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中华妇幼临床医学杂志(电子版)

Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition) ›› 2021, Vol. 17 ›› Issue (06): 699 -708. doi: 10.3877/cma.j.issn.1673-5250.2021.06.012

Original Article

Values of serum presepsin (sCD14-ST) in diagnosis of neonatal sepsis: a Meta-analysis

Qiao Lin, Hua Wang†()   

  • Received:2021-07-16 Revised:2021-10-10 Published:2021-12-01
  • Corresponding author: Hua Wang
  • Supported by:
    Applied Basic Research Project of Science and Technology Department of Sichuan Province(2021YJ0171)
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Objective

To explore diagnostic values of serum soluble CD14 subtype (sCD14-ST, presepsin) in neonatal sepsis (NS) by Meta-analysis.

Methods

Prospective or retrospective case-control studies literature on diagnostic value of serum presepsin in NS in English databases such as PubMed and Web of Science, as well as Chinese databases such as CNKI and Wanfang database were searched by computer and Cochrane system evaluation method. Literature retrieval time was set from January 1990 to September 2020. According to retrieval strategies set in this study, researchers searched and screened literature and extracted data, and evaluated quality of literature by Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2), and then used Meta-Disc 1.4 and Stata 14.0 software for Meta-analysis. The main outcome indicators of serum presepsin in diagnosis of NS were combined sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR), summary receiver operating characteristics (SROC) curve and area under curve (AUC). Threshold effect was evaluated by distribution characteristics of SROC curve and Spearman correlation coefficient between sensitivity logarithm and (1-specificity) logarithm of serum presepsin in diagnosis of NS. Heterogeneity between studies was analyzed by Cochrane-Q test, and the source of heterogeneity was further explored by subgroup analysis. Publication bias was analyzed by Deek′s funnel plot.

Results

A total of 15 pieces of literature were finally included, and results of study on value of serum presepsin in diagnosis of NS were as follows. ①A total of 1 394 newborns from 6 countries were included with 812 cases of NS children in study group and 582 cases of non-NS children in control group. ②The 15 pieces of literature met the criteria of diagnostic accuracy quality evaluation of QUADAS-2 with acceptable bias risk and applicable NS diagnostic standard. ③Results of SROC curve of serum presepsin in diagnosis of NS in 15 pieces of included literature showed that SROC curve did not show a typical " shoulder-arm" distribution, and Spearman correlation coefficient between sensitivity logarithm and (1-specificity) logarithm of serum presepsin in diagnosis of NS was -0.020 (P=0.945), indicating that there was no threshold effect among 15 pieces of literature. The sensitivity, specificity, PLR, NLR and DOR value of serum presepsin in diagnosis of NS were highly heterogeneous (I2=81.0%, 75.8%, 67.2%, 76.3%, 68.7%; all P<0.001), suggesting that there was heterogeneity caused by non-threshold effect among 15 pieces of literature. So, random effect model was used for Meta-analysis. Combined sensitivity of serum presepsin in diagnosis of NS was 89% (95%CI: 87%-91%, P<0.001), combined specificity was 90% (95%CI: 88%-93%, P<0.001), combined PLR was 8.39 (95%CI: 5.18-13.60, P<0.001), combined NLR was 0.13 (95%CI: 0.09-0.21, P<0.001), and combined DOR value was 98.83 (95%CI: 43.21-226.07, P<0.001), SROC-AUC was 0.96 (95%CI: 0.95-0.98). Subgroup analysis showed that non-threshold effect heterogeneity among literature may be caused by serum presepsin detection method [enzyme-linked immunosorbent assay (ELISA) method: PLR of serum presepsin in diagnosis of NS was 12.10 (6.31-23.17), I2=42.9%, P=0.105, DOR value was 270.76 (84.62-866.32), I2=40.5%, P=0.121; chemiluminescence enzyme immunoassay (CLEIA) method: PLR was 5.80 (3.27-10.28), I2=65.9%, P=0.005, DOR value was 45.47 (17.5-118.15), I2=69.0%, P=0.002]. ④Deek′s funnel plot showed that 15 pieces of literature were basically symmetrically distributed on 2 sides of the regression line, and the difference was not statistically significant (P=0.640).

Conclusions

Diagnostic value of serum presepsin in NS is relatively high in 15 pieces of literature, and detection of serum presepsin by ELISA is more accurate and reliable in diagnosis of NS. Limited by the subjects and quality of included literature, the above conclusions need to be confirmed by more high-quality studies.

