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 Table of Contents 
ORIGINAL ARTICLE
Year : 2019  |  Volume : 8  |  Issue : 1  |  Page : 184-188  

Diagnosis and treatment of pulmonary tuberculosis in one day : Way forward for END TB Strategy 2015


1 Department of Pulmonary Medicine, ADK Hospital, Male, Maldives
2 Department of Pulmonary Medicine, S.C.B. Medical College, Cuttack, Odisha, India

Date of Web Publication31-Jan-2019

Correspondence Address:
Dr. Gourahari Pradhan
Consultant, Department of Pulmonary Medicine, ADK Hospital, Male
Maldives
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jfmpc.jfmpc_358_16

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  Abstract 


Background: According to Revised National Tuberculosis Control Program (RNTCP), diagnosis of pulmonary tuberculosis (TB) in India requires examination of two sputum samples collected over 2 days, that is, “spot” and next day “morning” samples. Objective: To assess the feasibility of diagnosing pulmonary TB by examining two spot sputum samples in 1 day and to compare this approach with the current RNTCP protocol. Materials and Method: A total of 375 subjects having cough >2 weeks were enrolled into the study. Three sputum samples were collected from each of the study participant; first spot (S1), second extra-spot (S2) sample 1 h after collection of the first sample, and third morning (M) sample collected next day morning. These specimens were subjected to standard sputum smear microscopy for acid-fast bacilli as per RNTCP guidelines. For 1-day protocol, results of “S1 and S2” samples and for 2-day protocol results of “S1 and M” samples were considered. Results: The number of sputum-positive pulmonary TB cases diagnosed with standard 2-day protocol was 119, whereas the experimental 1-day protocol diagnosed 120 cases (P = 0.7). Comparing with standard 2-day protocol, this new 1-day protocol had sensitivity 98.32%, specificity 100%, positive predictive value 100%, and negative predictive value 99.17%. Conclusion: Single-day method can be adopted as the standard diagnostic approach for pulmonary TB after large-scale multicenter randomized controlled trials.

Keywords: Acid-fast bacillus, Mycobacterium tuberculosis, pulmonary tuberculosis, sputum microscopy, Ziehl–Neelsen stain


How to cite this article:
Pradhan G, Pattnaik M, Sethy HK, Patnaik J, Mohanty T, Giri PK. Diagnosis and treatment of pulmonary tuberculosis in one day : Way forward for END TB Strategy 2015. J Family Med Prim Care 2019;8:184-8

How to cite this URL:
Pradhan G, Pattnaik M, Sethy HK, Patnaik J, Mohanty T, Giri PK. Diagnosis and treatment of pulmonary tuberculosis in one day : Way forward for END TB Strategy 2015. J Family Med Prim Care [serial online] 2019 [cited 2019 Feb 20];8:184-8. Available from: http://www.jfmpc.com/text.asp?2019/8/1/184/251171




  Introduction Top


Diagnosis of pulmonary tuberculosis (TB) in low-income, high-burden countries often relies on direct sputum smear microscopy for acid-fast bacillus (AFB). Since the policy change in Revised National Tuberculosis Control Program (RNTCP) in April 2009, diagnosis of pulmonary TB in India requires smear microscopy examination of two sputum samples: one spot and another morning sample, switching from earlier three sputum sample collection over 2 days.[1] From TB program point of view, this approach saves time and cost while providing similar diagnostic efficacy.[2],[3],[4],[5] However, the patients still have to come to health center on 2 consecutive days; the time and economic savings for the patient appears negligible.[6] World Health Organization (WHO) in its policy statement of May 2011 has advocated for implementation of single-day approach for diagnosis of pulmonary TB in countries which have successfully implemented the two sputum specimens' case finding strategy, especially in settings where patients are likely to default from diagnostic process.[7] This study was conducted with an objective to assess the feasibility of diagnosing pulmonary TB by examining two spot sputum samples in 1 day and to compare this approach with the current RNTCP protocol.


