Diagnostic performance and costs of Capilia TB for <i>Mycobacterium tuberculosis</i> complex identification from broth‐based culture in Bangkok, Thailand

Ngamlert, Keerataya; Sinthuwattanawibool, Chalinthorn; McCarthy, Kimberly D.; Sohn, Hojoon; Starks, Angela M.; Kanjanamongkolsiri, Photjanart; Anekvorapong, Rapeepan; Tasaneeyapan, Theerawit; Monkongdee, Patama; Diem, Lois; Varma, Jay K.

doi:10.1111/j.1365-3156.2009.02284.x

Cited by 44 publications

(40 citation statements)

References 12 publications

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“…One previous study using TB ICT kit detected false negativity in 6 M. tuberculosis isolates and genomic RD1-RD3 analysis showed mutation in all 6 strains. 15 The limitations of this study was no genetically confirmed M. tuberculosis strains to attribute to mutation occurring in the specific gene of M. tuberculosis isolates. Tuberculosis antigen cocktail rapid ICT :60-5 TB antigen cocktail rapid ICT from CSF specimens had a sensitivity of 83.3% and specificity of 68.5%.…”

Section: Discussionmentioning

confidence: 99%

The Validity of Mycobacterium Tuberculosis Antigens Cocktail: Esat-6, CFP-10 and Mpt64 in Sputum and Cerebrospinal Fluid for Pulmonary Tuberculosis and Tuberculous Meningitis Diagnosis

Turbawat¹,

Gustiani²,

Noviani³

et al. 2015

IJIHS

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Objective: To determine the validity of tuberculosis (TB) antigen cocktail (ESAT-6, CFP-10 and MPT64) for pulmonary tuberculosis and TB meningitis diagnosis.Methods: This is a descriptive observational study design. The study was conducted at the Clinical Pathology Laboratory of Dr. Hasan Sadikin General Hospital during September 2012 until March 2013 for the pulmonary tuberculosis study and from January 2014 to May 2014 for the TB meningitis study. The TB antigen cocktail rapid immunochromatography (ICT) test was conduncted on all samples. The sputum and cerebrospinal fluid (CSF) were cultured as gold standards.Results: There were 149 pulmonary and 41 TB meningitis subjects. The sensitivity of rapid ICT TB antigen cocktail for diagnosing pulmonary tuberculosis was 95.7% with a specificity of 87.2%. Of 41 TB meningitis subjects, based on Marais criteria, there were 6 (16%) subjects with a definite TB meningitis, 26 (63%) subjects with probable TB meningitis, and 9 (21%) subjects with possible TB meningitis. The sensitivity and specificity of TB antigen cocktail rapid ICT for TB meningitis diagnosis were 83.3% and 68.5%, respectively. Conclusions:In this study, rapid ICT TB antigen cocktail (ESAT-6, CFP-10 and MPT64) from sputum sample has good validity for diagnosing a pulmonary tuberculosis. Cerebrospinal fluid sample has moderate validity to diagnose TB meningitis.

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Section: Discussionmentioning

confidence: 99%

The Validity of Mycobacterium Tuberculosis Antigens Cocktail: Esat-6, CFP-10 and Mpt64 in Sputum and Cerebrospinal Fluid for Pulmonary Tuberculosis and Tuberculous Meningitis Diagnosis

Turbawat¹,

Gustiani²,

Noviani³

et al. 2015

IJIHS

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“…Thus, several such tests are commercially available, including the Capilia TB assay (Tauns Laboratories, Inc., Numazu, Japan), the Tibilia rapid test (Hangzhou, China), the SD Bioline TB Ag MPT64 rapid test (Standard Diagnostics, South Korea), and the MGIT TBc ID test. Previous studies have demonstrated that these assays all had outstanding performance, exhibiting 92.4 to 100% sensitivity and 94 to 100% specificity in identifying the M. tuberculosis complex (Table 4) (13,14,21,23,24,27, and M. Warns et al, presented at the 30th Annual Congress of the European Society of Mycobacteriology, Porto, Portugal, July 2009). In this study, we found that the TBc ID test exhibited 98.8% sensitivity and 100% specificity compared to biochemical tests.…”

Section: Discussionmentioning

confidence: 99%

“…When discrepant results between the NAA, TBc ID assays, and conventional biochemical confirmation tests were observed, the results from mpb64 gene sequencing were used to resolve the discrepancies. Mutations in the mpb64 gene were analyzed using PCR amplification, and the resulting product was sequenced using the following oligonucleotide primers: AMS-50-F (5Ј-TCGATCTGCTAGCTTGAGTCTGGT-3Ј) and AMS-51-R (5Ј-ACCACCGCACCAAGGCTGCTGTCTA-3Ј) (23). The PCR products were sequenced using an ABI 3730 automated sequencer (Applied Biosystems, Life Technologies Corporation, CA) under standardized conditions.…”

