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, 1^st port for AC light, 2^nd port for Solar panel and 3^rd 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.

Hypertension and its Associated Risk Factors Detected through Portable Mobile Lab at PHC, Najafgarh, Delhi

Hypertension, the world’s leading risk factor for global disease burden, is expected to cause more than half of the estimated 17 million deaths per year resulting from cardiovascular disease (CVD) worldwide. The presence of other risk factors such as hyperlipidaemia, cigarette smoking, diabetes, and elevated age can greatly increase the risks associated with even mild hypertension. Defined as an elevation of systolic blood pressure (BP) beyond 140 mm Hg and diastolic more than 90 mm Hg, hypertension is strongly correlated with adverse outcomes such as stroke, ischemic heart disease, heart failure, and end stage renal disease. Although the condition is common, readily detectable, and easily treatable, it is usually asymptomatic and often leads to lethal complications if left untreated. According to Global Burden of Disease Hypertension is the 4th contributor to premature death in developed countries and the 7th in the developing countries with the overall prevalence of 26.4% among the adult population in 2000. Escalating cardiovascular risk factors such as smoking, high blood pressure (BP), high low density lipoprotein (LDL) cholesterol, low high density lipoprotein (HDL) cholesterol, metabolic syndrome and diabetes are the major risk factors associated with the increasing CVD in India. Many low- and middle-income countries, most of which are in the midst of the epidemiological transition, face rapidly increasing prevalence of hypertension in the context of limited healthcare resources.10 Thus, in these countries developing innovative and cost-effective solutions to improve hypertension diagnosis as well as management and control remains a key priority.

India, being a culturally and socially diverse nation, differences would be noted in the region-wise prevalence of hypertension, but research regarding the same is inadequate in the rural areas of Delhi. This inadequacy necessitated us to conduct this study with the objective of assessing the prevalence rate of hypertension and its associated risk factors including the socio-demographic correlates of hypertension using innovative and cost effective technique. During OPD visits, the objectives of the study were explained to the participants and data was collected by personal interviews using predesigned, pretested and semi structured questionnaires to assess their socio-demographic profile like age, sex, religion, profession, educational status and so forth. WHO STEPS approach was employed to study the profile of the hypertension in the population. During OPD visits, at the sub-centers under VMMC & SJH New Delhi, the objectives of the study were explained to the participants and data was collected by personal interviews using predesigned, pretested and semi structured questionnaires to assess their socio-demographic profile like age, sex, religion, profession, educational status and so forth. WHO STEPS approach was employed to study the profile of the hypertension in the population. Information on behavioral risk factors were collected i.e. tobacco use, alcohol use and related factors using a questionnaire; clinical measurements such as weight, height and blood pressure were obtained using Mobile lab which was already validated through ICMR. Out of total 500 subjects, 193 (38.6%) were males and 307 (61.4 %) were females where as 92.8% were Hindus, 6.4% were Muslims, and 0.8% were Christians. The proportion of literate was 77.2%. Unemployment among the study subject was 21.4%. The reported prevalence rate of hypertension was (n=101/500) 20.2% of which, a higher prevalence was noted among males (n=41/193) 21.2% as compared to females (n=60/307) 19.5%.

To conclude, hypertension increases the load in term of morbidity and indirectly put immense economic burden on already economically stressed Indian economy. The high prevalence of hypertension, noted in the study, necessitates the need to plan future community-based studies in the same region with an additional objective to quantify the lifestyle factors responsible for the same.

Reference: Tripathi N, Kishore J, Kumar N. Hypertension and its Associated Risk Factors Detected through Portable Mobile Lab at PHC, Najafgarh, Delhi. Epidem Int 2018; 3(3): 1-7.

About Jugal Kishore Written by Dr. Ravi J Kumar

Child Sexual Abuse and Covid 19 pandemic

https://youtu.be/uUwGSWQyRmU

Recovery Rate of COVID 19 in Delhi

200,000 recuperate, rate of recovery stands at 54%

Paramilitary personnel leave a treatment facility in Greater Noida after recovering from Covid-19. SUNIL GHOSH/HT PHOTO

Rhythma Kaul

letters@hindustantimes.com

NEW DELHI : The number of patients who recovered from the coronavirus disease (Covid-19) in India crossed 200,000 on Thursday but the country’s recovery rate still trailed the global average.

Of the 381,010 people who tested positive for Covid-19 in India, 205,092 recovered as of Thursday, according to data collated by HT.

The global recovery rate stood at around 55% while that in India was around 53.8%.

Maharashtra, which has roughly a third of all infections in India, logged the highest number of absolute recoveries at 60,838. It was followed by Tamil Nadu at 28,641 and Delhi at 21,341.

In terms of recovery rate — which is the ratio of the number of patients recovered to the number of patients infected — among major states, Rajasthan topped the list with 77.5%, followed by Madhya Pradesh at 75.5%.

“India’s recovery rate has been steadily going up, which is a good news. More than 50% of those having tested positive have recovered and taken out of active medical supervision,” said Lav Agarwal, joint secretary in the health ministry, last week.

A section of experts said the increasing number of recoveries was a good sign.

“When the number of those infected in a day is the same as number of people recovering then it usually highlights the fact that the disease outbreak is going to stabilize and start declining in some time, unless some other variables come in such as floating population, new births etc. that change the entire dynamics,” said Dr Jugal Kishore, professor and head, community medicine department, Safdarjung Hospital.

But other experts said it was important to find out how many of the severely ill patients had recovered.

“Earlier all positive patients, even those with mild symptoms, were being treated in a hospital, so 50% recovery right now wouldn’t mean much. Now that hospital admissions are being restricted and largely serious patients are being kept in a hospital it remains to be seen what is the recovery rate based on that the real picture will emerge,” said Dr Charu Hans, former head, microbiology department, New Delhi’s Ram Manohar Lohia (RML) Hospital.