  Materials and Methods Top


This study was conducted in the Department of Pulmonary Medicine, SCB Medical College, between September 2010 and August 2012. It was a cross-sectional study. Patients attending the outpatient department with cough for more than 2 weeks were recruited into the study. The study participants included referred patients from different primary health centers and patients coming directly to this hospital. Accordingly, the duration of cough varied from minimum requisite for this study 2 weeks to maximum 40 weeks. They were informed about the nature of the study in their own language and a verbal consent was taken. Those who had previously taken antitubercular therapy for more than 1 month and those who did not give consent were excluded from the study. A detailed clinical history was taken followed by thorough clinical examination for each study participant. Routine blood investigations and chest X-rays were done to study the clinical–radiological–microbiological associations. Subsequently, they were asked to collect and submit three sputum samples: first a spot sample (S1), second an extra-spot sample (S2) collected 1 h after the first sample, and the third sample (M) collected on the next day early morning. To ensure optimum sample quality, the method of sputum collection was demonstrated to the study participants by a trained personnel with the aid of visual display board and written instructions whenever necessary. Spot samples were collected under the direct supervision of the laboratory technicians. When the patients coughed up only saliva or did not produce at least 2 ml of sputum, they were encouraged to give another better specimen. The smear preparation, Ziehl–Neelsen (ZN) staining, and microscopy were done according to RNTCP guidelines, but in a blinded manner by the RNTCP-trained technician. The three sputum samples collected from each study participant were given a random code. The microscopy technician and the researchers were unaware which sample belonged to which subject. Any one sample positive for AFB was considered as a case of pulmonary TB. The performance of 1-day protocol was assessed by the results of spot (S1) and extra-spot (S2) samples and the 2-day protocol was assessed with the results of spot (S1) and morning (M) samples. Data were entered and analyzed in Epi Info version 2007. Categorical variables were expressed regarding numbers and proportions. Chi-square test was used for showing an association. P < 0.05 was considered significant.


  Results Top


The total number of study participants was 375. The majority (74.7%) were males (M: F = 2.95:1). The maximum number of patients (40.6%) belonged to the age group 21–40 years. About 60.8% of the subjects belonged to below poverty line category. The total number of spot and extra-spot samples collected was 375 each. In all, 18 of these 375 patients defaulted in submission of next day morning samples, that is, the total number of morning sputum samples collected was 357. Flow of patients and study protocol are depicted in the flowchart [Figure 1]. The number of sputum AFB-positive samples was 120 in spot (S1), 110 in extra-spot (S2), and 119 in morning (M) sample. The total number of smear-positive pulmonary TB cases in the study was 123 considering the results of all three samples. The number of smear-positive pulmonary TB patients diagnosed on 1-day (S1 and S2) protocol was 120. The number of new smear-positive cases detected in morning samples which were smear-negative in 1-day protocol were only 2, that is, 1-day protocol missed 1.6% of cases. Whereas 3 of the 18 dropped out patients were sputum-positive for AFB in the first spot sample. The conventional 2-day protocol diagnosed 119 (96.75%), while the experimental 1-day protocol diagnosed 120 (97.56%) of all smear-positive TB patients [Table 1]. Chi-square test was applied for comparison between the two protocols [Table 2]. P- value was 0.7, which implies that there is no statistical difference between these two diagnostic protocols. Gold standard investigation for diagnosis of pulmonary TB is sputum culture, but in program setting 2-day spot-morning method is considered as standard approach. When the new 1-day method was compared against 2-day method as gold standard [Table 3], it had sensitivity 98.32%, specificity 100%, positive predictive value 100%, and negative predictive value 99.17%.
Figure 1: Patients flowchart

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Table 1: Comparison of diagnostic efficacy of 1-day vs 2-day protocol

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Table 2: Comparison of 1-day vs 2-day protocol

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Table 3: Diagnostic validity of 1-day protocol against standard 2-day protocol

