Enabling Rapid Diagnostics for COVID-19

through a Decentralized Testing System in

Ahmednagar,

With the objective to provide quick, high-quality, and accessible COVID-19 testing, PATH is implementing a decentralized rapid diagnostic system using Abbott ID NOW and Panbio RDT in in , Maharashtra. Background

In the quest to eliminate COVID-19, testing strategies and other innovations are becoming available at a rapid rate. The state- and district-level governments need support in operationalizing these strategies and innovations.

With respect to ensuring quick, high-quality, and accessible testing services, PATH has received a grant from the Rockefeller Foundation to improve the capacity of and access to COVID-19 testing through systems strengthening. The project aims to streamline the existing testing processes by reducing the turnaround time (TAT) in getting the results and improving the quality of testing through:

• Product innovations: Ensuring the availability of diagnostic platforms and solutions that can reduce the TAT for testing, have better sensitivity and specificity, help minimize errors in data entry and transmission, and identify new variants and mutations through sequencing.

• Process innovations: Optimize the existing process of testing by proposing alternative methods of sample collection and transportation, optimizing networks, and providing additional support such as additional human resources which will reduce the burden on the existing staff in the laboratories.

• Strategic Partnerships: Partnerships are a critical aspect of this project. PATH is partnering with the Indian School of Business, Global Health Strategies, Final Mile, and Ooloi Labs in ensuring availability of testing data, using process optimization tools, using data analytics, developing communication collaterals, and studying vaccine and testing hesitancy.

Details about implementation of the project and its various aspects are discussed subsequently.

Project Implementation

Project Geography

The project is implemented in Sangamner taluka in the Sangamner subdivision of Ahmednagar district in Maharashtra. As per the 2011 Census, Sangamner has a population of 1.4 million. The Rural Hospital (RH) in Sangamner was selected as a dedicated COVID-19 care center. The RH has 72 dedicated beds and 4 intensive care unit beds for COVID-19 patients. The RH has a laboratory dedicated for COVID-19 testing.

Overview of the Testing Landscape – Challenges and Mitigation Strategies

PATH conducted assessment visits in February and March 2021 in the RH, and the following observations emerged:

• Two hundred samples were collected on average in a day in the laboratory. There is a high load on the existing single RT-PCR machine in district (Civil Hospital in Ahmednagar). • There is only one laboratory technician (LT) collecting the samples and making the ICMR portal entry since there is no data entry operator. This has resulted in excessive workload on the LT and long waiting period for people awaiting test results.

• There is no separate waiting room for patients and families.

• The rising cases in the recent months saw the RH experiencing a delay of six to eight days in receiving the reports of the RT-PCR samples sent to the Civil Hospital for testing.

• Largely, it emerged that there is a need to have a separate testing mechanism for patients who are coming for admissions and surgeries. This will help in reducing the load on the existing RT-PCR machine.

By analyzing the existing landscape and the challenges faced by the laboratory, it emerged that decentralized testing catering to the population of the RH will result in better TAT for test results. However, this requires the use of technologies and diagnostic kits which are simple to use, do not require a laboratory set up (point of care), and have a faster processing time.

In light of the identified challenges, PATH decided to implement a testing mechanism which uses two diagnostic tools namely Abbott ID NOW and Abbott Panbio RDT. These solutions meet the two-fold objective of providing (1) a rapid diagnostic kit (RDT) with better sensitivity and specificity and (2) a confirmatory diagnosis. This testing mechanism was implemented to ensure that the RH adhere to the ICMR diagnostic protocol as well as facilitate decentralized testing, lesser patient wait time, faster and accurate results, and reducing the burden on the district-level RT-PCR testing facility.

This testing mechanism is expected to:

• Demonstrate a model that can enable decentralized testing thereby reducing load on the existing RT- PCR laboratories.

• Facilitate the use of rapid diagnostic solutions that can significantly reduce the time taken in getting results. These testing platforms also have high sensitivity and specificity, thus, improving the quality of tests.

• Develop a platform that is disease-agnostic and can be used for diagnosis and testing other diseases. This can also prepare the laboratories for future pandemics and disease outbreak.

• Fill the critical gaps in existing testing mechanism and contribute to overall systems strengthening.

Overview of the Diagnostic Tools

• Abbott ID NOW is a proven Isothermal Nucleic Acid Amplification Technology in an intuitive platform providing fast molecular results that are as quick as 6 minutes to 13 minutes. This is also useful for testing patients who need emergency care or need hospitalization. It requires less training and handholding, and can be kept at room temperature thereby eliminating the need for air conditioning. The results are comparable to the commonly used RT-PCR technology (Details provided in the Annexure 1).

