Amid rising cases of coronavirus infections across the state, the Haryana government will launch a state-wide Sero-survey from August 17. In collaboration with PGIMER, Chandigarh, the survey will be conducted in all 22 districts till August 20.
Why has Haryana felt the need to conduct a state-wide sero survey?
Despite a high recovery rate of 82.91 per cent, the state continues to witness a spike in new cases of coronavirus infections across all the districts. The Haryana government decided to launch the state-wide Sero-survey to take a decision on further planning and monitoring the Covid-19 preparation. Due to high proportion of asymptomatic/ mild infection data available only for laboratory confirmed cases that does not capture the real burden/ spread of the disease in the population, the state decided to go in for a thorough Sero-logical detection of specific antibody against SARS Cov-2 which can help government estimate the true number of infections.
What does Haryana want to achieve from this Sero-survey?
A Sero-survey was conducted in May by ICMR in 83 districts that included Kurukshetra in Haryana. Similarly, NCDC conducted a Sero-survey in Delhi. On similar patterns, Haryana will conduct its survey in all 22 districts by using lgG ELISA Test kits. The main aim of the survey is to monitor exposure of general population to Coronavirus infection in Haryana and to estimate the sero-prevalence of anti Sars Cov-2 lgG antibodies among population of the state.
What is the methodology being adopted and what shall be the sampling design?
The state government’s survey-study design would be cross sectional with stratified multi-stage random sampling. The sample size shall be estimated at the district level with 850 participants from each district. These samples – 850 participants – will be divided into two stratas – Rural and Urban. Haryana’s ratio of rural to urban is roughly around 60:40. The 850 participants would be divided into two clusters – 500 (rural) and 350 (urban). Urban Areas will further be divided into four clusters and each cluster shall susbequently be divided into four quadrants. A total of 88 samples will be taken from every cluster – 22 households from each of the four quadrants.
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Similarly, rural areas shall be divided into 12 clusters and each cluster into four quadrants. A total of 44 samples will be taken from each cluster – 11 households from each quadrant. To achieve this, multistage sampling will be done. In the first stage, four primary health centres (PHCs) from each district have been selected randomly. In second stage, one sub-centre from each PHC has been selected randomly. In the third stage, one subcentre village has been selected and one non-SC village has been selected randomly. For subcentre villages, where there was no non-sub-centre village and adjoining non subcentre village will be selected randomly.
How will the households be selected?
Each selected cluster will be geographically divided into roughly four quadrants. Middle of each quadrant will be marked with its GPS location. The survey team will visit consecutive houses from this point till required sample size for that location is completed. It will be about 11 houses per GPS location in each cluster in rural cluster and 22 in urban cluster.
Who all shall be included among the participants?
Anybody above 18 years can be included as a participant with their consent. One individual in each household shall be selected.
How does the state plan to ensure human participant protection and ethics committee approvals?
Haryana’s ACS (Health), Rajeev Arora, said the state is undertaking the sero-surveilance as part of the national guidelines. “Districts are supposed to do this in routine to take evidence based public health actions. This type of surveillance is exempted from the ethics committee approvals. However, proposal will be submitted to IEC committee of PGIMER, Chandigarh for exemption. The participants will be informed about the study objectives, importance of the survey and interpretation of positive result. An informed verbal consent shall be taken. After laboratory result become available, district nodal officers will communicate the results on phone and will counsel the participate to take further actions as per the guidelines”, said Arora.
Who all shall comprise the team for conducting Sero-survey?
For each cluster, there will be one team comprising one medical officer (MBBS, BDS or AYUSH), one healthcare worker of ANM/ LHV level preferable of the selected health facility, one laboratory technician or trained phlebotomist and one supervisor for every two clusters (DSO/ Deputy Civil Surgeon).
How are the teams being trained?
A basic training shall be given to the health officer and field teams using digital mode. This will involve informing them about the overall objectives of the survey, how to select the GPS cluster point within a selected cluster, how to select the first house, how to approach the family and take consent, how to fill the form using digital mode, how to prepare blood sample collection kit including vacutainers and how to draw blood samples, label, transport and store them.
What shall be the procedure for sample collection?
The study teams will visit the randomly selected households and brief them about the survey. A verbal consent will be taken. Doctor in the team will ask the questions and the other person will record on the form. At the end of the interview, the doctor will cross check the form for its completeness and correctness. At the end of the interview, laboratory technician will draw 5ml blood, label it and store it. At the end of sample collection from the cluster, all samples should be immediately transported to the designated laboratory for processing. ELISA kit and methodology generated for estimation of lgG antibodies will be used as per ICMR guidelines.
What is the outcome that state expects out of this Sero-survey?
“The study will help the state determine the burden of Covid-19 infection at the community level and monitor the trends in transmission of SARS-COV-2 infection. The study findings will be useful to guide in designing and implementing appropriate containment measures. Existing and ongoing data of laboratory results will be used to calibrate the positivity rate among tests of RT-PCR in all districts for ongoing epidemic control and mitigation. Rate of change in prevalence between two rounds of survey will be analyzed for extrapolation of rate of change positivity and case finding”, Arora said.
What will be PGIMER’s role in the survey?
PGIMER is required to do the protocol preparation, conduct the training and mentorship, provide the quality assurance, data compilation and report presentation and submission of final report for dissemination. There will, however, be no financial liability on the institute.
What are the logistics involved?
Forms and formats – 1000 forms being printed per district including 850 forms for filling and 250 per district to compensate the wastage. The budget for the same is being drawn from NHM Covid-19 budget. Maps of the selected clusters will be used for Geo tagging. Laboratory materials for collection of blood samples will be arranged by the districts, including syringes, needles, vacutainers, cotton swab rolls and 70% alcohol for swab. Permanent black pen markers with fine tips (two per team), storage and transport of laboratory materials (vial stands), biomedical waste management supplies (yellow bags, black bags, puncture proof leakproof translucent containers, stickers of BMW hazard and label stickers) and at least two functional ELISA machine with related materials etc. and tourniquet. Districts have also been given the option to hire ELISA machines where it is not available or is non-functional. In view of the sensitivity involved in the survey, adequate police protection shall be provided to each team. Local guides and police escorts shall be provided to each of the State supervisory teams.
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