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PLOS Glob Public Health
PLOS Glob Public Health
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PLOS Global Public Health
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Public Library of Science San Francisco, CA USA

10.1371/journal.pgph.0003652
PGPH-D-24-01529
Research Article
Medicine and Health Sciences
Medical Conditions
Infectious Diseases
Bacterial Diseases
Tuberculosis
Medicine and Health Sciences
Medical Conditions
Tropical Diseases
Tuberculosis
Medicine and Health Sciences
Diagnostic Medicine
Tuberculosis Diagnosis and Management
Biology and Life Sciences
Organisms
Bacteria
Actinobacteria
Mycobacterium Tuberculosis
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Africa
Nigeria
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Research and analysis methods
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DNA extraction
Biology and Life Sciences
Molecular Biology
Molecular Biology Techniques
Artificial Gene Amplification and Extension
Polymerase Chain Reaction
Research and Analysis Methods
Molecular Biology Techniques
Artificial Gene Amplification and Extension
Polymerase Chain Reaction
Perceived ease of use of Truenat among laboratory staff as a new diagnostic tool for TB in Nigeria: Result of a pilot roll-out
Ease of use of Truenat
https://orcid.org/0000-0002-1739-6350
Ihesie Austin Conceptualization Data curation Funding acquisition Investigation Methodology Project administration Resources Supervision Writing – original draft Writing – review & editing 1
Nwokoye Nkiru Conceptualization Data curation Investigation Methodology Project administration Resources Supervision Writing – original draft Writing – review & editing 2
Olabamiji Jamiu Conceptualization Data curation Investigation Methodology Project administration Resources Supervision Writing – original draft Writing – review & editing 3
Ochei Kingsley Conceptualization Data curation Investigation Methodology Project administration Resources Supervision Writing – original draft Writing – review & editing 4
https://orcid.org/0000-0002-3616-7457
Eneogu Rupert Conceptualization Funding acquisition Investigation Project administration Resources Supervision Writing – review & editing 1
Nongo Debby Project administration Resources Software Supervision Visualization Writing – review & editing 1
Babayi Aminu Project administration Resources Software Supervision Writing – review & editing 2
Olugbemiga Rayi Project administration Resources Software Supervision Writing – review & editing 3
Odume Bethrand Investigation Project administration Resources Software Supervision Visualization Writing – review & editing 2
Agbaje Aderonke Investigation Project administration Resources Software Supervision Writing – review & editing 3
Oyelaran Omosalewa Investigation Project administration Resources Supervision Writing – review & editing 1
van Germert Wayne Resources Software Supervision Visualization Writing – review & editing 5
https://orcid.org/0000-0002-2290-2481
Mupfumi Lucy Investigation Resources Software Writing – review & editing 5
Amos Omoniyi Investigation Resources Software Visualization Writing – review & editing 6
Emeka Elom Investigation Resources Software Supervision Writing – review & editing 7
Anyaike Chukwuma Investigation Resources Software Supervision Writing – review & editing 7
https://orcid.org/0000-0002-4098-4898
Ossai Edmund Ndudi Conceptualization Data curation Formal analysis Methodology Supervision Writing – original draft Writing – review & editing 8 *
1 HIV AIDS & TB Office, USAID Nigeria, Abuja, Nigeria
2 KNCV Nigeria, Abuja, Nigeria
3 IHV-Nigeria, Lagos, Nigeria
4 USAID Leap Project, Abuja, Nigeria
5 STOP TB Partnership, Geneva, Switzerland
6 World Health Organization, Abuja, Nigeria
7 Federal Ministry of Health, Abuja, Nigeria
8 Department of Community Medicine, College of Health Sciences, Ebonyi State University Abakaliki, Abakaliki, Nigeria
Rajendran Priya Editor
ICMR-National Institute for Research in Tuberculosis: National Institute of Research in Tuberculosis, INDIA
The authors have declared that no competing interest exist.

* E-mail: ossai_2@yahoo.co.uk
20 9 2024
2024
4 9 e00036521 7 2024
8 8 2024
https://creativecommons.org/publicdomain/zero/1.0/ This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

