Table 1.

Characteristics of indigenously developed rapid diagnostics (Dx) for pathogen identification and antimicrobial susceptibility

Characteristics	Diagnostic (Dx)
	Dx 1	Dx 2	Dx 3	Dx 4	Dx 5	Dx 6	Dx 7	Dx 8
Syndrome targeted	Sepsis (bacteraemia detection)	Sepsis	Bacteraemia	Urinary tract infection (UTI)	Identification of Pathogen and resistance markers	Urinary Tract Infection	Pulmonary and pleural tuberculosis (TB), TB meningitis	TB
Level of healthcare (HC) targeted	Primary HC, general practitioner, hospitals,	Primary HC, general practitioner,	Primary HC, general practitioner,	Primary HC, general practitioner, Hospitals	Primary HC, general practitioner,	Primary HC, general practitioner,	Primary HC, general practitioner,	Microscopy technicians in the DOTS centre
Sample type used	Plasma, serum	Saliva	Blood	Urine	Blood, urine	Urine	Cerebrospinal fluid, pleural fluid and sputum	Sputum
Pathogen targeted	Gram-positive and gram-negative bacteria	NA (detect biomarkers)	Salmonella Typhi	Escherichia coli, Klebsiella, Enterococcus, Staphylococcus, Pseudomonas, Proteus	Gram negative: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii Gram positive: Enterococcus spp, Staphylococcus aureus	Escherichia coli, Klebsiella, Pseudomonas aeruginosa, Enterococci	NA (detect antigens)	Mycobacterium tuberculosis (MTB)
Antibiotics or genes tested	Nil	NA	Cephalosporin Piperacillin Imipenem Cefotaxime Ceftriaxone	A customisable and prefunctionalised panel of 42 antibiotics;	A customisable panel of resistance markers: NDM, KPC, VIM, IMP, OXA-48 family, OXA-58, OXA-23;	Nil	Nil	Nil
Output type	Colorimetric; semiquantitative	Quantitative	Qualitative and quantitative	Colorimetric and nephlometric	Qualitative	Qualitative	Qualitative and quantitative	Qualitative
Hands-on-time	10–15 min	3 min	5 min	20 min	~10 min	2–3 min	No information shared by developer	15 min
Turnaround time (TAT)	5 min	2 min	5 hours for bacterial identification and 2 hours for AST	4 hours for105 bacterial per mL	2–3 hours	20 min	5 hours	1 hour
Control/ reference method used	White Blood Cells count; procalcitonin, culture, ELISA	Quantitative blood CRP	Blood culture and VITEK	Kirby Bauer VITEK	Culture method	Culture method; Urine dipsticks	No information shared by developer	GeneXpert, MGIT liquid culture;
Clinical validation of test*	Yes, 150 clinical samples	Yes, 100 samples	No	Yes, 2324 samples	Yes, 300 patients	Yes, 500 patients	No	Yes, tested at a DOTS centre but details of sample size not provided
Strength	Rapid detection of gram positive and gram negatives in sepsis	Potential of good clinical utility for rapid diagnosis of neonatal sepsis, and use of low sample volume (~40 µL)	Potential of good clinical utility for rapid diagnosis of bacteraemia (eg, Salmonella)	Rapid quantitative detection of UTI pathogens, ready-to-use antibiogram, No need for accessory equipment	Clinically promising for rapid detection of bacteraemia, UTI and sepsis, and culture free identification of common bacterial pathogens	Rapid and point of care test to detect four common uropathogens in a single test	Rapid qualitative and quantitative detection of TB antigen, pulmonary and pleural TB and TB meningitis	Useful in converting a bright field microscope into a fluorescence microscope which can improve the outcome of smear-based microscopic analysis, and promising for resource limited settings
Weakness†	Does not test antibacterial sensitivity or detect resistant genes, Does not detect fungal pathogens causing sepsis like Candida	Few aspects such as effect of milk contamination, dehydration, etc need to be addressed	Does not detect resistant genes, Targets only bacteria, Field feasibility in hospital wards or non-laboratory locations need to be ascertained	Does not detect priority pathogens like Candida, Enterobacter, Acinetobacter, Low probability of not detecting pathogen if bacterial load is less than 102 cells/mL	Does not detect Candida, Streptococcus pneumoniae	Does not test antibacterial sensitivity or detect resistant genes, Does not detect Candida	Does not detect AST, Not suitable for the detection of TB from tissue samples, May not detect infections of Mycobacterium other than TB	High TAT, Does not differentiate non-TB mycobacteria from MTB

*For understanding the extent of validation of diagnostic undertaken by developer, details were sought on samples tested and population, control/reference method used and analytical parameters that had been evaluated. Details of analytical parameters that have been evaluated was sought qualitatively as ‘yes’ or ‘no’ to ensure the data confidentiality.

†All diagnostic tests need to undergo field feasibility and cost-effectiveness studies.

AST, antibiotic sensitivity testing; CRP, C reactive protein; DOTS, directly observed therapy, short course; IMP, imipenemase; KPC, Klebsiella pneumoniae carbapenemase; LoD, limit of detection; MGIT, mycobacterial growth indicator tube; NA, not applicable; NDM, New Delhi metallo-β-lactamase; NPV, negative predictive value; OXA, oxacillinase; PPV, positive predictive value; VIM, Verona- intergon-encoded metallo-β-lactamase.