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临床试验/CTRI/2025/07/090128
CTRI/2025/07/090128尚未招募不适用

Diagnostic Accuracy of a Non-invasive Point of Care Hemoglobin Estimation Device (EzeCheck) Compared with Hematology Analyzer for Anaemia Assessment: A Community based Study

Bharati Vidyapeeth DU Medical College1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年7月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
Sensitivity and Specificity of EzeCheck equipment for detection of Anaemia

研究概览

简要总结

Anemia is a global public health problem faced especially by people from low and middle-income countries including India. It is prevalent across all age groups from childhood to adulthood. The Government of India is committed to combating anemia. Anemia Mukt Bharat Program under POSHAN Abhiyan uses the 6X6X6 strategy and aims to reduce the prevalence of anemia among various groups. Addressing anemia requires a multifaceted approach encompassing improved nutrition, iron supplementation, and, critically, effective diagnostic strategies.

Clinical diagnosis of anemia is subjective and depends upon various factors like complexion of patient, availability of natural/good light and clinical expertise of the health care worker. While laboratory-based methods, such as complete blood counts using hematology analyzers, are considered the gold standard for hemoglobin estimation, their widespread use is often hindered by logistical constraints, particularly in resource-limited settings and remote areas. The mass screening of the targeted population at least once in six months or during the school health check-up of adolescents will help identify the patients with anemia and they can be treated with an appropriate dose and duration. The current program uses invasive digital hemoglobinometers but only for a limited population of pregnant women and those with suspected anemia. EzeCheck is another point-of-care, non-invasive device that eliminates needles and blood draws. These innovative devices prioritise user-friendliness, portability, affordability in low-resource environments, and reduced reporting time, ultimately enhancing patient satisfaction. Validated by ICMR, this device can be used after the age of 4 years and shows moderate agreement with a haematological auto-analyser. Of 1457 participants, the study had only 16 children of 4-11 years and 79 from 12 to 18 years. There was no specific representation of pregnant women. This noninvasive point-of-care device has the potential to be used for mass screening. However, rigorous evaluation of its diagnostic accuracy in diverse population subgroups, particularly within the Indian context, is essential before widespread implementation can be considered. So, we plan to evaluate the diagnostic accuracy of the EzeCheck device in the community, especially in the target groups identified under Anemia Mukta Bharat.


研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Children from the age of 4 to 17 years and adults from 18 years and above residing in the study area.

排除标准

  • Application of henna or injury to fingers of left hand.

结局指标

主要结局

Sensitivity and Specificity of EzeCheck equipment for detection of Anaemia

时间窗: Cross sectional study so will be done at baseline visit

次要结局

  • Pearson correlation between EzeCheck and auto-analyser haemoglobin values(Cross sectional study so will be done at baseline visit)

研究者

发起方
Bharati Vidyapeeth DU Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sonali Palkar

Bharati Vidyapeeth DU Medical College Pune

研究点 (1)

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