In January 2020, WHO released a rapid communication on use of molecular assays as initial tests for diagnosis of tuberculosis, recommending Truenat as a replacement for smear microscopy in TB diagnosis. This study was designed to assess perceived ease of use of Truenat among Laboratory staff as a new diagnostic tool for TB in Nigeria. This study used a cross-sectional design. All trained Laboratory personnel operating the Truenat Duo equipment in 38 Truenat sites in the country were included. Information was obtained using a pre-tested self-administered questionnaire. Ease of use of Truenat was assessed using twenty-three variables on a five-point Likert scale of 1–5. The variables were analyzed quantitatively and qualitatively. Good Ease of use of Truenat was determined by proportion of respondents who answered ≥70% of the variables in the positive. All 50 Truenat Laboratory staff participated in the study. (Response rate 100%). Majority, (58%) were male. The median estimated number of tests before Laboratory staff became proficient with Truenat machine was 9 (IQR, 4–20), median number of tests to be analyzed within eight working hours was 10, (IQR = 8–15) and median time to conduct a Truelab MTBPlus test from start to finish was 60 minutes (IQR = 60–80). The commonest operational challenge that required Molbio service support was Trueprep errors/blockage, 47.4%. Overall, mean ease of use score was 4.0±0.4. Majority, (76%) had Good Ease of use of Truenat. No factor significantly influenced Ease of use of Truenat. Truenat machine is easy to use for a trained laboratory staff with minimal technical support and hence could be rolled out easily and successfully by various National TB Programs. Considering the high Trueprep challenges reported, there is need for further studies into the common errors/challenges, the contexts surrounding them and the programmatic intervention to address the high rate of Trueprep equipment faults.

USAID through STOP TB Partnership https://orcid.org/0000-0002-1739-6350
Ihesie Austin The study was funded by the United States Agency for International Development (USAID) through the Stop TB partnership introducing new tools project (iNTP). The USAID Country Team in Nigeria was involved in the design and implementation of the study and in producing the manuscript. However, the views as expressed in the manuscript do not represent that of USAID. Data AvailabilityThe datasets used and/or analyzed during this study are within the paper and its Supporting Information files.
Data Availability

The datasets used and/or analyzed during this study are within the paper and its Supporting Information files.
==== Body
pmcIntroduction

Globally, an estimated 10.6 million people fell in with tuberculosis (TB) in the year 2021. This reveals an increase of 4.5% over the 2020 estimate of 10.1 million people. Additionally, the burden of drug-resistant TB (DR-TB) also increased within the same period with the diagnosis of 450,000 new cases of Rifampicin resistant TB in 2021 [1]. Similarly, the number of deaths associated with tuberculosis increased from an estimated 1.4 million deaths in 2020 to 1.6 million in 2021 [1]. The COVID-19 pandemic resulted in a large global fall in the number of people newly diagnosed with TB and notified in the year 2020 compared with the figures of 2019. Suffice it to say that COVID-19 pandemic had a negative effect on access to TB diagnosis and treatment and the burden of TB disease globally in 2021 [1].

In Nigeria, although the COVID-19 pandemic affected efficient TB program implementation, the country was among four countries worldwide that experienced an increase in TB case finding within the period of the COVID-19 pandemic [2]. Notwithstanding, TB diagnosis remains a challenge in Nigeria as the country accounts for 4.6% of the global TB burden. The country is also one of the ten countries that contributes to the highest burden of missing TB cases globally and also has a high triple burden of TB, DR-TB and HIV associated TB [3].

It has been posited that a rapid and widely available diagnostic test for TB with sensitivity of 85% for smear-positive and smear-negative cases, and a specificity of 97% can save 400,000 lives annually [4]. For many years AFB microscopy was the mainstay of TB diagnosis in Nigeria until 2010, when due to several limitations (including low sensitivity and inability to diagnose Rifampicin resistant TB), the molecular GeneXpert MTB/Rif assay was recommended by World Health Organization (WHO) to be the initial diagnostic test. However, the challenges associated with infrastructural and environmental requirements for successful GeneXpert implementation especially in resource challenged settings like Nigeria have resulted in limitations in coverage and accessibility. Despite having 507 installed GeneXpert machines, the proportion of bacteriologically diagnosed TB patients notified by the country in 2021 who were tested with molecular WHO-recommended Diagnostic tests (mWRDs) was just 79% [1]. The limited access to mWRDs also reflected in the low DR-TB notification for the country, implying a pool of missing DR-TB patients yet to be diagnosed and placed on treatment.

In January 2020, WHO released a rapid communication on the use of molecular assays as initial tests for the diagnosis of tuberculosis, recommending Truenat as a replacement for smear microscopy in TB diagnosis & detection of rifampicin resistance [5]. Truenat Test is a rapid molecular test manufactured by Molbio, an Indian Company, for diagnosis of active TB. It is a portable, battery-operated, chip-based test which detects Mycobacterium tuberculosis (MTB) in approximately one hour and rifampicin (RIF) resistance in another 40–60 minutes. It can be used at ambient temperatures up to 40 degrees Celsius. Truenat presents as a cost-effective molecular test that can be used as a near point-of-care test in peripheral facilities and “low-infrastructure” settings to diagnose TB and potentially save thousands of lives [6].

