Tuesday, July 21, 2020

Designing and validation of Mobile Laboratory for Clinical Biochemistry Investigation

India is currently facing a demographical and epidemiological shift that has transformed morbidity and mortality profiles, creating new challenges for the health care system. In the remote and rural areas, the presence of health facilities is sparse which affect their consequences. Many of them enjoy good health while underprivileged one suffers from high disease burden and premature mortality. Rural health care faces a crisis unmatched by any other sector and unfortunately diagnostic services have suffered the same fate. The availability of diagnostic services is mainly concentrated around metros and big cities but its penetration in remote area is very negligible. Rural people have to go to urban cities to access diagnostic services, where better diagnostic facilities are available. Diagnostic testing is one of the most promising and evolving industries in the medical field. It is applied for almost 60-70 percent of medical treatments in India. Despite the benefits of many preventive health services, large populations go without needed preventive care. These diseases can be managed and their complications can be prevented by early diagnosis but due to non-availability of i) diagnostic facilities at cheaper rates ii) proper infrastructure and transport facilities iii) health care providers iv) skilled & trained human resource many patients go undetected. Limited resources and continuously growing costs in health care have led to the necessity to assess effectiveness, appropriateness and costs of health technologies including medical devices. But these facilities have a much lower reach in the small towns and villages. Keeping this fact in view the Mobile lab has been invented by Accuster Technologies Pvt. Ltd. Gurugram, which claimed to address all the shortcomings described above. It is a low cost, easy to operate, compact, and portable hand held Clinical Laboratory (diagnostic medical device). It has 16 components i.e. Semi-automated Analyzer, Centrifuge, Incubator, Micropipettes, Micro tips box, cuvettes, Cuvette box, solar panel, Battery etc. It works with Battery or Solar panel or Electricity. There are three ports on back side of mobile lab, 1st port for AC light, 2nd port for Solar panel and 3rd port for Battery. The battery backup is around 8-10 hrs. Total power consumption of Mobile lab is 48W. It can be used in a suitcase (suitcase model) or on a bike (Labike model) which can test all the essential biochemical test parameters like Liver function test (LFT), Kidney function test (KFT), Lipid profile, Blood Glucose, and Hemoglobin levels along with BP and BMI measurement. This machine is so rugged that it can be easily carried to the far flung and remotest locations or carried into emergency situation environments.

In this context, a study has been conducted to assess feasibility and validity of Mobile lab (Suitcase & Labike model) as a point care device which can access best healthcare diagnostic services at the door step for the rural and remote locations. The procedure involved a comparison of results of between both the machines used i.e.: 1) Mobile lab with semi automated analyzer and 2) Beckman Coulter, model no. AU480 with fully automated analyzer (Gold Standard). From the test results we find that Mobile lab is acceptable for all number of tests as mentioned. As the point of care device it provided acceptable limits for Uric Acid, Creatinine, Total Bilirubin, SGOT, SGPT,ALP,HDL,TG and Phosphorus simultaneously it also shows a fair agreement on Urea, Total protein, Glucose and  Cholesterol.

Thus, we concluded that mobile lab would help in providing effective health care diagnosis facilities for the preventive healthcare in remote and rural areas at the door step at reasonable rates. It would also help as a point care solution and also in making the decisions regarding the utilization of this machine in other healthcare settings.

The study was sponsored by ICMR and carried out by Dr Jugal Kishore as Principal Investigator. The outcome of the study was published as book and presented to Hon’ble Union Health Minister of State, Ministry of Health & Family Welfare, Govt of India.

Reference: Kishore J, Tripathi N, Kumar N, Bhatnagar A, Chandra L. Validation Study of Mobile Lab for Clinical Biochemistry in Rural Population of Delhi.J Adv Res Med Sci Tech 2019; 6(1&2): 1-8.


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