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.

尽早识别霍乱病例，尤其是在疫情爆发的初期以及以前未传播霍乱的地区，是公共卫生的高度优先事项。在这种情况下，实验室的能力通常是有限的。为了解决这个问题，我们开发了一种称为Cholkit的快速诊断测试（RDT），该测试基于免疫层析侧向流动测定法，用于通过粪便诊断霍乱病例。Cholkit包含针对V的O特异性多糖（OSP）成分的单克隆抗体（ICL-33）。霍乱O1脂多糖，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名成人和患急性水样腹泻的新鲜大便标本对Cholkit量油尺进行了测试。我们比较Cholkit与这些微生物培养，PCR（瞄准的性能RFB和CTXA基因V，霍乱）和市售RDT，水晶VC（跨度诊断;苏拉特，印度）。我们发现所有粪便标本对V呈阳性培养。霍乱Cholkit和Crystal VC的O1（n = 19）均为阳性。然后，我们使用贝叶斯潜伏类建模来估计每种诊断测定的敏感性和特异性。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）。V的特异性。霍乱O1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量油尺对V呈阳性。霍乱弧菌O139，但在这方面没有已知的流行性循环通过培养和PCR阴性V。霍乱O139。总之，Cholkit量油尺易于使用，不需要专门的实验室能力，并且对V具有敏感性和特异性。霍乱O1分别为98％和97％。Cholkit保证在其他环境中进行进一步评估。