检测常规获得的血清标本中的轮状病毒抗原血症，以增强监测和疫苗效果评估。

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Pediatr Infect Dis J. 2010 Sep;29(9):836-9. doi: 10.1097/INF.0b013e3181e753d1.

BACKGROUND

: Antigenemia is common among children with rotavirus disease. Because obtaining stool specimens is cumbersome, we evaluated whether detection of antigenemia in sera obtained during routine clinical practice could augment rotavirus surveillance to assess the effect of vaccination.

METHODS

: We determined the sensitivity, specificity, and positive and negative predictive values of serum/plasma rotavirus antigen detection using fecal antigen positivity as the gold standard. Fecal specimens obtained by active surveillance and residual serum/plasma specimens obtained during routine clinical testing from children 15 days to 23 months of age presenting with acute gastroenteritis (AGE) to a children's hospital in Houston were tested for rotavirus using a commercially available enzyme immunoassay. Using case-control methods, we compared vaccine effectiveness (VE) using cases identified through serum/plasma testing versus stool testing.

RESULTS

: Of the 205 AGE patients with fecal specimens, 71 (35%) had a serum/plasma sample available. Among these 71 children, antigenemia was detected in 22 of 29 with rotavirus-positive fecal specimens (sensitivity = 75%; 95% confidence interval [CI] = 60%-91%) versus 2 of 42 children with rotavirus-negative fecal specimens (specificity = 95%; 95% CI = 89%-100%). The positive and negative predictive values of rotavirus antigenemia were 92% (95% CI = 81%-100%) and 85% (95% CI = 75%-95%), respectively. Thirty-four of 195 children with AGE without fecal specimens had serum/plasma available; 10 (29%) had rotavirus antigenemia. Three-dose VE using cases identified through serum/plasma testing was similar (VE = 84%; 95% CI = 25%-96%) to that using cases identified though fecal testing (VE = 85%; 95% CI = 55%-95%).

CONCLUSIONS

: Detection of antigenemia in routinely collected serum/plasma could augment identification of rotavirus disease for postlicensure evaluation of impact and effectiveness of rotavirus vaccination.

背景

抗原血症在轮状病毒病患儿中很常见。由于获取粪便标本很麻烦，我们评估了在常规临床实践中检测血清中的抗原是否可以增强轮状病毒监测，以评估疫苗接种的效果。

方法

我们确定了使用粪便抗原阳性作为金标准时血清/血浆轮状病毒抗原检测的敏感性、特异性、阳性和阴性预测值。从休斯顿一家儿童医院急性胃肠炎（AGE）就诊的 15 至 23 个月龄儿童中，通过主动监测获得粪便标本，并从常规临床检测中获得剩余的血清/血浆标本，使用商业上可用的酶免疫测定法检测轮状病毒。使用病例对照方法，我们比较了通过血清/血浆检测与粪便检测确定病例的疫苗有效性（VE）。

结果

在 205 名有粪便标本的 AGE 患者中，有 71 名（35%）有血清/血浆样本可用。在这 71 名儿童中，29 名轮状病毒粪便标本阳性的儿童中有 22 名（敏感性=75%；95%置信区间[CI]：60%-91%）和 42 名轮状病毒粪便标本阴性的儿童中有 2 名（特异性=95%；95% CI：89%-100%）检测到抗原血症。轮状病毒抗原血症的阳性和阴性预测值分别为 92%（95% CI：81%-100%）和 85%（95% CI：75%-95%）。在 195 名没有粪便标本的 AGE 儿童中，有 34 名有血清/血浆样本可用；其中 10 名（29%）有轮状病毒抗原血症。使用血清/血浆检测确定病例的三剂 VE 相似（VE=84%；95% CI：25%-96%），使用粪便检测确定病例的 VE 也相似（VE=85%；95% CI：55%-95%）。