Truenat assays have a high sensitivity (80–87%) and specificity (95–97%) when compared with a composite reference standard consisting of GeneXpert and culture results [6]. There is also a high correlation (92.7%) between Xpert MTB/RIF and Truenat in MTB detection.4 The chip-based test has been designed to simplify the process of real-time polymerase chain reaction (PCR) from ‘sample to result’ so that laboratories with minimal infrastructure can easily perform these tests routinely in their facilities and report PCR results in less than an hour [7].

Based on the recent WHO recommendation of Truenat, the Stop TB Partnership in 2021 procured and donated 38 Truenat Machines to Nigeria as part of the USAID-funded Introducing New Tools Project (iNTP). The iNTP project is the largest multi-country implementation of Truenat instruments. The project aimed to provide access to high quality, innovative diagnostic tools for TB among populations in hard-to-reach areas. This study sought to determine the perceived ease of use of Truenat as a diagnostic tool for TB among Truenat Laboratory staff in Nigeria.

Materials and methods

Study setting

Nigeria is the most populated country in Africa and occupies an area of land which is approximately 923,768 square kilometers. Administratively, the country is divided into 36 states and the Federal Capital Territory. The states serve as the second tier of government. The states are also grouped into six geo-political zones including northwest, northeast and north-central zones. Others include the southwest, southeast and south-south geo-political zones. There are 774 local government areas which form the third tier of government.

This study was conducted in 14 states in Nigeria which were selected for the implementation of Truenat intervention and supported by the USAID-funded TB LON projects. (See Fig 1). The States included Kano, Katsina, Kaduna, Bauchi, Nasarawa and Taraba in the Northern part of the country as well as Akwa-Ibom, Anambra, Cross River, Delta, Rivers, Lagos, Osun and Oyo States located in the southern part of the country. The USAID TB-LON 3 project implemented by the Institute of Human Virology of Nigeria (IHVN) is located in three states in the southwest geo-political zone of the country namely Lagos, Osun and Oyo states. The USAID TB-LON 1& 2 projects are located in the remaining 11 states implemented by KNCV Tuberculosis Foundation Nigeria.

10.1371/journal.pgph.0003652.g001 Fig 1 Map of Nigeria indicating states implementing Truenat under the iNTP.

Study design

A health facility based cross-sectional study design was used.

Study population

All trained Laboratory personnel operating the Truenat equipment in the 38 Truenat sites in the country who were willing to participate in the study were included.

Methods and data collection

Data was collected using a pre-tested, semi-structured questionnaire. The questionnaire which was self-administered was designed by the researchers. Pre-testing of the questionnaire was conducted among eight Laboratory personnel who had been trained and operated the Truenat machine in the past. However, at the time of the study, these personnel were no longer working at the various health facilities where the Truenat machines were located.

Study tools and variables

The questionnaire utilized both closed questions (including a five-point Likert scale numbered 1–5) and open-ended questions. The domains represented in the questionnaire included initiation of Truenat testing, sample preparation and testing, training, time required for Truenat testing, reporting, waste disposal, equipment breakdown and troubleshooting.

Data management

Data entry and analysis were done using IBM Statistical Product for Service Solutions (SPSS) statistical software, version 25. Categorical variables were presented using frequencies and proportions while continuous variables were summarized using mean and standard deviation. Chi square test was used in the analysis and the level of statistical significance was determined by a p value of <0.05.

The outcome measure of the study was Ease of use of Truenat, and this was assessed using twenty-three variables which elicited responses from all the respondents. The variables were measured using a five-point Likert scale where respondents provided ratings on a scale from 1–5. Specifically, 1 represented ‘strongly disagree’, 2 denoted ‘disagree’, 3 indicated ‘neutral’, 4 represented ‘agree’, while 5 represented ‘strongly agree’. Reverse scoring was used for questions that were negatively worded. Each of the 23 variables was analyzed quantitatively and qualitatively using mean and standard deviation and frequencies and proportions. The mean and standard deviation for each of the 23 variables was obtained. Also, the mean of each of the six domains in the questionnaire including initiation of Truenat testing, sample preparation and testing, training, reporting, waste disposal, equipment breakdown and troubleshooting were also obtained. Then the overall mean score for the entire 23 variables used to assess ease of use was obtained.

Furthermore, for the purpose of analysis the responses to each of the variables were categorized into positive and negative (not represented in the tables). For each response in the positive, a score of one was given to each respondent while a score of zero was assigned for a negative response. The cumulative score for the 23 variables for each respondent was then obtained. Respondents who scored ≥70% of the total score were designated as having reported ‘Good’ Ease of use of Truenat, while respondents who scored <70% were regarded as having reported ‘Poor’ Ease of use of Truenat. The socio-demographic and facility-related characteristics of the respondents were then cross-tabulated with the outcome variable to determine factors associated with ‘Good’ Ease of use of Truenat and the level of statistical significance was determined by a p value of <0.05.

