Such test kits sans an inbuilt data capture system have potential to derail the state government’s efforts to flatten Covid-19 curve as many positive cases may go unreported. The state government needs to get tough with such illegal sales.
TFM Report
STANDARD Q COVID-19 Ag Test kit, which is strictly for medical professional use, is being sold as Covid-19 home test kit in Manipur. This product is not among the list Covid-19 home test kits approved by the Indian Council of Medical Research. It does not have an inbuilt system of data capture mechanism, one of the key specific prerequisites set by ICMR to validate it as a self-test kit. There are concerns about possible misuse of the test kit and risk of improper disposal of biohazard wastes.
STANDARD Q COVID-19 Ag Test is manufactured by SD Biosensor, South Korea/India. Its ‘instructions for use’ manual has clearly stated that STANDARD Q COVID-19 Ag Test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patients with clinical symptoms with SARS-CoV-2 infection… The product is strictly for medical professional use only and not intended for personal use.
However, it is being sold in the state at 400-800 per sachet while three self-test kits approved by ICMR are priced at Rs 250. As per official video of SD Biosensor, STANDARD Q COVID-19 Ag comes in a box, which has kit enough to conduct tests on 25 people as the product is supposed to be used in healthcare settings for large scale testing.
The Frontier Manipur spoke to one of STANDARD Q COVID-19 Ag’s distributors based in Chennai. They said the product comes in a set of 25 tests and priced at 6,552.50 (including 5% GST). However, they refused to entertain the order when TFM said the product is for sale in a pharmacy for self-test use. “Though STANDARD Q COVID-19 Ag is easy to use, selling a single piece will not be feasible as other kits required for a test are in 25 sets except cassettes which are in separate sachet for each piece,” they said.
However, pharmacies in Manipur sell SD Biosensor’s antigen test kit loose, not in box. They give one cassette and one sterile swab in sachets and extraction buffer tube and nozzle cap not even packed. No user manual was provided with the kit.
According to ICMR’s norms,all the self-test kits for Covid-19 must have an inbuilt system of data capture through mobile softwares or any other suitable technology and the kit insert should include detailed instructions for usage, interpretation and disposal of the test kit.
However, SD Biosensor does not have its dedicated App for registration of users’ credentials and report results which is mandatory for Covid-19 self-test kits approved by ICMR. STANDARD Q COVID-19 Ag does not have an inbuilt system of data capture through mobile softwares QR code or any other suitable technology for accurate report generation. There is a high chance of many positive cases going unreported.
Infectious disease control, surveillance and prevention demand accurate real-time data of positive cases. The Government’s policy is guided by timely surveillance data. Under-reporting of cases will create blind spots and can potentially derail whole efforts of the state government to flatten the Covid-19 curve.
Self-test kits approved by ICMR
ICMR has validated 118 Antigen-based Rapid Test Kits so far. Though STANDARD Q COVID-19 Ag appeared on top of the ICMR list, it is not in the three approved self-test kits. As per ICMR notification dated June 28, 2021, ICMR-approved three test kits are CoviSelfTM (PathoCatch) COVID19 OTC Antigen LF device of Mylab Discovery Solutions Ltd, Pune (Maharashtra); PanBio COVID-19 Antigen Rapid Test Device of Abbott Rapid Diagnostics Division, Chicago (Alere Medical Pvt. Ltd., Gurugram); CoviFind COVID-19 Rapid Ag Self-Test of Meril Diagnostics Pvt. Ltd., Vapi (Gujarat).
These covid-19 self-test devices are priced at Rs 250 per kit. One self-test kit contains a safe swab, test card, a prefill extraction tube, disposal bag, user manual and has a validity of maximum shelf life of 24 months. CovidSelf and COVIFIND can be used by 18 years and older individuals themselves or by an adult for individuals between 2 and 18 years old. The Panbio™ COVID-19 Antigen Self-Test is authorized to be used manually by untrained lay users (self-testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. Children under 14 years should be supported by an adult.
To use the kit, users will have to first register into the test-kit firm’s respective app and fill in the credentials before taking the sample with the swab. Every test kit carries Unique QR Code for accurate report generation.
In the next steps, users will have to put the sample in the tube, break the swab and close the nozzle cap. Following this step, users should put two/three drops on and wait for 15 minutes to get the results. The test result must be reported through the App. The final step is to dispose of the kit in a disposable bag.
ICMR’s criteria for approval of home-based testing solutions:
According the ICMR order dated April 27, 2021, all manufacturers intending to market such tests in India must ensure the following:
i. All material for sample collection, testing and disposal should be part of the kit per se.
ii. The kit insert should include detailed instructions for usage, interpretation and disposal of the test kit.
– All such tests must have an inbuilt system of data capture through mobile softwares or any other suitable technology.
– All manufacturers are advised to liaise with the data entry team of ICMR to ensure compatibility of data flow into the ICMR COVID-19 testing portal. Once the compatibility is ensured, DCGI may be approached for approval.
– Manufacturers who do not have a system or are unable to synchronise data flow with ICMR, may not be considered for marketing permission under the category of home-based testing solutions and considered for approval under another appropriate category.
Matter of grave concern
A concerned citizen has raised a red flag over the issue. He has told The Frontier Manipur that on June 19, 2021, the online delivery service put up an Instagram post stating that COVID-19 home testing kit is available with them at Rs 400. The picture was that of the Standard Q COVID-19 Antigen test.
“I asked them how they were selling a test-kit which is not approved for home use. They replied saying that the image was just for representative purpose and that they were actually selling the MyLab COVID-19 self-test kit,” he said. When I further asked why they were selling the Rs 250 test kit for Rs 400, they didn’t answer and went silent, he added.
“On June 29, 2021, a friend of mine sent a sms that her family got positive results on the Standard Q COVID-19 test kit. Upon further inquiry, I came to know that a few other people used the same test kit. They got the test kit from a pharmacy in the Lamphel area,” he said.
“There are not only biohazard risks of disposal but also a deliberate attempt to loot the public as test kits costing just Rs 250 sells at Rs 400-Rs 800,” he added.
How does STANDARD Q COVID-19 Ag find ways into pharmacies?
Many are curious about the source of SD Biosensor’s kit in pharmacies in the state. There are two possibilities for the pharmacies to get their hands on STANDARD Q COVID-19 Ag—through distributors or black marketers. If distributors do not supply SD Biosensor’s antigen test kits to pharmacies for home/personal use, how Manipur pharmacies are selling the kit for self-test is a big question.
Chief Minister N Biren Singh had on June 1 launched the aggressive mass testing drive in the state to flatten the Covid-19 curve. The RAT kit used by state health department during this aggressive mass testing drive are SD Biosensor’s STANDARD Q COVID-19 Ag, Meril Diagnostics’ COVID-19 Antigen Detection Test and Alpine Biomedicals’ Alpine COVID-19 Antigen Rapid Test kit.
The state government had procured these kits in a large quantity and several teams consisting of medical staff conducted mass testing across the state. There is a strong possibility of these kits finding their way into the black market and landing them in pharmacies.