. Author manuscript; available in PMC: 2021 Mar 1.

Published in final edited form as: Eye Contact Lens. 2020 Mar;46(Suppl 2):S84–S105. doi: 10.1097/ICL.0000000000000684

Table 3.

Summary of the Biomarkers’ Analytical and Clinical Validation.

		Analytical Validation		Clinical Validation
Biomarkers	Normal Range	Repeatability/ Intra-observer reliability	Reproducibility/ Inter-observer reliability	Diagnostic		Monitoring	Predictive
Biomarkers	Normal Range	Repeatability/ Intra-observer reliability	Reproducibility/ Inter-observer reliability	Sensitivity	Specificity	Monitoring	Predictive
NIBUT	≥10 seconds	CoV= 7.3-36.6%^18,26,27 ICC= 0.750-0.930^18,23,25-27	CoV= 15.4-21.85%18,²⁷ ICC= 0.880²⁷	80.0-87.0% ^29-31	86.0-100% ^29-31	✔	✔
TMH
• Time Domain	230-332 μm^42,45,51	CoV= 21.3-49.6%^{42,51,292,293}	S_p= ±29μm^36,51	67.0%⁴²	81.0%⁴²	✔
• Spectral Domain	319-354 μm^36,51	CoV= 9.0-28.4%^39,40,51,53 ICC= 0.900-0.981^39,40,51,53	S_p= ±15μm^36,51 CoV= 7.0-17.1%^39,40,51,53 ICC= 0.920-0.930^39,40,51,53	80.5%	89.3%	✔
• Swept-Source	183-339 μm^39,40,51,53	CoV= 23.9-28.0%^48,294 ICC= 0.909-0.981^48,294	CoV= 14.5-28.0%^48,294 ICC= 0.932-0.948^48,294	67.0%	88.0%	✔
TMA
• Time Domain	3,414-35,283 μm^{2 15,39,48-50}					✔
• Spectral Domain	25,383-62,100 μm2 ^15,39,48-50	CoV = 17.0-44.0%^53,54,292	CoV = 19.5-35.4%^53,54,292	86.1%	85.3%	✔
• Swept-Source	12,459-27,900 μm^{2 15,39,48-50}	CoV= 45.5-52.0%^48,294 ICC= 0.873-0.990^48,294	CoV= 27.7-29.4%^48,294 ICC=0.813-0.982^48,294	62.0%	92.0%	✔

NIBUT: non-invasive tear break-up time, TMH: tear meniscus height, TMA: tear meaniscus area, Sp= pooled standard deviation, CoV: coefficient of variability, ICC: intra- or inter-class correlation coefficient.