Ethical approval

Ethical approval for the study was obtained from the National Health Ethics Research Committee (NHREC). (Approval number NHREC/01/01/2007-05/04/2023). Participants were recruited for the study from April 11th to April 28th 2023 after which the process of data collection commenced. Each respondent signed a written informed consent form before participating in the study. The respondents were informed that participation in the study was voluntary, and they were free to withdraw from the study even after giving consent. The respondents were assured of anonymity and confidentiality of data.

Results

Fifty Truenat Laboratory staff participated in the study representing a response rate of 100%. The mean age of the respondents was 36.5±7.9 years. A higher proportion, 58.0% were males. The majority of the respondents, 70.0%, were trained when the Truenat machines were installed. A higher proportion of the health facilities where the respondents worked, 86.0% were public facilities and also DOTS centers, 80.0% (Table 1).

10.1371/journal.pgph.0003652.t001 Table 1 Socio-demographic characteristics of the respondents and characteristics of facilities.

Variable	Frequency
(n = 50)	Percent (%)	
Age of respondents			
Mean±SD	36.5±7.9		
Age of respondents in groups			
<30 years	12	24.0	
30–34 years	9	18.0	
35–39 years	13	26.0	
≥40 years	16	32.0	
Gender			
Male	29	58.0	
Female	21	42.0	
No. of years of laboratory experience			
<10 years	27	54.0	
≥10 years	23	46.0	
No. of years in TB program			
<5 years	20	40.0	
≥5 years	30	46.0	
Respondent was part of initial set of Truenat users trained when machine was installed			
Yes	35	70.0	
No	15	30.0	
Respondent type of health facility			
Public	43	86.0	
Private	7	14.0	
Respondent facility is a DOTS center			
Yes	40	80.0	
No	10	20.0	
Respondent facility is a microscopy center			
Yes	30	60.0	
No	20	40.0	
Respondent facility is a center for TB LAMP			
Yes	3	6.0	
No	47	94.0	

Table 2 shows responses to variables for ease of initiation of testing and sample preparation. The mean score for being proficient with operating the Truenat machine was 4.5±0.5. The mean score for ease of initiation of Truenat testing was 4.6±0.4, while the mean score for ease of sample preparation for DNA extraction was 4.2±0.8. The mean score for ease of performing quality control procedures was 3.8±1.1. The mean score for the domain on sample preparation and testing was 3.8±0.5.

10.1371/journal.pgph.0003652.t002 Table 2 Initiation of testing and sample preparations for Truenat.

Variable	Mean
±SD	Strongly disagree
n (%)	Disagree
n (%)	Neutral
n (%)	Agree
n(%)	Strongly Agree
n(%)	
Initiation of Truenat testing in the center							
Truenat instrument system is easy to install and set up	4.4±0.8	1 (2.3)	0 (0.0)	1 (2.3)	20 (45.50	22 (50.0)	
Initiating startup sequence steps for daily operations and handling of machine is easy	4.6±0.5	0 (0.0)	0 (0.0)	0 (0.0)	22 (44.0)	28 (56.0)	
Machine screen-display user interface is easy to operate for entering data	4.6±0.5	0 (0.0)	0 (0.0)	0 (0.0)	19 (38.0)	31 (62.0)	
I consider myself proficient with operating the Truenat machine	4.5±0.5	0 (0.0)	0 (0.0)	1 (2.0)	24 (48.0)	25 (50.0)	
Initiation of Truenat testing (Average score)	4.6±0.4						
Sample preparation and testing							
Sample preparation for DNA extraction using Trueprep device is an easy operation	4.2±0.8	1 (2.0)	1 (2.0)	5 (10.0)	24 (48.0)	19 (38.0)	
Transfer of extracted DNA elute from elute collection tube to PCR reagents is an easy procedure	4.5±0.5	0 (0.0)	0 (0.0)	1 (2.0)	25 (50.0)	24 (48.0)	
Transfer of mixed DNA elute solution from microtube to MTBPlus chip reaction well is an easy procedure	4.3±0.6	0 (0.0)	0 (0.0)	3 (6.0)	29 (58.0)	18 (36.0)	
Further testing of MTB positive sample for RIF resistance is an easy procedure	4.2±0.9	1 (2.0)	3 (6.0)	0 (0.0)	27 (54.0)	19 (38.0)	
Quality control procedures are easy to follow and execute	3.8±1.1	1 (2.0)	7 (14.0)	6 (12.0)	21 (42.0)	15 (30.0)	
Non-availability of power for charging is a major structural challenge to the operation of Truenat	2.7±1.4	11 (22.0)	19 (38.0)	4 (8.0)	7 (14.0)	9 (18.0)	
Operating Truenat machine requires less laboratory consumables than AFB microscopy	2.5±1.3	14 (28.0)	16 (32.0)	6 (12.0)	10 (20.0)	4 (8.0)	
Operating Truenat machine requires less manual steps than AFB microscopy	3.1±1.6	14(28.0)	6 (12.0)	5 (10.0)	13 (26.0)	12 (24.0)	
I prefer using Truenat to AFB microscopy	4.7±0.7	0 (0.0)	1 (2.0)	2 (4.0)	10 (20.0)	37 (74.0)	
Sample preparation and testing (Average score)	3.9±0.5						