New Rapid Antigen Test for COVID 19

456 Covid-19+ on first day in new rapid antigen testsSURGE : Results not yet reflected in city tally, which nears 50k with another record rise

Amit Shah at a meeting with CM Kejriwal and other officials.PTI

Anonna Dutt

anonna.dutt@htlive.com

New Delhi : Four hundred and fifty-six people were found infected with the coronavirus disease (Covid-19) in the national capital in a new testing programme involving quick-result kits across containment zones, where 7,040 samples were collected on Thursday.

The tests were carried out through new “antigen” test devices that can be used on-site, and Thursday’s rapid sampling numbers are close to the 8,700-odd RT-PCR tests carried out by labs across the city on Wednesday, underscoring how such kits can ultimately speed up the test-trace-isolate process that health experts across the world see as crucial to containing the pandemic.

Officially, the city added 2,877 new cases on Thursday, according to the government’s daily health bulletin, that showed that there had been 65 new fatalities. The new infections came from 8,729 RT-PCR tests, resulting in a confirmation rate of 3.3%. The results from the antigen test results were not included in the bulletin.

Rapid antigen testing was done at 193 centres in Delhi on Thursday. A total of 7,040 people were tested of whom 456 tested positive for the infection. At the beginning, those people are being tested whose houses are in the containment zones,” tweeted acting health minister Manish Sisodia on Thursday.

The new programme is part of the Union and state government’s effort to ramp up the number of tests in Delhi by six times by the end of this week.

The city administration has asked district teams to test those who live in the 242 containment zones in Delhi and are willing to be tested. The new test, developed by a South Korean company and manufactured in Manesar, is highly specific (99.3% to 100%) -- meaning a positive result on the test is a “true positive” and does not need any confirmatory test.

The sensitivity is between 50.6% to 84% depending on the viral load, meaning those who test negative might still have the infection and are advised to go for a test through the more reliable RT-PCR method if they show symptoms of the disease.

The tests began on a day the government announced that lab tests will be capped at ₹2,400, a day after it was suggested by a committee formed by the Union government.

“Two important decisions have been taken in connection with Covid-19 testing in Delhi: The rate for testing has been reduced to ₹2,400 and from today, rapid antigen testing has begun by which results will be available in 15 minutes,” said chief minister Arvind Kejriwal in a tweet, adding that he hoped the decisions will address problems faced by the people.

Apart from being quicker than lab-based RT-PCR tests, antigen tests are cheaper – one kit costs ₹450 – and differ in technology as they look for specific protein associated with the Sars-Cov-2 virus, the pathogen that causes Covid-19. The lab tests look for the exact nucleic signatures of the virus.

A third mechanism that can give quick results is the antibody test that checks for the presence of disease-fighting antibodies in a person’s blood, but these have proven to be unreliable and scientists are not sure when and for how long the antibodies can be detected.

When antibody tests were rolled out on April 21, only 62 people were tested in one district on the first day. The test was discontinued from the following day after several states reported wide variation in results from the China-sourced kits.

“This is certainly a good way of ramping up testing – these tests are cheaper and faster. And at the community level, the test will enable us to identify more cases of Covid-19, they can then be asked to remain in isolation at home preventing further spread of the infection,” said Dr Jugal Kishore, head of the department of community medicine at Safdarjung hospital.

“The test is not very sensitive, meaning it can give false negative reports. If it’s a false positive, all we would be doing is keeping more people in isolation. Since there is a chance of false negatives with this test, it will have to be reconfirmed. Having said that, the sensitivity of the RT-PCR test is also about 67% and not very different from this test,” he added.

On Thursday, people in containment zones began reaching the testing facilities – set up mostly in neighbourhood government schools, dispensaries and mohalla clinics – where they were seated at 1m distance before they were administered the test.

At the Sarvodaya Kanya Vidyalaya in Naraina in west Delhi, around 50 people gathered after community volunteers reached out and persuaded people living in a nearby containment area to come to get diagnosed.

Four people in a full-body suit in an air-conditioned room called people one by one. One paramedic collected naso-pharyngeal swabs, before a second one took it and inserted into a tube. This process is meant to inactivate the virus, and dissolve it in a solution that was then put on the main test strip that would give the final result.

A third person numbered the antigen kits with a permanent marker and wrote down the name of the tested person along with the kit number on another sheet. The fourth entered this data to an online portal.

“There were teething troubles on Thursday, with a lot of the time being wasted on setting up the centres. It will be streamlined in a couple of days,” said a district-level health official, asking not to be named.

“The antigen testing is very beneficial for district teams as we get a result immediately and ask people to remain in quarantine if they have the infection. This prevents further spread. It also ensures that people who do need to be admitted to hospitals, reach there in a timely manner,” this person added.

Apart from the containment zones, the antigen tests are likely to be rolled out in Delhi’s hospitals within a couple of days. In a hospital setting, the ICMR recommends the test be used for those who develop influenza-like symptoms, are immune-compromised because of an existing condition, or are undergoing procedures such as chemotherapy and dialysis.

“We have already ordered the tests and should get it within a couple of days. Once that happens, we will start testing patients who fit the ICMR criteria with the antigen kits. Those who test negative will be tested using RT-PCR. In the absence of the antigen test, we would have had to test all the people using RT-PCR, which is time and resource-intensive,” said Dr DK Sharma, medical superintendent of AIIMS.

Contact Tracing, early diagnosis and isolation are the main tools of Covid 19 Containment

https://www.livemint.com/news/india/india-slackens-contact-tracing-as-country-opens-up-11591709082961.html