Table 2.

Validation of indigenously developed diagnostics

Dx	Syndrome targeted	Survey*	Analytical/performance parameter tested	Stability of product tested	Evidence on scalability	Evaluation of cost effectiveness	Technology readiness level (TRL)†
1	Sepsis	I	Sensitivity, LoD, LoQ, PPV, specificity, NPV, accuracy	No	No	No	TRL 4
		II	No additional parameter tested	No	No	No	TRL 4
2	Sepsis	I	Sensitivity, LoQ, specificity, NPV, PPV, accuracy, reproducibility	Yes, 6 months at room temperature	No	No	TRL 5
		II	Shelf-life and shipping stability were evaluated Scoring algorithm added	Same as in survey I	Yes	No	TRL 7
3	Bacteraemia	I	Sensitivity, LoD	No	No	No	TRL 4
		II	No additional parameter tested	No	No	No‡	TRL 4
4	Urinary tract infection	I	Sensitivity, LoD, LoQ, PPV, specificity, NPV, accuracy, linearity, reproducibility	Yes, 1 year at 4°C	No	No	TRL 7
		II	No additional parameter tested	Same as in survey I	Yes	No‡	TRL 8
5	Identification of Pathogen and resistance markers	I	No information provided	Yes, 1 month	No	No	TRL 4
		II	Calorimetric format developed	Same as in survey I	No	No‡	TRL 6
6	Urinary tract infection	I	Sensitivity, LoD, reproducibility	No	No	No	TRL 5
		II	No additional parameter tested	Yes, details not provided	No	No	TRL 6
7	Pulmonary, pleural tuberculosis (TB), TB meningitis	I	Sensitivity, LoD, PPV, NPV, specificity, accuracy, linearity, reproducibility	Yes, 6 months	No	No	TRL 5
		II	Details not provided	Same as in survey I	Yes	No	TRL 6
8	TB	I	Sensitivity, LoD, NPV, specificity, reproducibility	Yes,	No	No	TRL 6
		II	Shelf-life evaluated	Same as in survey I	Yes	No‡	TRL 7

Green colour box indicates the progress made in particular characteristic in survey II.

*Two surveys were conducted in January 2019 (survey I) and in January 2021 (survey II) to collect the data.

†TRL has been refereed as per the criteria mentioned by Biotechnology Industry Research Assistance Council, Department of Biotechnology, Government of India for medical devices including diagnostic devices and for in vitro diagnostic kits and reagents.¹⁸ Available from https://www.birac.nic.in/webcontent/birac_trl_doc5_medical_devices_and_diagnosis_12_09_2018.pdf.

‡The cost per test has been estimated for the diagnostic based on the cost of raw materials but cost-effectiveness study was not performed.

LoD, limit of detection; LoQ, limit of quantitation; NPV, negative predictive value; PPV, positive predictive value.