Abstract

BackgroundLight-emitting diode fluorescence microscopy (LED-FM) has been shown to be more sensitive than conventional bright field microscopy using Ziehl-Neelsen (ZN) stain in detecting sputum smear positive tuberculosis in controlled laboratory conditions. In 2012, Auramine O staining based LED-FM replaced conventional ZN microscopy in 200 designated microscopy centres (DMC) of medical colleges operating in collaboration with India’s Revised National Tuberculosis Control Programme. We aimed to assess the impact of introduction of LED-FM services on sputum smear positive case detection under program conditions.MethodsThis was a before and after comparison study. In 15 randomly selected medical college DMCs, all presumptive TB patients who underwent sputum smear examination in the years 2011 (before LED-FM) and 2012 (after LED-FM) were compared. An additional 15 comparable DMCs that implemented conventional ZN sputum smear microscopy were also selected for comparison between 2011 and 2012.ResultsThe proportion of presumptive TB patients (PTP)found sputum smear positive increased by 30%- from 13.6% (3432/25159) in 2011 to 17.8% (4706/26426) in 2012 (P value <0.01) in the sites that implemented LED-FM microscopy, whereas in DMCs where the ZN staining procedure is followed the proportion of sputum smear positive had remained unchanged (13.0%versus 12.6%;P value0.31).ConclusionUse of LED-FM significantly increased the proportion of smear positive cases among presumptive TB patients under routine program conditions in high workload laboratories. The study provides operational evidence needed to scale-up the use of LED-FM in similar settings in India and beyond.

Highlights

  • Light-Emitting Diode Fluorescence Microscopy (LED-FM) for sputum smear examination is recommended by the World Health Organization (WHO) for detection of acid-fast bacilli in high tuberculosis (TB) burden countries [1]

  • In India, [6] medical colleges have tertiary care hospitals functioning in close collaboration with Revised National Tuberculosis Control Programme (RNTCP) for TB care and control

  • The training module of RNTCP for fluorescence microscopy was revised by a technical working group consisting members from National TB Reference Laboratories (NRL) and Intermediate TB Reference Laboratories (IRL), Central TB Division (CTD), WHO, FIND, and The Union and was approved by CTD

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Summary

Introduction

Light-Emitting Diode Fluorescence Microscopy (LED-FM) for sputum smear examination is recommended by the World Health Organization (WHO) for detection of acid-fast bacilli in high tuberculosis (TB) burden countries [1]. In India (high TB burden country), [6] medical colleges have tertiary care hospitals functioning in close collaboration with Revised National Tuberculosis Control Programme (RNTCP) for TB care and control. These hospitals have RNTCPs designated microscopy centre (DMC) for the diagnosis of sputum smear positive pulmonary TB using ZN stain based bright field microscopy. Light-emitting diode fluorescence microscopy (LED-FM) has been shown to be more sensitive than conventional bright field microscopy using Ziehl-Neelsen (ZN) stain in detecting sputum smear positive tuberculosis in controlled laboratory conditions. We aimed to assess the impact of introduction of LED-FM services on sputum smear positive case detection under program conditions

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