Corona Detection with Agappe Chitra Magna Commercial Launch & Indian Accredited PPE testing facility: Good News

RNA extraction kit Agappe Chitra Magna launched commercially for detection of COVID 19

Textiles Committee comes up with fully indigenous Design and Make in India PPE Testing Equipment

The unveiling of Accredited PPE testing facility in Mumbai under Textiles Committee will provide much- needed and timely Quality Assurance to Governments as well as PPE body coverall manufacturers: Secretary, Textiles Committee

Agappe Chitra Magna is a magnetic nanoparticle-based RNA extraction kitfor use during testing

21 May 2020 Dr VK Saraswat, NITI Aayog member and President of Institute body of Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST)announed here today the commercial launch of Agappe Chitra Magna, a magnetic nanoparticle-based RNA extraction kit for use during testing for detection of COVID-19. The announcement was made by Dr VK Saraswat, at a programme attended by Prof. Ashutosh Sharma, Secretary, DST, Dr Asha Kishore, Director SCTIMST, Dr HK Varma, Head Biomedical technology and scientists of the institute, through a video conference.

The RNA extraction kit was developed by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, an Institute of National Importance of the Department of Science and Technology (DST) along with Agappe Diagnostics Ltd, an in vitro diagnostics manufacturing company based in Cochin. 

“The commercial launch of the kit is a major step to make India self-reliant in detecting COVID 19 and can help increase the rate of testing and bring down its costs, a crucial step for combating the pandemic. It can also be an example of rapid commercialization and implementation of a state of the art technology for the world to emulate,” said Dr. Saraswat while announcing the launch.

He said, “The transformation of R&D from purely generation of knowledge to generation ofvalue demands increased investment and a strong, empowered R&D managementsystem. Synchronising the efforts of academia, national laboratories and industrieswould be most essential in this transformed ecosystem. Only when this symphony isplayed, India will emerge as a technologically and economically strong nation”.

Professor Ashutosh Sharma said, “this is an example where scientists and industry worked in tandem with a purpose to serve an urgent need. The innovative process of conjugating the RNA with magnetic nanoparticles and increasing their concentration in one place by applying a magnetic field is a breakthrough that allowed the high sensitivity of RT-LAMP test from SCTIMST. Multidisciplinary lateral thinking and industry involvement right from the beginning allowed the technology to be developed into a product that was suited to meet the need of the hour”.

Dr. Sarawat and Prof. Sharmacongratulated the entire team of Sree Chitra and AgappeDiagnostics for coming out with such a wonderful solution for addressing the need ofthe country.

“Promotion of indigenous medical technologies is the primary mandate of the Institute.Besides in vitro diagnostics and development of point of care, devices is a segment that we recently forrayed into. The molecular medicine division headed by Dr Anoop Kumar, Senior Scientist, has been working on such diagnostic platforms and we are excited at the prospect of having developed the magnetic nanotechnology-based RNA extraction technology that will reduce our import dependence and facilitate cost-effective confirmatory testing of COVID -19” said Dr Asha Kishore, Director, SCTIMST.

The launch programme was organized by SCTIMST in collaboration with Agappe Diagnostics Ltd at the Biomedical Technology Wing of SCTIMST, and it was followed by the first sale of the product by Mr. Thomas John, Managing Director, Agappe Diagnostics, to officials from Amrita Institute of Medical Sciences, Kochi.

Inexpensive, fast, and accurate testing for COVID-19 virus is the cornerstone of containing its spread and providing appropriate help to the infected. The Chitra Magna, an innovative RNA extraction kit developed by SCTIMST under the leadership of senior scientist, Dr. Anoop kumarThekkuveettil, was transferred to Agappe Diagnostics in April 2020, and will now be available in the market as Agappe Chitra Magna RNA Isolation Kit. This product has been independently validated at National Institute of Virology for Covid19 RNA isolation. Central Drugs Standard Control Organisation (CDSCO) has given approval for the commercialization of this kit. The kit can be used for RNA extraction for RT-LAMP, RT-qPCR, RT-PCR and other isothermal and PCR based protocols for the detection of SARS-COV-2.

It uses an innovative technology for isolating RNA using magnetic nanoparticles to capture the RNA from the patient sample. The magnetic nanoparticle beads bind to the viral RNA and, when exposed to a magnetic field, give a highly purified and concentrated RNA. As the sensitivity of the detection method is dependent on getting an adequate quantity of viral RNA, this innovation enhances the chances of identifying positive cases.

It is estimated that India would require about 8 lakh RNA extraction kits per month during the next six months, and Agappe Chitra Magna RNA Isolation Kit priced around Rs. 150 per kit is expected to reduce the cost of testing and the country’s dependence on imported kits which cost around Rs 300. Agappe Diagnostics has a manufacturing capacity of kits for performing 3Lkah kits per month. 

