Table 1.
Table showing the required number of sample aliquots for stability testing across various temperature ranges and time intervals.
Table 2.
Homogeneity check of the samples according to the ISO 13528:2022 guidelines.
Table 3.
Stability check of the samples according to the ISO 13528:2022 guidelines.
Table 4.A.
Basic information about the laboratories that participated in the Pilot EQA Programme.
Table 4.B.
Basic information about the laboratories that participated in the Full EQA Programme.
Fig 1.
Geographic distribution of laboratories participating in the full EQA programme.
We obtained the Map of India from the Survey of India portal, Department of Science and Technology (https://indiamaps.gov.in/). Names of the laboratories that participated in the EQA Programme. 1. Regional Medical Research Centre, Dibrugarh, Assam. 2. Gauhati Medical College, Guwahati, Assam. 3. Government Medical College, Agartala, Tripura. 4. Regional Institute of Medical Sciences (RIMS), Imphal, Manipur. 5. Govt Medical College, Srinagar, Jammu & Kashmir. 6. Sher-e-Kashmir Institute of Medical Sciences, Srinagar, Jammu & Kashmir. 7. Dr. Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh. 8. Govt. Medical College, Amritsar, Punjab. 9. Govt. Medical College, Patiala, Punjab. 10. Government Medical College & Hospital, Chandigarh. 11. All India Institute of Medical Sciences (AIIMS) Raipur, Chhattisgarh. 12. Lady Hardinge Medical College, New Delhi. 13. Maulana Azad Medical college, New Delhi. 14. Dr. Ram Manohar Lohia Hospital and Atal Bihari Vajpayee Institute of Medical Sciences, New Delhi. 15. Government Institute of Medical Sciences, Noida, Uttar Pradesh. 16. King George’s Medical University (KGMU), Lucknow, Uttar Pradesh. 17. Dr. Gopal Nath, Banaras Hindu University (BHU), Varanasi, Uttar Pradesh. 18. Regional Medical Research Center, Gorakhpur, Uttar Pradesh. 19. Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, Bihar. 20. MGM Medical College, Jamshedpur, Jharkhand. 21. Rajendra Institute of Medical Sciences (RIMS), Ranchi, Jharkhand. 22. All India Institute of Medical Sciences Bhopal, Madhya Pradesh. 23. National Institute of Research in Tribal Health (NIRTH), Jabalpur, Madhya Pradesh. 24. Kasturba Hospital for Infectious Disease, Mumbai, Maharashtra. 25. Seth G.S Medical college and KEM Hospital, Mumbai, Maharashtra. 26. Government Medical College (GMC), Aurangabad, Maharashtra. 27. Armed Forces Medical College, Pune, Maharashtra. 28. All India Institute of Medical Sciences (AIIMS) Kalyani, West Bengal. 29. ICMR - National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal. 30. North Bengal Medical College, Darjeeling, West Bengal. 31. All India Institute of Medical Sciences (AIIMS) Jodhpur, Rajasthan. 32. Sawai Man Singh (SMS) Medical College, Jaipur, Rajasthan. 33. All India Institute of Medical Sciences Bhubaneswar, Odisha. 34. B.J. Medical College, Ahmedabad, Gujarat. 35. National Institute of Virology (NIV) Field Unit, Alapuzha, Kerala. 36. Osmania Medical College, Hyderabad, Telangana. 37. All India Institute of Medical Sciences, AIIMS Bibinagar (Hyderabad Metropolitan Region), Telangana. 38. Gandhi Medical College, Secunderabad, Telangana. 39. Mysore Medical College & Research Institute, Mysuru, Karnataka. 40. Bangalore Medical College & Research Institute, BMCRI, Bangalore, Karnataka. 41. ICMR- National Institute for Research in Tuberculosis, Chennai, Tamil Nadu. 42. The King Institute of Preventive Medicine and Research (KIPM&R), Chennai, Tamil Nadu. 43. Government Medical College, Theni, Tamil Nadu. 44. Madurai Medical College, Madurai, Tamil Nadu. 45. Tirunelveli Medical College, Tirunelveli, Tamil Nadu. 46. Government Thiruvarur Medical College, Thiruvarur, Tamil Nadu. 47. Govt. Mohan Kumaramangalam Medical College Hospital, Salem, Tamil Nadu. 48. Coimbatore Medical College, Coimbatore, Tamil Nadu. 49. Indira Gandhi Medical College & Research Institute (IGMCRI), Puducherry. 50. Pondicherry Institute of Medical Sciences (PIMS), Puducherry. 51. Sri Venkateshwara, Medical College (SVMCRH), Puducherry.
Table 5.
Performance grading based on qualitative analysis.
Table 6.
The formulae used to compute the statistical parameters.
Table 7.
Statistical analyses of the results reported from laboratories using an InBios ELISA kit.
Table 8.
Statistical analyses of the laboratory results were performed using a J. Mitra ELISA Kit.
Fig 2.
Absorbance values (A) and performance scores—the Q score (B) and Z score(C)—of samples tested by participant laboratories using the InBios ELISA Kit.
Fig 3.
Absorbance values (A) and performance scores—the Q score (B) and Z score (C)—of samples tested by participant laboratories using the J. Mitra ELISA Kit.
Table 9.
Correlations between laboratory data measured by calibrated instruments and corresponding Z scores.