Table 3 shows the responses to variables for domains of training, breakdown and troubleshooting. The mean score for the training domain was 4.3±0.5. The mean score for the reporting domain was 4.0±0.8. The mean score for waste disposal was 3.1±1.2. The mean score for breakdown and trouble-shooting domain was 4.0±0.7. The mean score for the training, breakdown/troubleshooting domain was 4.0±0.4.

10.1371/journal.pgph.0003652.t003 Table 3 Training, breakdown and troubleshooting.

Variable	Mean±SD	*SD	Disagree	Neutral	Agree	*SA	
Training							
Training received for Truenat operation was adequate and sufficient	4.1±0.8	0 (0.0)	3 (6.0)	4 (8.0)	26 (52.0)	17 (34.0)	
Quality of post-training technical support received is adequate	4.2±0.9	1 (2.0)	3 (6.0)	2 (4.0)	25 (50.0)	19 (38.0)	
Easy to provide step down training to new lab staff on how to operate the machine	4.5±0.5	0 (0.0)	0 (0.0)	1 (2.0)	23 (46.0)	26 (52.0)	
Training (Average score)	4.3±0.5						
Reporting							
Result from Truenat test is easy to report	4.7±0.4	0 (0.0)	0 (0.0)	0 (0.0)	13 (26.0)	37 (74.0)	
Easy to sort the results and get summaries of the tests done from the machine	3.7±1.2	2 (4.0)	8 (16.0)	8 (16.0)	15 (30.0)	17 934.0)	
Summary results for all the tests done within a period can be exported	3.6±1.4	5 (10.0)	8 (16.0)	7 (14.0)	14 928.0)	16 (32.0)	
Reporting (Average score)	4.0±0.8						
Waste disposal							
Waste generated from Truenat testing requires its own special lab disposal methods that are available	3.1±1.2	5 (10.0)	13 (26.0)	8 (16.0)	21 (42.0)	3 (6.0)	
Breakdown and troubleshooting							
Conducting daily maintenance on Truenat machine is easy	4.2±0.7	0 (0.0)	2 (4.0)	2 (4.0)	31 (62.0)	15 (30.0)	
Flushing the system when there is blockage is an easy procedure	4.2±1.0	0 (0.0)	5 (10.0)	5 (10.0)	17 (34.0)	23 (46.0)	
Replacement of the slider glass on Truelab bays is easy	4.1±1.0	1 (2.0)	3 (6.0)	7 (14.0)	16 (32.0)	23 (46.0)	
Technical support by service engineers is easy to get during breakdown and for troubleshooting	3.5±1.3	6 (12.0)	6 (12.0)	6 (12.0)	23 (46.0)	9 (18.0)	
Breakdown and trouble-shooting (Average score)	4.0±0.7						
GRAND TOTAL SCORE (Average)	4.0±0.4						
* SD—Strongly disagree, SA—Strongly agree

Fig 2 shows responses for Truenat operations and proficiency. The median number of tests before the respondents got proficient with the Truenat machine was 9.0 tests. (IQR = 4.0–20.0). The median number of days needed by the respondents to become proficient with the Truenat machine was 4 days (IQR, 4-20days). The median number of tests the respondents are able to analyze in a normal eight working hours was 10 tests, (IQR = 8–15 days). The median time in minutes to conduct a Truelab MTBPlus test from start to finish was 60 minutes (IQR = 60–80 minutes). The median additional time in minutes to conduct the Truenat MTB-RIF test was 60 minutes (IQR = 60–80 minutes).

10.1371/journal.pgph.0003652.g002 Fig 2 Truenat operations and proficiency.

Key B11Tests; Estimated no of days before staff gets proficient with Truenat machine. B12aTimi: Estimated time in minutes to conduct a Truelab MTBPlus test from start to finish. B12baddi: Additional time in minutes to conduct Truenat MTB-RIF Dx test. B5Notest: No. of tests/samples that can be analyzed in an eight -hour shift. B6DaysOP: No. of days needed to become proficient with Truenat machine.

Table 4 shows the power source to charge the Truenat machine. The major sources of power supply for charging the Truenat machine included public power supply, 65.8% and generators, 65.8%. For respondents who reported insufficient training, areas highlighted for additional training included DNA extraction, 28.6% and full scale training, 28.6%.