Section: (Iv) Pcr-rflpmentioning

confidence: 99%

Evaluation of the Rapid MGIT TBc Identification Test for Culture Confirmation of Mycobacterium tuberculosis Complex Strain Detection

Chen

Wu³

et al. 2011

J Clin Microbiol

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A culture confirmation test for the detection of Mycobacterium tuberculosis complex strains that uses a lateral-flow immunochromatographic assay to detect the MPB64 antigen, the MGIT TBc identification (TBc ID) test, has been developed. We evaluated the performance of the TBc ID test in the detection of the M. tuberculosis complex in 222 primary-positive liquid cultures. We compared these results to those of nucleic acid-based identification and conventional biochemical tests. The validity of the TBc ID test was determined, and all of the nontuberculous mycobacteria (NTM) and Nocardia species tested were found to be negative. The detection limit of the TBc ID test was 5 ؋ 10 5 CFU/ml, and for IS6110 real-time PCR it was 5 CFU/ml. All of the M. tuberculosis and M. africanum cultures were found to be positive, while M. bovis and M. bovis BCG cultures were negative. With the exception of 1 contaminated culture, the 221 culture-positive isolates contained 171 (77.5%) M. tuberculosis isolates, 39 (17.6%) NTM species, and 11 (5.0%) unidentified species. Two culture-positive isolates harbored a 63-bp deletion at position 196 of the mpb64 gene. The sensitivity, specificity, positive predictive values, and negative predictive values of the TBc ID test were 98.8, 100, 100, and 95.1%, respectively. Furthermore, the approximate turnaround time for real-time PCR was 4 h (including buffer and sample preparation), while for the TBc ID test it was less than 1 h. We suggest an algorithm for the primary identification of M. tuberculosis in liquid culture using the TBc ID test as an alternative to conventional subculture followed by identification using biochemical methods.In 2007, the World Health Organization (WHO) adopted a policy that recommended the use of liquid culture methods for culture and drug susceptibility tests as a standard for tuberculosis (TB) diagnosis and case management (28). The Taiwan Centers for Disease Control (CDC) recommended that liquid and solid media be used simultaneously for mycobacterial culture (7), and approximately 90% of clinical mycobacteriology laboratories in Taiwan use a liquid culture system for the isolation of the Mycobacterium tuberculosis complex from clinical specimens. Acid-fast bacillin (AFB) smear tests then are performed on positive cultures to dismiss contamination (4, 20). The turnaround time (TAT) for the recovery of the M. tuberculosis complex thus is reduced to 10 to 14 days (8, 18). Although the recovery of mycobacteria can be accelerated by using liquid culture systems, this practice provides only partial benefits if it is not accompanied by a rapid species identification test (16). Differentiating M. tuberculosis from nontuberculous mycobacteria (NTM) as soon as possible is important, particularly in situations in which NTM strains represent a considerable share of the clinical isolates.The identification of M. tuberculosis is time-consuming using conventional biochemical methods. The subculturing of isolated mycobacteria from liquid cultures onto solid media and their subs...

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“…Using simple and inexpensive monoclonal assays, such as the Capilia TB assay (a rapid and low-technology method), which uses monoclonal antibodies to detect a secreted mycobacterial protein (MPB64) during culturing (solid or liquid culture) allows it to differentiate Mtb from non-TB mycobacteria (Muyoyeta et al, 2010;Ngamlert et al, 2009). To shorten the time required for bacterial growth detection, Mtb can be isolated in both liquid-and solid-media cultures (Lu et al, 2002).…”

Section: New Approaches To Culturesmentioning

confidence: 99%

Diagnosis of Mycobacterium tuberculosis

Al-Zamel¹

2012

Understanding Tuberculosis - Global Experiences and Innovative Approaches to the Diagnosis

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Diagnostic performance and costs of Capilia TB for Mycobacterium tuberculosis complex identification from broth‐based culture in Bangkok, Thailand

Abstract: In Thailand, Capilia TB had acceptable sensitivity and specificity, was lower in cost and had shorter turn-around times. Laboratories investing in BBC should consider Capilia TB for identification of MTBC, after validation of performance in their setting.

Cited by 44 publications

References 12 publications

The Validity of Mycobacterium Tuberculosis Antigens Cocktail: Esat-6, CFP-10 and Mpt64 in Sputum and Cerebrospinal Fluid for Pulmonary Tuberculosis and Tuberculous Meningitis Diagnosis

The Validity of Mycobacterium Tuberculosis Antigens Cocktail: Esat-6, CFP-10 and Mpt64 in Sputum and Cerebrospinal Fluid for Pulmonary Tuberculosis and Tuberculous Meningitis Diagnosis

Evaluation of the Rapid MGIT TBc Identification Test for Culture Confirmation of Mycobacterium tuberculosis Complex Strain Detection

Diagnosis of Mycobacterium tuberculosis

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