India has come out of the devastating second wave, but to be prepared for any next wave, testing, along with Covid-appropriate behaviour (CAB), has to be the first line of defence. Given its vast population, India has a limited capacity to carry out sufficient numbers of tests, but several initiatives have been taken to augment that capacity and increase testing. The global non-profit PATH has made use of two tests the ICMR greenlighted last year to push testing in Maharashtra and Punjab.
 
PATH has been helping the two state governments in implementing two ICMR-approved tests – Abbott ID Now, a molecular diagnostic test or RTPCR, and Panbio Covid-19 Ag rapid screening test, after the ICMR issued an advisory in November 2020, permitting the use of more molecular testing platforms for testing.

Abbott ID Now as of now is the fastest available molecular point to care test for detection of Covid-19 with positive results in five minutes and negatives in 13 minutes.

Along with simple process improvements, training of lab staff and decentralised testing, PATH has demonstrated how states can increase overall capacity of testing, reduce turnaround time as well as cater to vulnerable areas and groups. States can estimate their own requirements and customise strategies accordingly.

Specificity of these tests is comparable to available tests. Panbio has 95% sensitivity and 98% specificity in symptomatic individuals, whereas Abbott ID Now has sensitivity of 95% and specificity of 98%, which are comparable to an RT-PCR. When combined together, sensitivity and specificity of both Panbio and ID Now applied in series is about 83.2%, as compared to the 89% when 70% of the total tests carried out are RT-PCR. Panbio currently costs Rs 205 per test while Abbott ID Now costs Rs. 2,500 per cartridge which is comparable to NAAT testing.

“Unlike decentralised lab testing in Maharashtra where every district has an RT-PCR facility now, Punjab has a regional level centralised hub-and-spoke model where all samples from connected collection centres in districts are sent to seven RT-PCR testing facilities at GMC, Patiala, Guru Gobind Singh Medical and Hospital, Faridkot and GMC, Amritsar that cater to 85% of the state’s test load and national institutes – PBI at Mohali, NRRDL at Ludhiana, FSL at Mohali and FSL at Jalandhar (which was shut down due to bird flu),” Says Dr Preetishirin Katapur, program officer and state lead, Punjab, PATH. “All these sites had a very heavy case load and reports were taking as many as 48 hours and in some cases as many as 8-10 days. At these sites PATH suggested placing extra equipment, provided HR support for lab technicians and data entry operators for reducing load. Staff was trained for sample collection, transportation and storage. Equipment and infrastructure including refrigerators for sample storage and RNA extractors were also set up.”
 
In Mohali District Hospital, she says, Abbott ID Now is being used successfully for emergency patients and it gives result in five minutes if the outcome is positive. For negative results it takes 13 minutes. The downside of the small portable machine is that it can only test a single sample at a given time and therefore in eight hours only 30 samples can be tested.
 
Along with this, the Panbio antigen kit is also being used very successfully in the Mohali hospital and it gives results in 15 minutes. PATH is now in the process of placing another kit at NRRDL in Ludhiana. In Punjab it has donated 2,000 kits of Abbott ID Now and 6,000 kits of Panbio and provided support for genome sequencing for a period of three months.
 
At the Patiala lab, along with genome sequencing, it has set up cloud pathology through which patient data, line list and their samples are transferred from one point to another and results are automatically uploaded to the ICMR platform after the microbiologist approves them. It also sends a message to the patient’s registered mobile number when the sample is received at the laboratory, when it is being processed and when results are out.

“In Punjab, with a single lab doing 8,000-10,000 daily tests, they need 20-30 trained data entry operators to upload all tests. With labs facing severe HR crunch this system also took away the need of having many data entry operators and load on lab in-charge. Decentralisation helps in scaling up and simplifying processes with faster results,” says Katapur.
 
Dr Nimmi Dominic, technical officer, Maharashtra, PATH, adds, “In Maharashtra and Punjab, as soon as we hit ground in our lab assessments, we saw that most of them relied on manual extraction of RNA which is a tedious and longer process and there is always a chance of human error. We introduced automatic RNA extractors to improve capacities at IGGMC and GMC Nagpur. This ramped up tests from 500 to 900-2,000 daily and gives better turnaround time with better quality of results. Cloud pathology was installed in a decentralised set-up in labs in Nashik and Jalna districts and later transitioned back to the district administration. In the Nashik lab, with bar-coding and through cloud pathology entire backlog of 45,000 tests was uploaded to the ICMR site on a single night. Now labs in Nagpur, Bhandara, Ghadchiroli, Nandurbar and Chandrapur have also adopted cloud.”
 
She adds that cloud pathology is very helpful in pool testing where several samples are combined to test and simplifies lab processes. The software is also adaptable to other disease areas and PATH has been advocating it to other states as well. She says Maharashtra has been taking up these solutions, purchasing and installing them everywhere which has reduced work load on data entry operators by 50%-60%.
 
Dr Dominic also adds that at PATH they had started taking two different swabs for every patient from April 2021. The second swab is helpful when the antigen test is negative but the patient has symptoms and can be told to isolate. Such symptomatic cases were tested on Abbott ID Now. This process also decreases the case load on the RT-PCR facility for doing confirmatory tests.  Except RAT all other tests are processed in a centralised laboratory. She adds that with multiple brands of newer antigen tests available in the market now, costs too are correcting and have much better specificity and sensitivity that earlier generation tests.
 
 After interventions, these labs have now become self-sufficient in testing and diagnosis of Covid-19 cases and led to an increase of nearly 10,000 tests every month in total. Dual swabs are now also being collected in Punjab, and NEERI in Nagpur has developed saline gargle which people will find more convenient to use against nasal swab. It has been greenlighted by the ICMR. Besides, the Meghalaya team is also being trained for the same.
 
Along with ISB, Mohali, PATH has also conducted a qualitative study for understanding hesitancy towards testing and vaccination and shared findings with the state governments along with strategies to be adopted.
 
However, both Dr Dominic and Dr Katapur concur that ground reality is different as some states wish to continue with RT-PCR and collection centres don’t want to do antigen tests. They have been scouting for tests that are mobile and do not require lab testing. Self-testing kits are also available now. With newer generation test kits costing slightly more and government procurement on the lowest-cost (L1) criterion in addition to surplus stock of earlier kits, on-ground percolation of this guideline is absent.

Going forward, systems will have to improve and align as there is a limit to testing capacities. These tests are disease-agnostic and aimed to strengthen the overall public health system so when faced with other diseases in future the public health system can leverage them.

Moreover, this is not the only program that the government will be able to carry on in future, as the extra infrastructure that has now been set up will come handy for other initiatives too. “Our project is about newer products, processes and innovation,” they say.