10.1371/journal.pgph.0003652.t004 Table 4 Truenat power source and additional training requirements.

Variable	Frequency
(n = 38)**	Percent (%)	
Power source to charge Truenat machine*			
Public power supply	25	65.8	
Generator	25	65.8	
Solar	6	15.8	
Inverter	6	15.8	
None	1	2.6	
Where further training is required	(n = 7)		
DNA extraction	2	28.6	
Will require full training (received step down training)	2	28.6	
Trueprep/Truelab	1	14.3	
Maintenance	1	14.3	
Superuser	1	14.3	
*multiple responses

** Number of Truenat sites

Table 5 shows operational challenges of the Truenat machine. Commonest operational challenges that needed service support included Trueprep errors/blockage, 47.4% and connectivity/network issues, 13.2%. In 71.1% of cases, Trueprep has been repaired /replaced while for Truelab, it is 23.7%.

10.1371/journal.pgph.0003652.t005 Table 5 Operational challenges of Truenat machine.

Variable	Frequency
(n = 38)*	Percent (%)	
Commonest operational challenge that needed Molbio service support			
Trueprep errors/blockage	18	47.4	
Connection/network issues	5	13.2	
Invalid result/error from Truelab	4	10.5	
No challenge	11	28.9	
Sample rejected because of inability to test			
Yes	30	78.9	
No	8	21.1	
Reason for rejection*	(n = 30)		
Machine faulty	19	63.3	
Sample insufficient/bloody	7	23.3	
Reagent stock-out/expired	3	10.0	
Power challenges	1	3.3	
Truelab replaced/repaired at any time	(n = 38)		
Yes	9	23.7	
No	29	76.3	
If yes, how many times	(n = 9)		
Once	4	44.4	
Twice	5	55.6	
Trueprep replaced/repaired at any time	(n = 38)		
Yes	27	71.1	
No	11	28.9	
If yes, the number of times	(n = 27)		
Once	10	37.0	
Twice	7	26.0	
Three times and above	10	37.0	
Micro-printer replaced/repaired at any time	(n = 38)		
Yes	4	10.5	
No	34	89.5	
If yes, the number of times	(n = 4)		
Once	2	50.0	
Twice	2	50.0	
** Number of Truenat sites

Fig 3 shows the perceived ease of use of Truenat among the respondents. A higher proportion of the respondents, 76.0% had Good Ease of use of Truenat.

10.1371/journal.pgph.0003652.g003 Fig 3 Perceived ease of use of Truenat.

Table 6 shows the factors associated with Good ease of use of Truenat among the respondents. A higher proportion of respondents who were 38 years and above(76.2%), had good ease of use of Truenat when compared with those who were less than 38 years old, 74.2% but the difference in proportions was not found to be statistically significant, (χ2 = 0.146,p = 0.702). Comparable proportions of male, 75.9% and female respondents, 85.7% had good ease of use of Truenat, (χ2 = 0.001,p = 0.979).

10.1371/journal.pgph.0003652.t006 Table 6 Factors associated with good ease of use of Truenat among the respondents.

Variable	Ease of use of TRUENAT (n = 50)	χ2 p value	
Good N (%)	Poor N (%)	
Age of respondents				
<38 years	23(74.2)	8 (25.8)	0.146 0.702	
≥38 years	15 (78.9)	4 (21.1)		
Gender				
Male	22 (75.9)	7 (24.1)	0.001 0.979	
Female	16 (76.2)	5 (23.8)		
Type of health facility				
Public health facility	31 (72.1)	12 (27.9)	FT 0.174	
Private health facility	7 (100.0)	0 (0.0)		
No of years of lab experience				
<10 years	20 (74.1)	7 (25.9)	0.119 0.730	
≥10 years	18 (78.3)	5 (21.7)		
No of years in National TB program				
<5 years	16 (80.0)	4 (20.0)	0.292 0.589	
≥5 years	22 (73.3)	8 (26.7)		
Facility is a DOTS center				
Yes	32 (80.0)	8 (20.0)	1.754 0.185	
No	6 (60.0)	4 (40.0)		
Facility is a microscopy center				
Yes	23 (76.7)	7 (23.3)	0.018 0.892	
No	15 (75.0)	5 (25.0)		
Facility is a TB LAMP center				
Yes	3 (100.0)	0 (0.0)	1.008 0.315	
No	35(74.5)	12 (25.5)		
Received training when machine was installed				
Yes	27 (77.1)	8 (22.9)	0.084 0.773	
No	11 (73.3)	4 (26.7)		
FT Fishers exact test

Discussion

Findings from this study indicate that there is a high level of acceptability of Truenat by the end-users. In addition, there is a strong preference for using Truenat over microscopy among the Laboratory staff. From the results of our study, 70% of the respondents were part of those trained when the Truenat machines were installed. In a study in India, 80% of the respondents had participated in a training on Truenat testing [4]. This could be an indication that training of healthcare workers, especially Laboratory staff on use of Truenat is a pre-requisite before or during the implementation period. There could have been staff attrition on the part of the Laboratory staff of those initially trained, hence those not trained at installation received on-the-job step-down training. The study results also showed that >90% of the respondents (including those who were not trained at installation) indicated that the training received was adequate, implying that they perceived the step-down training received to be adequate.