• Abbott Panbio is a rapid antigen test kit that can provide test results in 15 minutes to 20 minutes and has a higher sensitivity and specificity as compared to other RDT devices. Higher accuracy is because it is a newer generation RDT which targets the nucleocapsid as compared to the existing RDTs which utilizes the spike protein of the virus. It is more cost-effective, has biohazard risk reduction features, and does not require BSL-2/3 facility. More details are provided in Annexure 2.

Installing the Diagnostic Tools

As a next step, PATH implemented the solution and installed both the diagnostic solutions to initiate the new testing mechanism. The process is described in the table below. Installation process Details

• Abbott machine, Abbott ID cartridges, Abbott test kits, Abbott Panbio antigen test, Panbio kits, printer, and scanner supplied and installed at the lab. • Separate area created for Abbott ID NOW in the lab. Structural Interventions • Separate waiting area demarcated for patients and families. • Separate registration desk added for registration and RT-PCR portal entry. • Nine participants were trained at the hospital including LT, doctor, nurses, and pharmacist. • The training was conducted on operations, instrument handling, dos and don’ts check list when testing the sample, suggestions on sample specimen and Training handling, and biohazard measures and cleaning procedures for the instrument. • An algorithm was developed by PATH for suspected COVID-19 patients coming to the facility, which was communicated to the staff.

Glimpses of the project implementation activities are shared below:

Abbott ID NOW installed at RH, Sangamner Training on Abbott ID NOW

Separate waiting room for patients and families Follow-up discussions in progress

To streamline the process of testing and obtain faster results, PATH has developed an algorithm for testing in the laboratory.

Challenges and Mitigation Strategies

The challenges identified during implementation and the mitigation strategies identified are described below:

Area Challenge Solution

Human • Shortage of staff • PATH discussed the issue with the district resource including LT, data authorities and the tahsildar has committed to an entry operator and extra LT and data entry operator. security persons. Infrastructure • No waiting area for • Separate waiting area demarcated COVID-19 patients • Separate area created for Abbott ID NOW in the • No area for the new laboratory equipment to be • Separate registration desk added for registration placed and RT-PCR portal entry • No designated registration area Equipment • High cost of the kits • Abbott ID NOW and Panbio supplied and installed at RH, Sangamner Data and • Antigen data entry • Data entry backlog from August 2020 is being operations backlog on ICMR cleared with support from PATH’s data entry portal affecting work operator • High TAT for RT- • Tahsildar has promised an additional data entry PCR results (about 3 operator to 4 days) • Abbott ID NOW technology helps in getting test • Biosafety measures results in 6 to 13 minutes. are in place but • Staff trained in biomedical waste management and biosafety practices personal protection during sample handling by the staff needs improvement.

Impact of the Project

• Data entry backlog from August 2020 is being cleared, and it has improved the workflow.

• Installation of the Abbott ID NOW and Panbio has helped streamline the process of testing and reduce the TAT. Currently, 45% patients are identified by the Panbio antigen test and the remaining 55% are tested using Abbott ID NOW. This has resulted in quicker admission of patients and ensuring prompt care.

• The load on the district-level RT-PCR facility has reduced. Nearly 20% of all confirmatory diagnosis conducted in Sangarmer are done using Abbott ID.

• PATH has positioned itself as a technical partner for Ahmednagar district for COVID-19 testing. The team has been providing technical advice to the district administration regularly.

Learnings

• Decentralizing testing to the collection centers helps mitigate the issues of longer TAT for results. This leads to early diagnosis and early containment of infection.

• A testing algorithm that uses a high-quality screening tool followed by a confirmatory diagnosis reduces the load on the confirmatory diagnostic technology.

• Using a newer generation antigen testing kit can diagnose more cases given its higher sensitivity and specificity. It also takes away the need to deploy more confirmatory tests.

• Adequate human resources should be deployed at every collection center as per their load. Temporary staff with multiple job responsibilities leads to higher attrition and turnover rate causing disruption of services.

• Data entry is a challenge at all collection centers and hiring date entry operators is the need of the hour. This will reduce the load on the LT as well as optimize the use of skilled resources at the facilities ergonomically.

Recommendations

• The state can adopt the combined algorithm of using a faster molecular technology with a highly specific rapid antigen testing in decentralized testing locations. This can provide quicker results while ensuring quality of testing.

• By deploying adequate human resources, we can also implement a dual swab collection technique along with this algorithm. In this scenario, two swabs are collected from the patient at the collection center and stored in separate Virus Transport Mediums. The first swab can be tested using Panbio RDT. Since it has higher specificity, it will identify positive cases accurately. However, if the sample is negative, then the second swab from the same patient can be tested using ID NOW that will give quick confirmatory results. Overall, this will further reduce the TAT.

• In the absence of Abbott Panbio RDT, screening using any ICMR-approved RDT should be institutionalized at every collection center to increase the testing rates as well as decrease the load on RT-PCR facilities.

Annexures

Annexure 1: Product Information on Abbott ID NOW

Annexure 2: Product Information on Abbott PanbioTM Rapid Test Device