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  Discussion Top


Till date, WHO recommends sputum microscopy for diagnosis of pulmonary TB. Due to low sensitivity of this investigation, the number of sputum samples required to be tested to achieve satisfactory diagnostic yield was a matter of intense research.[8] Many countries adopted a spot-morning-spot sputum sample strategies in national TB control programmes. After many studies including those from India, it was stated in WHO 2007 document that approximately 85.8% of patients were diagnosed with first sputum sample. Incremental yield of second sample was 11.9% and that of third sample was only 3.1%.[8],[9] WHO recommended that examination of two sputum samples may suffice in countries with established quality control measures for laboratories. The diagnostic yield of morning sputum sample was higher compared to spot samples, and hence RNTCP India adopted Spot-Morning sputum sample strategy.[8] The advantages and disadvantages of three schemes, that is, “Spot-Morning-Spot,” “Spot-Morning,” and “Spot-ExtraSpot” are discussed in [Table 4]. The “END TB Strategy” proposed by WHO with a goal to end the “global tuberculosis epidemic” by the year 2035 has set the targets of reduction of TB deaths by 95% and reduction of TB incidence rate by 90% compared to 2015. Financial protection to TB-affected families is a new target of “END TB Strategy” so that “No TB affected families should face catastrophic financial loss due to TB by 2020.[10] With the current RNTCP protocol, patients have to come to the health facility on two consecutive days for sputum sample submission. Almost always the patients are accompanied by an adult attendant during these hospital visits. The cost of the diagnostic process for the patient includes transport, accommodation, food for at least two persons, and clinic cost whenever applicable which may include laboratory investigations, X-rays, and so on. According to a study conducted in Nepal and Yemen, this cost accounts for approximately 1 week's per capita income in these countries.[11] Excluding the clinic cost, the remaining expenditure gets doubled for a 2-day protocol compared to 1-day protocol. More importantly, there is contributory hidden cost related to loss of income due to these hospital visits. These are expected to be the major factors responsible for patients dropping out of the diagnostic process.[12],[13],[14] The anticipated number of TB cases worldwide in 2014 was 9.6 million, but only 6 million cases were reported to WHO, that is, only 64% of the anticipated number of cases were reported; 36% of cases were either undiagnosed or not reported.[15] This reflects a gap in reporting and access to healthcare. Ten countries account for 74% or 2.4 millions missed TB cases globally and India tops the list contributing to 27% of these cases.[16] The longer it takes to diagnose and start treatment, an undiagnosed sputum-positive pulmonary TB patient keeps on transmitting the infective organism to others during transport, repeated hospital visits, and during the stay in various places of accommodation. If the diagnostic process can be completed in 1 day and treatment started on the same day itself, these issues of providing financial protection to patients, reducing the dropout rates from diagnostic process or finding the missed cases of TB, and breaking the chain of infection transmission can be addressed.
Table 4: Comparison of different diagnostic strategies

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In this study, the single-day approach was found to have similar diagnostic accuracy as the current RNTCP 2-day protocol for diagnosis of TB. Similar studies done in the past with their primary results are given in [Table 5].[17],[18],[19],[20],[21],[22],[23],[24],[25] Seven of the nine studies had results similar to our study and recommended 1-day approach for diagnosis of pulmonary TB.
Table 5: Findings of earlier studies on 1.day smear microscopy method

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  Conclusion Top


One-day protocol for diagnosis of pulmonary TB has equal diagnostic efficacy as standard 2-day protocol and it can be adopted as the standard diagnostic approach under RNTCP after multicentric large-scale studies.

Limitations of the study

The limitations of the study are as follows:

  1. Sample size was small
  2. It was not a multicentric study
  3. Smear-positive cases could not be confirmed by culture.


Financial support and sponsorship

RNTCP, India.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Changes in RNTCP policy on diagnosis of smear positive pulmonary TB: TB INDIA 2009 RNTCP status report. p. 73. Available from: http://tbcindia.nic.in/showfile.php?lid=2921. [Cited on 2015 Dec 15].  Back to cited text no. 1
    
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Thomas A, Chandrasekaran V, Joseph P, Rao VB, Patil AB, Jain DK,et al. Increased yield of smear positive pulmonary TB cases by screening patients with > or = 2 weeks cough, compared to >or=3 weeks and adequacy of 2 sputum smear examinations for diagnosis. Indian J Tuberc 2008;55:77-83.  Back to cited text no. 2
    
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Gopi PG, Subramani R, Selvakumar N, Santha T, Eusuff SI, Narayanan PR. Smear examination of two specimens for diagnosis of pulmonary tuberculosis in Tiruvallur District, south India. Int J Tuberc Lung Dis 2004;8:824-8.  Back to cited text no. 3
    
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Sarin R, Mukerjee S, Singla N, Sharma PP. Diagnosis of tuberculosis under RNTCP: Examination of two or three sputum specimens. Indian J Tuberc 2001;48:13-16.  Back to cited text no. 4
    
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Harries AD, Mphasa NB, Mundy C, Banerjee A, Kwanjana JH, Salaniponi FM. Screening tuberculosis suspects using two sputum smears. Int J Tuberc Lung Dis 2000;4:36-40.  Back to cited text no. 5
    
6.
Yassin MA, Cuevas LE. How many sputum smears are necessary for case finding in pulmonary tuberculosis? Trop Med Int Health 2003;8:927-32.  Back to cited text no. 6
    
7.
Same-day diagnosis of tuberculosis by microscopy: WHO policy statement, 2011 WHO/HTM/TB/2011.7 16 pages. Available from: http://www.who.int/tb/publications/2011/tb_microscopy_9789241501606/en/. [Cited on 2015 Dec 15].  Back to cited text no. 7
    
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Sarin R, Mukerjee S, Singla N, Sharma PP. Diagnosis of tuberculosis under RNTCP: Examination of two or three sputum specimen. Ind J Tub 2001;48:13-6.  Back to cited text no. 8
    