The median number of tests before the Laboratory staff gets proficient with the Truenat machine was 9 tests. This is similar to findings from a study in India where the median number of tests before the respondents became comfortable in performing Truenat tests was found to be 10 [4]. Also, the median number of days to attain proficiency with the Truenat machine was four days. This short period of time to attain proficiency in use of Truenat which was achieved post-training is an indication that the Truenat machine is easy to use by a trained Laboratory staff with minimal technical support and hence can be rolled-out easily. A study in India had described the Truenat TB test as a simple method and implied that laboratory technicians with minimal training can perform the test using the machine [8]. This also conforms to the result of this study in which the majority of respondents, 76% agreed or strongly agreed on the adequacy of the quality of training on use of Truenat received.

The median time in minutes to conduct a Truelab MTBPlus test from start to finish in this study was 60 minutes. A previous study also found that it took the Truenat MTB test about 60 minutes for the detection of TB [9]. Another study in India also concluded that the turn-around time for Truenat is approximately one hour [8]. The final report on operational feasibility and performance of Truenat MTB RIF assays in field settings in India concluded that the Truenat assay is designed to complete the detection of mycobacterium TB in 35 minutes [10]. From the results of this study, the median time to complete both MTB detection and RIF resistance was 120 minutes. An early study from India reported Truenat simultaneously detected RIF resistance and mycobacterium tuberculosis in less than 3 hours [11].

The commonest operational challenge that needed Molbio service support was Trueprep related problems. The study respondents reported three times more Trueprep challenges than they did for Truelab challenges with the Trueprep replaced at least once in 27 facilities compared to 9 facilities for the Truelab. The proportions in our study are higher than reported in a study in India involving 243 Truenat sites where seven sites had their Trueprep replaced at least once, while six sites had their Truelab device replaced at least once since installation [7]. With the increased use and scale up of Truenat to other tropical environments outside India it is expected that more information on operational performance, durability and challenges will become available.

Under sample testing almost all respondents agreed or strongly agreed that transfer of extracted DNA elute from elute collection tube to PCR reagents was an easy procedure. Same was the case for transfer of mixed DNA elute solution from micro-tube to MTBPlus chip reaction well. This is another confirmation that performing the Truenat test is easy for Laboratory staff who have received training on the use of Truenat. Also, 98% of the respondents agreed or strongly agreed that they consider themselves proficient in performing the Truenat test. Furthermore, 98% of the respondents agreed or strongly agreed that it is easy to provide step down training to new Laboratory staff on how to operate the Truenat machine. Expectedly, the mean domain score for training was second only to initiation of Truenat testing in the facility. The average total score for all the variables was 4.0±0.4 which reveals a good ease of use of the Truenat machine by the respondents. A higher proportion of the respondents, 76.0% had good ease of use of Truenat. From the results of this study, no factor significantly influenced the good ease of use of the Truenat machine among the respondents.

Conclusions

Truenat machine is easy to use for a trained laboratory staff with minimal technical support and hence could be rolled out easily and successfully by various National TB Programs. Considering the very high Trueprep challenges reported, there is need for further studies into the common errors/challenges, the contexts surrounding them and the programmatic intervention to address the high rate of Trueprep equipment faults.

Supporting information

S1 Data (XLSX)

The authors acknowledge the support by the National Tuberculosis and Leprosy Control Program, State TB Program Managers across the 18 USAID TB-LON supported states in Nigeria, Tuberculosis Local Government Supervisors, Health care workers in the selected sites, and study participants for their contribution to the success of this study. We also appreciate the technical support and input from the Stop TB partnership introducing new tools project (iNTP) team and USAID Washington TB Division.

10.1371/journal.pgph.0003652.r001
Decision Letter 0
Rajendran Priya Academic Editor
© 2024 Priya Rajendran
2024
Priya Rajendran
https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Submission Version0
17 Jul 2024

PGPH-D-24-01529

Perceived ease of use of Truenat among laboratory staff as a new diagnostic tool for TB in Nigeria: result of a pilot roll-out

PLOS Global Public Health

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Reviewer #1: Line no. 226-228: Table 4 shows the power source to charge the Truenat machine. The major sources of power supply for charging the Truenat machine included public power supply, 65.8% and generators, 65.8%” Does this mean all the public power sources were using generators?