Key words: Sepsis, Neonatal sepsis, Presepsin, Soluble CD14 subtype, Meta-analysis, Diagnostic tests, routine, Infant, newborn
表1 本研究纳入文献的基本信息与血清presepsin检测方法及其NS诊断结果
文献编号(No.) NS患儿例数(例) 研究设计类型 检测方法 真阳性(例) 假阳性(例) 假阴性(例) 真阴性(例) 敏感度(%) 特异度(%)
研究组 对照组
1 30 30 前瞻性 ELISA 27 4 3 26 88.9 85.7
2 26 29 前瞻性 ELISA 23 3 3 26 88.9 88.9
3 30 30 回顾性 ELISA 30 4 0 26 100.0 86.7
4 31 20 回顾性 ELISA 30 1 1 19 96.8 95.0
5 41 41 回顾性 ELISA 40 2 1 39 97.6 95.1
6 32 38 前瞻性 CLEIA 30 0 2 38 93.0 100.0
7 49 21 前瞻性 CLEIA 42 6 7 15 85.2 72.2
8 40 15 回顾性 CLEIA 38 2 2 13 95.7 87.5
9 29 40 前瞻性 CLEIA 23 10 6 30 80.0 75.0
10 102 66 回顾性 ELISA 84 0 18 66 82.4 100.0
11 80 40 前瞻性 ELISA 80 1 0 39 100.0 97.5
12 42 40 前瞻性 CLEIA 28 0 14 40 67.0 100.0
13 192 106 前瞻性 CLEIA 180 16 12 90 93.8 84.9
14 42 30 回顾性 CLEIA 31 6 11 24 74.4 80.0
15 46 36 回顾性 CLEIA 36 1 10 35 78.3 97.2
图1 文献筛选流程及结果
图2 纳入研究文献的偏倚风险及适应性评估结果注：文献No.1~15依次为纳入研究文献[15]~[29]
图3 纳入15篇文献血清presepsin检测诊断NS的SROC曲线注：NS为新生儿败血症。SROC曲线为汇总受试者工作特征曲线
图4 纳入15篇文献血清presepsin检测诊断NS的敏感度的Meta分析注：文献No.1~15依次为纳入研究文献[15]~[29]。NS为新生儿败血症
图5 纳入15篇文献血清presepsin检测诊断NS的特异度的Meta分析注：文献No.1~15依次为纳入研究文献[15]~[29]。NS为新生儿败血症
图6 纳入15篇文献血清presepsin检测诊断NS的PLR的Meta分析注：文献No.1~15依次为纳入研究文献[15]~[29]。NS为新生儿败血症，PLR为阳性似然比
图7 纳入15篇文献血清presepsin检测诊断NS的NLR的Meta分析注：文献No.1~15依次为纳入研究文献[15]~[29]。NS为新生儿败血症，NLR为阴性似然比
图8 纳入15篇文献血清presepsin检测诊断NS的DOR的Meta分析注：文献No.1~15依次为纳入研究文献[15]~[29]。NS为新生儿败血症，DOR为诊断比值比
表2 纳入15篇文献血清presepsin检测诊断NS的亚组分析结果
组别 文献篇数(篇) 敏感度(%，95%CI) 敏感度异质性检验[I2值(%)/P值] 特异度(%，95%CI) 特异度异质性检验[I2值(%)/P值] PLR(95%CI) PLR异质性检验[I2值(%)/P值]
文献年份              
  2018年及以后 8 86(82~90) 74.7/<0.001 93(89~95) 65.0/0.006 9.90(5.09~19.26) 57.8/0.020
  2018年前 7 91(88~93) 85.9/<0.001 88(84~92) 82.8/<0.001 7.14(3.49~14.64) 73.4/0.001
受试儿所在国家              
  非洲 8 92(89~95) 79.8/<0.001 92(88~95) 71.1/0.001 10.07(4.71~21.54) 68.3/0.002
  亚、欧州 7 86(82~89) 80.7/<0.001 89(85~92) 80.9/<0.001 7.09(3.67~13.70) 67.6/0.005
血清presepsin诊断NS的临界值(pg/mL)              
  800 6 87(82~91) 75.6/0.001 90(85~94) 68.8/0.007 7.69(3.75~15.75) 57.0/0.040
  <800 9 90(87~92) 84.6/<0.001 90(87~93) 80.9/<0.001 9.45(4.71~18.96) 74.5/<0.001
研究设计类型              
  前瞻性 8 90(87~93) 83.2/<0.001 88(85~92) 80.0/<0.001 6.97(3.81~12.75) 69.3/0.002
  回顾性 7 87(83~90) 80.2/<0.001 93(89~96) 68.2/0.004 11.15(4.83~25.77) 64.0/0.010
血清presepsin检测方法              
  ELISA 7 92(89~95) 81.4/<0.001 94(91~97) 58.7/0.024 12.10(6.31~23.17) 42.9/0.105
  CLEIA 8 86(83~89) 79.6/<0.001 87(83~91) 80.3/<0.001 5.80(3.27~10.28) 65.9/0.005
组别 文献篇数(篇) NLR(95%CI) NLR异质性检验[I2值(%)/P值] DOR(95%CI) DOR异质性检验[I2值(%)/P值]
文献年份          
  2018年及以后 8 0.14(0.08~0.25) 65.6/0.005 122.10(36.26~411.13) 65.3/0.005
  2018年前 7 0.12(0.06~0.27) 84.5/<0.001 85.59(24.35~300.89) 75.2/<0.001
受试儿所在国家          
  非洲 8 0.07(0.03~0.16) 70.8/0.001 210.43(52.87~837.54) 67.9/0.003
  亚、欧州 7 0.19(0.11~0.32) 79.4/<0.001 51.97(18.46~146.26) 69.0/0.004
血清presepsin诊断NS的临界值(pg/mL)          
  800 6 0.13(0.06~0.28) 74.5/0.001 74.37(25.25~219.08) 50.4/0.073
  <800 9 0.13(0.07~0.23) 78.5/<0.001 130.36(37.75~450.18) 76.9/<0.001
研究设计类型          
  前瞻性 8 0.13(0.07~0.26) 80.7/<0.001 70.22(24.77~199.06) 70.3/0.001
  回顾性 7 0.13(0.07~0.24) 73.2/0.001 168.30(36.71~771.49) 70.6/0.002
血清presepsin检测方法          
  ELISA 7 0.07(0.03~0.17) 70.4/0.002 270.76(84.62~866.32) 40.5/0.121
  CLEIA 8 0.18(0.11~0.30) 78.0/<0.001 45.47(17.5~118.15) 69.0/0.002
图9 本研究纳入15篇文献发表偏倚Deek′s漏斗图注：DOR为诊断比值比。n为文献纳入样本量
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