9.
TB diagnostics and laboratory strengthening – WHO policy. Reduction of number of smears for the diagnosis of pulmonary TB, 2007. Available from: www.who.int/tb/laboratory/policy_diagnosis_pulmonary_tb/en/. [Last accessed on 2016 Dec 20].  Back to cited text no. 9
    
10.
The END TB Strategy; WHO, Global strategy and targets for tuberculosis prevention, care and control after 2015. Available from: http://www.who.int/tb/post2015_strategy/en/. [Cited on 2015 Dec 15].  Back to cited text no. 10
    
11.
Ramsay A, Al-Aghbari N, Sherchand J, Jeevan SB, Al-Sonboli N, Almotowa A,et al. Direct patient costs associated with the diagnosis of tuberculosis in urban and rural population in Yemen and Nepal. Int J Tuberc Lung Dis 2010;14:50-8.  Back to cited text no. 11
    
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Squire SB, Belaye AK, Kashoti A, Salaniponi FM, Mundy CJ, Theobald S,et al. “Lost” smear-positive pulmonary tuberculosis cases: Where are they and why did we lose them? Int J Tuberc Lung Dis 2005;9:25-31.  Back to cited text no. 12
    
13.
Sai Babu B, Satyanarayana AV, Venkateshwaralu G, Ramakrishna U, Vikram P, Sahu S,et al. Initial default among diagnosed sputum smear-positive pulmonary tuberculosis patients in Andhra Pradesh, India. Int J Tuberc Lung Dis 2008;12:1055-8.  Back to cited text no. 13
    
14.
Botha E, den Boon S, Lawrence KA, Reuter H, Verver S, Lombard CJ,et al. From suspects to patient: Tuberculosis diagnosis and treatment initiation in health facilities in South Africa. Int J Tuberc Lung Dis 2008;12:936-41.  Back to cited text no. 14
    
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Global Tuberculosis Report 2015; WHO. Available from: http://www.who.int/tb/publications/global_report/en/. [Cited on 2015 Dec 15].  Back to cited text no. 15
    
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Global Tuberculosis Report 2014;WHO. Chapter 3- Countdown to 2015; p. 52.  Back to cited text no. 16
    
17.
Rawat J, Biswas D, Sindhwani G, Masih V. An alternative 1-day smear microscopy protocol for the diagnosis of pulmonary tuberculosis. Respirology 2010;15:1127-30.  Back to cited text no. 17
    
18.
Hirao S, Yassin MA, Khamofu HG, Lawson L, Cambanis A, Ramsay A,et al. Same-day smears in the diagnosis of tuberculosis. Trop Med Int Health 2007;12:1459-63.  Back to cited text no. 18
    
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Cambanis A, Yassin MA, Ramsay A, Squire SB, Arbide I, Cuveas LE. A one-day method for the diagnosis of pulmonary tuberculosis in rural Ethiopia. Int J Tuberc Lung Dis 2006;10:230-2.  Back to cited text no. 19
    
20.
Anyim M, Aguwa EN, Chukwu JN. One-day 2 sputum samples AFB microscopy versus standard two-day 3 sputum samples AFB microscopy in a Nigerian rural tuberculosis center. J Coll Med 2008;13:101-4.  Back to cited text no. 20
    
21.
Miremba P, Kalyango JN, Worodria W, Mugerwa H, Nakakawa E, Asiimwe BB. Performance of frontloading for smear microscopy in the diagnosis of pulmonary tuberculosis: A cross-sectional study at a referral hospital in Uganda. PLoS ONE 2012;7:e48531.  Back to cited text no. 21
    
22.
Chandra TJ, Raj RS, Sharma YV. Same day sputum smear microscopy approach with modified ZN staining for the diagnosis of pulmonary tuberculosis in a microscopy centre at Rajahmundry. Indian J Med Microbiol 2014;32:153-6.  Back to cited text no. 22
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23.
Chandra TJ, Selvaraj R, Sharma YV. Same-day sputum smear microscopy for the diagnosis of pulmonary tuberculosis: Direct vs. concentrated smear. Int J Tuberc Lung Dis 2016;20:247-51.  Back to cited text no. 23
    
24.
Nayak P, Kumar AMV, Claassens M, Enarson DA, Satyanarayana S, Kundu D,et al. Comparing same day sputum microscopy with conventional sputum microscopy for the diagnosis of tuberculosis – Chhattisgarh, India. PLoS ONE 2013;8:e74964.  Back to cited text no. 24
    
25.
Myneedu VP, Verma AK, Sharma PP, Behera D. A pilot study of same day sputum smear examination, its feasibility and usefulness in diagnosis of pulmonary tuberculosis. Indian J Tuberc 2011;58:160-7.  Back to cited text no. 25
    


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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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