in acute watery diarrheal stools.
Development of a new dipstick (Cholkit) for rapid detection of Vibrio cholerae O1 in acute watery diarrheal stools.
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DOI：
10.1371/journal.pntd.0006286
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发表时间：
2018-03
影响因子：
3.8
通讯作者：
Qadri F
中科院分区：
文献类型：
--
作者：
Sayeed MA;Islam K;Hossain M;Akter NJ;Alam MN;Sultana N;Khanam F;Kelly M;Charles RC;Kováč P;Xu P;Andrews JR;Calderwood SB;Amin J;Ryan ET;Qadri F
早期识别霍乱病例，特别是在暴发的初始阶段和霍乱以前没有传播过的地区，是一个高度优先的公共卫生事项。在这种情况下，实验室的能力往往有限。为了解决这一问题，我们开发了一种称为Cholkit的快速诊断测试（RDT），该测试基于免疫色谱侧流检测，用于使用粪便诊断霍乱病例。Cholkit含有针对霍乱弧菌O 1脂多糖的O-特异性多糖（OSP）组分的单克隆抗体（ICL-33），可识别Inaba和Ogawa血清型。我们在孟加拉国达卡的icddr，B医院使用76名患有急性水样腹泻的成人和儿童的新鲜粪便标本测试了Cholkit试纸。我们将Cholkit的性能与微生物培养、PCR（靶向霍乱弧菌的rfb和ctxA基因）和市售RDT、Crystal VC（Span Diagnostics;苏拉特，印度）的性能进行了比较。我们发现，所有粪便标本培养阳性的霍乱弧菌O 1（n = 19）是阳性的Cholkit以及晶体VC。然后，我们使用贝叶斯潜在类建模来估计每个诊断测定的灵敏度和特异性。Cholkit、微生物培养、PCR和Crystal VC的敏感性分别为98%（95% CI：88-100）、71%（95% CI：59-81）、74%（95% CI：59-86）和98%（95% CI：88-100）。对O 1型霍乱弧菌的特异性分别为97%（95% CI：89-100）、100%、97%（95% CI：93-99）和98%（95% CI：92-100）。值得注意的是，两个Crystal VC试纸对霍乱弧菌O 139呈阳性，但在该地区的培养和PCR结果为阴性，而该地区没有已知的流行性霍乱弧菌O 139。总之，Cholkit试纸使用简单，不需要专门的实验室能力，对霍乱弧菌O 1的灵敏度和特异性分别为98%和97%。Cholkit值得在其他环境中进一步评估。霍乱是一种严重的脱水性肠道疾病，如果不治疗可能导致死亡。在暴发初期，病死率较高。在霍乱爆发的早期阶段进行诊断是一项高度优先的公共卫生工作。虽然面临复杂紧急情况的国家更容易受到霍乱爆发的影响，但在这种情况下的实验室能力通常有限。为了解决这个问题，在这里，我们报告了一个快速诊断测试（RDT）称为Cholkit霍乱病例的诊断使用粪便和评估其性能与微生物培养，PCR和晶体VC检测，市售的试纸使用潜在的类建模方法。
Recognizing cholera cases early, especially in the initial phase of an outbreak and in areas where cholera has not previously circulated, is a high public health priority. Laboratory capacity in such settings is often limited. To address this, we have developed a rapid diagnostic test (RDT) termed Cholkit that is based on an immunochromatographic lateral flow assay for the diagnosis of cholera cases using stool. Cholkit contains a monoclonal antibody (ICL-33) to the O-specific polysaccharide (OSP) component of V. cholerae O1 lipopolysaccharide, and recognizes both Inaba and Ogawa serotypes. We tested the Cholkit dipstick using fresh stool specimens of 76 adults and children presenting with acute watery diarrhea at the icddr,b hospital in Dhaka, Bangladesh. We compared Cholkit’s performance with those of microbial culture, PCR (targeting the rfb and ctxA genes of V. cholerae) and the commercially available RDT, Crystal VC (Span Diagnostics; Surat, India). We found that all stool specimens with a positive culture for V. cholerae O1 (n = 19) were positive by Cholkit as well as Crystal VC. We then used Bayesian latent class modeling to estimate the sensitivity and specificity of each diagnostic assay. The sensitivity of Cholkit, microbiological culture, PCR and Crystal VC was 98% (95% CI: 88–100), 71% (95% CI: 59–81), 74% (95% CI: 59–86) and 98% (95% CI: 88–100), respectively. The specificity for V. cholerae O1 was 97% (95% CI: 89–100), 100%, 97% (95% CI: 93–99) and 98% (95% CI: 92–100), respectively. Of note, two Crystal VC dipsticks were positive for V. cholerae O139 but negative by culture and PCR in this area without known circulating epidemic V. cholerae O139. In conclusion, the Cholkit dipstick is simple to use, requires no dedicated laboratory capacity, and has a sensitivity and specificity for V. cholerae O1 of 98% and 97%, respectively. Cholkit warrants further evaluation in other settings. Cholera is a severely dehydrating diarrheal disease that can lead to death if remains untreated. The incidence of case fatality is higher at the beginning of the outbreak. Diagnosis of cholera in the early stage of outbreak is a high public health priority. Although countries facing complex emergencies are more vulnerable to cholera outbreak, laboratory capacity in such settings is usually limited. To address this, here we report the development of a rapid diagnostic test (RDT) termed Cholkit for the diagnosis of cholera cases using stool and the assessment of its performance with those of microbial culture, PCR and Crystal VC assay, a commercially available dipstick using a latent class modeling approach.
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影响因子：
3.3
作者：
George, Christine M.;Rashid, Mahamud-ur;Alam, Munirul
通讯作者：
Alam, Munirul
影响因子：
9.4
作者：
Bhuiyan, NA;Qadri, F;Nair, GB
通讯作者：
Nair, GB
影响因子：
168.9
作者：
Harris, Jason B.;LaRocque, Regina C.;Calderwood, Stephen B.
通讯作者：
Calderwood, Stephen B.
DOI：
10.1128/cdli.1.1.51-54.1994
发表时间：
1994-01-01
期刊：
CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY
影响因子：
--
作者：
QADRI, F;AZIM, T;ALBERT, MJ
通讯作者：
ALBERT, MJ
影响因子：
3.3
作者：
Kalluri, P;Naheed, A;Mintz, ED
通讯作者：
Mintz, ED