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Article History

Received: 27 March 2020

Accepted: 16 November 2020

First Online: 23 November 2020

Competing interest

: Parag Dharap has been a Medical Evaluator for HORIBA Medical since 2018. Sebastien Raimbault is an employee of HORIBA Medical.

: This study, registered as reference IEC / 19 / 01, has received approval on 6th June 2019 for retrospective analysis from INDEPENDENT ETHICS COMMITTEE (IEC), Reg No. 1433 / 1999 G.B.B.S.D., ETHICS COMMITTEE REGISTRATION No. ECR / 196 / Indt / MH / 2014 issued under Rule 122 DD of Drugs & Cosmetics Rule 1945. Waiver of Informed consent had been requested and has been granted as protocol was meeting the following criteria: The research presents no more than “minimal risk” of harm to subjects. The waiver or alteration will not adversely affect the rights and welfare of the subjects. The research could not practicably be carried out without the waiver or alteration. The results of instrument generated suspect flags, though indicate the possibility of existence of an abnormality, are only for the technical assistance of laboratory personnel & are never directly conveyed to the clinician or patient without verification. Therefore, they do not have impact on the referring clinician’s judgment or on the patient's state of mind.

: Not applicable.