Clinical evaluation, validation and stability testing of a developed paper-based blood grouping diagnostic test device

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-03-31 DOI:10.1016/j.cca.2025.120276

Shahila Parween , K.V.S. Ratnam , Arjun Jayachandran , P.R. Raja Ram , Prajna Arpita , Harsh Vardhan Shrivastava , Amit Asthana

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Abstract

Blood transfusion necessitates an obligatory test to examine donor-recipient compatibility. Regardless of the typical traditional methods, new blood typing approaches are considered for uncomplicated, correct, and precise testing. In this study, we evaluated the rapid and affordable point-of-care blood typing device and explored new approaches to increase its stability/shelf life. A total of 729 blood samples were validated using this paper-based device. Medical students/staff (total 260) of MNR Medical College & Hospital, Telangana, India, and 57 volunteers from India MedTech Expo 2023 and G20 3rd Health Working Group Meeting organized by Govt. of India, were considered for on-spot testing. The participants were asked to sign the consent form and enter their blood groups, which were later used for confirmation and validation. Out of 260 medical students/staff, this blood typing paper device successfully validated blood groups of 204 samples and tested 45 unknown blood groups. It also provided corrected blood groups to 11, thus having a sensitivity of 100 %. The device tested on MedTech Expo and G20 Health Meeting volunteers showed 100 % specificity. Around 400 blood samples collected from the hospital were tested with the paper device and compared simultaneously with the conventional glass slide method. 12 blood samples were tested via tube method and compared to paper devices. The sensitivity in all cases was superior to that of the traditional method with 100 % specificity. The developed device with a new biofunctionalization strategy exhibited excellent stability for 3 and 6 months at room temperature and 2–8 °C, respectively. This simple and easy diagnostic test device epitomizes a major stride towards enabling comprehensive screening of blood typing both in children and adults. It signifies its feasibility in resource-limited clinical settings towards making a positive diagnosis.

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一种新型纸质血型诊断试验装置的临床评价、验证及稳定性试验。

输血必须进行强制性检查，以检查供体与受体的相容性。不考虑典型的传统方法，新的血型方法被认为是简单、正确和精确的测试。在这项研究中，我们评估了快速和负担得起的点护理血型设备，并探索了增加其稳定性/保质期的新方法。共有729份血液样本使用这种基于纸张的装置进行了验证。印度特伦甘纳邦MNR医学院和医院的医学生/工作人员（共260人）以及印度政府组织的2023年印度医疗技术博览会和二十国集团第三次卫生工作组会议的57名志愿者被考虑参加现场检测。参与者被要求签署同意书并输入他们的血型，这些血型随后被用于确认和验证。在260名医学生/工作人员中，这种血型纸设备成功地验证了204个样本的血型，并测试了45个未知的血型。它还提供了校正血型到11，因此具有100 %的灵敏度。在MedTech Expo和G20卫生会议志愿者身上进行的测试显示，该设备的特异性为100% %。从医院收集的大约400份血液样本用这种纸装置进行了测试，并与传统的玻片法同时进行了比较。12份血样经试管法检测，并与纸制仪器进行比较。所有病例的敏感性均优于传统方法，特异性为100% %。该装置具有新的生物功能化策略，在室温和2-8 ℃下分别表现出3个月和6个 月的优异稳定性。这种简单易用的诊断测试设备是实现儿童和成人血型全面筛查的一大进步。这表明在资源有限的临床环境中，它对做出积极诊断是可行的。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.