(For more details, please contact: Ms. Swapna Vamadevan, PRO, SCTIMST, Mob: 9656815943, Email: pro@sctimst.ac.in)

Textiles Committee comes up with fully indigenous Design and Make in India PPE Testing Equipment

The unveiling of Accredited PPE testing facility in Mumbai under Textiles Committee will provide much- needed and timely Quality Assurance to Governments as well as PPE body coverall manufacturers: Secretary, Textiles Committee

Mumbai, May 21, 2020 Textiles Committee, Mumbai too will now test and certify PPE body coveralls required for healthcare workers and other COVID-19 warriors. The inclusion of Textiles Committee as the ninth approved laboratory to test and certify body coveralls has been announced by the Ministry of Textiles yesterday evening.

Speaking on the development, Secretary, Textiles Committee and Additional Textile Commissioner, Ministry of Textiles, Ajit Chavan explained how the Committee rose up to the occasion to surmount the challenge of non-availability of reputed domestic manufacturers of PPE testing equipment: “Transparency, objectivity and professional service is not new to The Textiles Committee. This is just one more initiative by the Committees' dedicated workforce to rise up to the occasion and do our bit in the fight against COVID-19 pandemic. We faced the humungous challenges of non-availability of domestic manufacturers of repute and incessant delay/long gestation period to import machine from China as also challenges of ever-increasing prices by the opportunist companies in China due to demand for such equipment the world over. We therefore decided to do it indigenously. We got the machine conceptualized and designed completely in-house and ourselves produced the vital equipment viz. Synthetic Blood Penetration Testing equipment, required for Determination of the resistance of Protective Clothing materials to penetration by blood and body fluids.”.

The Textiles Committee team took almost 45 days of painstaking work to accomplish this feat. The National accreditation body NABL (National Accreditation Board for Testing & Calibration Laboratories) has audited the lab facility and has approved it under three test standards: ASTM F1670/ 16an70M:17a, ISO 16603: 2004 & IS 16546: 2016.

The Secretary informed how the testing equipment will help the nation during the crisis: “With the acquisition of this equipment and with a concrete plan to add some more equipment as per need, we will be able to address not only the quantitative but also the qualitative requirements involved in the testing of Body Coveralls worn by the frontline health workers and other COVID-19 warriors”.

Shri Chavan assured: “As a serious and professional testing organisation with the mandate for quality, we will work overtime to uphold the Textiles Ministry’s directives on quality and would also evolve our own initiatives to further bolster these efforts”.

The Ministry of Textiles, under the leadership of the Textiles Minister Smt. Smriti Zubin Irani, has been taking several steps to ensure that both quality and quantity of PPE coveralls going up to the desired levels within a very short span of time of two months, thereby catapulting India into the world’s second largest manufacturer of body coveralls, next only to China. The Ministry has taken steps to ensure that only certified players across the entire supply chain are allowed to supply body coveralls to governments. Several officials have been posted in the field for onsite facilitation and oversight of quality of material meant for government supplies and for ensuring traceability and ownership of quality by these manufacturers. A Unique Certification Code (UCC) is issued for each passed / cleared prototype sample submitted by the manufacturers of the PPE Coveralls. This is required to be embossed on each manufactured Coverall along with the name of the manufacturer, date of manufacture and name of the client. This procedure has been fully implemented in respect of procurement by M/s HLL Lifecare Limited, which is the procurement agency for the hospitals and healthcare organisations under the Ministry of Health & Family Welfare, Government of India. The manufacturers are also required to submit an affidavit along with their submitted sample, stating details of their manufacturing unit, GSTIN number, company registration number, Udyog Aadhar number or DIC registration number and other relevant details. They are also required to declare that they are textile manufacturers and not traders. The affidavit is to form a part of the UCC Certificate.

Details of all UCC Certificates are available on the official websites of DRDO, OFB (Ordnance Factory Board) and SITRA, for verification by the public.

The eight other labs are: (i) South India Textiles Research Association (SITRA), Coimbatore, Tamil Nadu (ii) DRDO-INMAS, New Delhi, (iii) Heavy Vehicle Factory, Avadi, Chennai (iv) Small Arms Factory, Kanpur, Uttar Pradesh (v) Ordnance Factory, Kanpur, Uttar Pradesh (vi) Ordnance Factory, Muradnagar, Uttar Pradesh (vii) Ordnance Factory, Ambernath, Maharashtra and (viii) Metal & Steel Factory, Ishapore, West Bengal. All these laboratories have been accredited by NABL.

About Textiles Committee

The Textiles Committee is a statutory body established in 1963 through an Act of Parliament and is under the administrative control of the Ministry of Textiles, Government of India. It has been formed to ensure the quality of textiles and textile machinery both for internal consumption and export purpose. The Committee is tasked with the functions of establishing laboratories for the testing of textiles and textile machinery and providing for their inspection and examination, besides other functions which flow from the main objective of ensuring quality of textiles products and textiles machinery.

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