Acharya Rohan, Gathwala Geeta, Sharma Madhu
Pediatrics, All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar, IND.
Neonatology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, IND.
Cureus. 2025 May 3;17(5):e83436. doi: 10.7759/cureus.83436. eCollection 2025 May.
Background Neonatal sepsis is a major cause of mortality in low- and middle-income countries (LMICs) such as India, where delayed diagnosis and antimicrobial resistance (AMR) challenge effective management. Conventional blood cultures, taking 2-5 days for pathogen identification, delay targeted therapy, worsening outcomes, and fueling AMR. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) (bioMérieux, USA) offers rapid diagnostics, potentially transforming neonatal sepsis care. This study assesses the diagnostic speed of MALDI-TOF MS versus conventional methods in neonates with suspected sepsis at a North Indian tertiary hospital, alongside bacteriological and AMR profiling. Methodology From November 2022 to November 2023, we prospectively enrolled 100 consecutive outborn neonates (<28 days) with suspected sepsis (positive sepsis screen: ≥2 parameters, e.g., C-reactive protein, leukocyte count) at a tertiary care hospital. Neonates with prior antibiotics, severe asphyxia, or malformations were excluded. Blood samples underwent BacT/Alert culture, with pathogens identified by conventional methods (2-5 days) and MALDI-TOF MS (VITEK MS, bioMérieux, USA). Time-to-identification was compared (paired t-test, p < 0.05). Antimicrobial susceptibility testing used VITEK-2 (bioMérieux, USA) per Clinical and Laboratory Standards Institute guidelines, with chi-square tests analyzing microbiological and AMR data. Results Among 100 neonates (50 early-onset sepsis (EOS), mean age = 1.34 ± 0.692 days; 50 late-onset sepsis (LOS), mean age = 14.418 ± 9.395 days), MALDI-TOF MS identified pathogens in 1.47 ± 0.979 days (median = 2 days) versus 2.83 ± 0.817 days (median = 3 days) for conventional culture (p = 0.0052), a 48% reduction. (35%) and (28%) predominated EOS, while LOS included (30%), (30%), and (10%, LOS-only). Gram-negative isolates showed >85% susceptibility to meropenem and ertapenem; amikacin and colistin were effective, though had reduced amikacin sensitivity (60%). Beta-lactams were poorly effective (<40%). Gram-positive isolates were sensitive to linezolid and vancomycin (>90%), except spp. (0% vancomycin susceptibility). Conclusions MALDI-TOF MS accelerates neonatal sepsis diagnosis by 1.36 days, enabling earlier targeted therapy. Coupled with dominant pathogens (, ) and rising AMR (e.g., vancomycin-resistant ), it highlights the need for rapid diagnostics in LMICs. Carbapenems remain viable empirical options, but resistance trends demand stewardship. This study supports integrating MALDI-TOF MS into neonatal care, enhancing outcomes and informing antibiotic policies.
新生儿败血症是印度等低收入和中等收入国家（LMICs）儿童死亡的主要原因，在这些国家，诊断延迟和抗菌药物耐药性（AMR）对有效治疗构成挑战。传统血培养鉴定病原体需要2至5天，这会延迟针对性治疗，使病情恶化，并助长AMR。基质辅助激光解吸/电离飞行时间质谱（MALDI-TOF MS）（美国生物梅里埃公司）可提供快速诊断，有可能改变新生儿败血症的治疗方式。本研究评估了在印度北部一家三级医院中，MALDI-TOF MS与传统方法对疑似败血症新生儿的诊断速度，同时进行细菌学和AMR分析。
2022年11月至2023年11月，我们在一家三级护理医院前瞻性纳入了100例连续的出生后新生儿（<28天），这些新生儿疑似患有败血症（败血症筛查阳性：≥2项参数，如C反应蛋白、白细胞计数）。排除先前使用过抗生素、严重窒息或有畸形的新生儿。血样进行BacT/Alert培养，病原体通过传统方法（2至5天）和MALDI-TOF MS（美国生物梅里埃公司的VITEK MS）进行鉴定。比较鉴定时间（配对t检验，p<0.05）。根据临床和实验室标准协会指南，使用VITEK-2（美国生物梅里埃公司）进行抗菌药物敏感性测试，用卡方检验分析微生物学和AMR数据。
在100例新生儿中（50例早发型败血症（EOS），平均年龄 = 1.34 ± 0.692天；50例晚发型败血症（LOS），平均年龄 = 14.418 ± 9.395天），MALDI-TOF MS鉴定病原体的时间为1.47 ± 0.979天（中位数 = 2天），而传统培养为2.83 ± 0.817天（中位数 = 3天）（p = 0.0052），减少了48%。EOS中以（35%）和（28%）为主，而LOS包括（30%）、（30%）和（仅LOS为10%）。革兰氏阴性菌分离株对美罗培南和厄他培南的敏感性>85%；阿米卡星和黏菌素有效，不过对阿米卡星的敏感性有所降低（60%）。β-内酰胺类药物效果不佳（<40%）。革兰氏阳性菌分离株对利奈唑胺和万古霉素敏感（>90%），但除外 spp.（万古霉素敏感性为0%）。
MALDI-TOF MS将新生儿败血症诊断速度加快了1.36天，能够实现更早的针对性治疗。结合主要病原体（，）和不断上升的AMR（如耐万古霉素），凸显了LMICs中快速诊断的必要性。碳青霉烯类药物仍是可行的经验性选择，但耐药趋势需要管理。本研究支持将MALDI-TOF MS纳入新生儿护理，改善治疗结果并为抗生素政策提供参考。