The two categories represented in Figure 3 are confusing. It would be better if the two responses were mentioned as “Good” and “Poor”

The study didn’t evaluate the performance and ease of use of Truenat in high burden settings. The average number of Truenat tests performed in the study centres was just 10, while most high-burden centres may receive 30 to 50 samples for TB diagnosis in a day. This aspect was not studied or included in the discussion.

The ease of use of Truenat has been compared only with microscopy. What was the opinion of the respondents in comparison to Genexpert?

Reviewer #2: The manuscript is well written and addresses one or the major challenges of performance of Truenat in programatic setting.

1. Truenat Rif testing has more indeterminate, has the authors try to capture as part of the performance.

2. Performance of Truenat compared to smear may be less labour intensive but compare to GeneXpert its more labour intensive and the chances of cross contamination during the testing may be high with out training. This has not been discussed.

3. The more common true prep issue of blockage is due to improper mucolysis or the machine problem has not been clearly marked in the manuscript.

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Reviewer #1: Yes: Noyal Mariya Joseph

Reviewer #2: Yes: S Siva Kumar

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10.1371/journal.pgph.0003652.r002
Author response to Decision Letter 0
Submission Version1
5 Aug 2024

Attachment Submitted filename: Reviewer comments and response from Authors.docx

10.1371/journal.pgph.0003652.r003
Decision Letter 1
Rajendran Priya Academic Editor
© 2024 Priya Rajendran
2024
Priya Rajendran
https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Submission Version1
8 Aug 2024

Perceived ease of use of Truenat among laboratory staff as a new diagnostic tool for TB in Nigeria: result of a pilot roll-out

PGPH-D-24-01529R1

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Reviewer Comments (if any, and for reference):
==== Refs
References

1 World Health Organization. Global tuberculosis report 2022. Geneva. WHO 2022,
2 World Health Organization. Global tuberculosis report 2021. Geneva. WHO 2021,
3 KNCV Tuberculosis Foundation, Nigeria. Nigeria is among the 14 high burden countries for TB. Available at https://kncvnigeria.org. Accessed 12th April, 2024.
4 Jeyashree K. , Shanmugasundaram D. , Rade K , Gangakhedkar R , Murhekar M . Impact and operational feasibility of TrueNat™ MTB/Rif under India’s RNTCP. Public health action. 2020;10 (3 ): 87–91. doi: 10.5588/pha.20.0004 33134121
5 World Health Organization. Consolidated guidelines on tuberculosis. Module 3: diagnosis–rapid diagnostics for tuberculosis detection. Geneva, Switzerland: World Health Organization; 2020
6 STOP TB Partnership. Practical Guide to Implementation of Truenat™ Tests for the Detection of TB and Rifampicin Resistance. Geneva, Switzerland: STOPTB Partnership; 2020.
7 Meaza A , Tesfaye E , Mohamed Z , Zerihum B , Seid G , Eshetu K , et al . Diagnostic accuracy of Truenat Tuberculosis and Rifampicin-Resistance assays in Addis Ababa, Ethiopia. PLoS One.2021;16 (12 ):e0261084. doi: 10.1371/journal.pone.0261084 34962949
8 Vijayalakshmi J , Surekha A , Renuka Devi A , Uma Devi S . Truenat- A novel diagnostic tool for rapid detection of mycobacterium tuberculosis and Rifampicin resistance in pulmonary samples. Int J Curr Microbiol App Sci. 2019;8 (10 ):1260–1267.
9 Nikam C , Jagannath M , Narayanan M , Ramanabhiraman V , Kazi M , Shetty A , et al . Rapid diagnosis of mycobacterium tuberculosis with Truenat MTB: a near-care approach. PLoS ONE. 2013;8 (1 ):e51121. doi: 10.1371/journal.pone.0051121 23349670
10 Tripathy S , Khaparde S , Rao R , Kumar N , Singh M , Ramachandran R , et al . Final report on operational feasibility and performance of Truenat MTB RIF assays in field settings under the Revised National Tuberculosis Control Program. Available at https://www.molbiodiagnostics.com/uploads/product_evaluation/2_productevaluation_220190405.134141.pdf. Accessed 21st April, 2024.
11 Nikam C , Kazi M , Nair C , Jaggannath M , Manoj M , Vinaya R , et al . Evaluation of the Indian Truenat micro RT-PCR device with GeneXpert for case detection of pulmonary tuberculosis. International Journal of Mycobacteriology. 2014;3 (3 ):205–210. doi: 10.1016/j.ijmyco.2014.04.003 26786489
