A Rapid and Sensitive Diagnostic Screening Assay for Detection of Mycobacteria Including <i>Mycobacterium tuberculosis</i> Directly from Sputum without Extraction

Cross, Lisa Jane; Anscombe, Catherine; McHugh, Timothy D.; Abubakar, Ibrahim; Shorten, Robert J.; Thorne, Nicola; Arnold, Cath

doi:10.1155/2015/593745

Cited by 4 publications

(2 citation statements)

References 17 publications

(16 reference statements)

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“…Other advantages include an increased sensitivity and specificity for the target DNA. However, the detection of amplified products using DNA intercalator dye such as SYBR ® Green is not specific [54]. The detection of mycobacteria can be achieved by the use specific probes.…”

Section: Real-time Pcrmentioning

confidence: 99%

Testing of Biological Products: A Review of Alternative Non-microbiological Techniques for Mycobacterial Testing

Marius,

Fernandez

2024

Preprint

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Mycobacteria can be one of the main contaminants of biological products, and their presence can have serious consequences on patients’ health. Thus, specific testing is necessitated by regulations such as the European Pharmacopoeia. The current pharmacopeial reference i.e., microbial culture method cannot ensure an exhaustive detection of mycobacteria due to their growth characteristics. Additionally, the method is time-consuming and requires a continuous supply of culture media, which could be further challenging. Thus, to overcome these challenges, pharmaceutical industries need to consider alternative non-microbiological techniques to detect these fastidious, slow-growing contaminating agents. This review provides an overview of alternative methods, which could be applied within a quality control environment of biological products, and underlines advantages and limitations of these methods. Nucleic acid amplification techniques or direct measurement of mycobacteria stands out as the most suitable alternatives for mycobacterial testing in biological products.

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Section: Real-time Pcrmentioning

confidence: 99%

Testing of Biological Products: A Review of Alternative Non-microbiological Techniques for Mycobacterial Testing

Marius,

Fernandez

2024

Preprint

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“…Other advantages include an increased sensitivity and specificity for the target DNA (Table 2). However, the detection of amplified products using DNA intercalator dye such as SYBR ® Green is not specific [56]. The detection of mycobacteria can be achieved with the use of specific probes [18].…”

Section: Real-time Pcrmentioning

confidence: 99%

Non-Microbiological Mycobacterial Detection Techniques for Quality Control of Biological Products: A Comprehensive Review

Marius,

Fernandez

2024

Microorganisms

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Mycobacteria can be one of the main contaminants of biological products, and their presence can have serious consequences on patients’ health. For this reason, the European Pharmacopoeia mandates the specific testing of biological products for mycobacteria, a critical regulatory requirement aimed at ensuring the safety of these products before they are released to the market. The current pharmacopeial reference, i.e., microbial culture method, cannot ensure an exhaustive detection of mycobacteria due to their growth characteristics. Additionally, the method is time consuming and requires a continuous supply of culture media, posing logistical challenges. Thus, to overcome these issues, pharmaceutical industries need to consider alternative non-microbiological techniques to detect these fastidious, slow-growing contaminating agents. This review provides an overview of alternative methods, which could be applied within a quality control environment for biological products and underlines their advantages and limitations. Nucleic acid amplification techniques or direct measurement of mycobacteria stand out as the most suitable alternatives for mycobacterial testing in biological products.

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Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Horne

Kohli

Zifodya

et al. 2019

Cochrane Database of Systematic Reviews

184

157

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Background Xpert MTB/RIF (Xpert MTB/RIF) and Xpert MTB/RIF Ultra (Xpert Ultra), the newest version, are the only World Health Organization (WHO)‐recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in persons with signs and symptoms of tuberculosis, at lower health system levels. A previous Cochrane Review found Xpert MTB/RIF sensitive and specific for tuberculosis ( ). Since the previous review, new studies have been published. We performed a review update for an upcoming WHO policy review. Objectives To determine diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for tuberculosis in adults with presumptive pulmonary tuberculosis (PTB) and for rifampicin resistance in adults with presumptive rifampicin‐resistant tuberculosis. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, to 11 October 2018, without language restriction. Selection criteria Randomized trials, cross‐sectional, and cohort studies using respiratory specimens that evaluated Xpert MTB/RIF, Xpert Ultra, or both against the reference standard, culture for tuberculosis and culture‐based drug susceptibility testing or MTBDR plus for rifampicin resistance. Data collection and analysis Four review authors independently extracted data using a standardized form. When possible, we also extracted data by smear and HIV status. We assessed study quality using QUADAS‐2 and performed meta‐analyses to estimate pooled sensitivity and specificity separately for tuberculosis and rifampicin resistance. We investigated potential sources of heterogeneity. Most analyses used a bivariate random‐effects model. For tuberculosis detection, we first estimated accuracy using all included studies and then only the subset of studies where participants were unselected, i.e. not selected based on prior microscopy testing. Main results We identified in total 95 studies (77 new studies since the previous review): 86 studies (42,091 participants) evaluated Xpert MTB/RIF for tuberculosis and 57 studies (8287 participants) for rifampicin resistance. One study compared Xpert MTB/RIF and Xpert Ultra on the same participant specimen. Tuberculosis detection Of the total 86 studies, 45 took place in high tuberculosis burden and 50 in high TB/HIV burden countries. Most studies had low risk of bias. Xpert MTB/RIF pooled sensitivity and specificity (95% credible Interval (CrI)) were 85% (82% to 88%) and 98% (97% to 98%), (70 studies, 37,237 unselected participants; high‐certainty evidence). We found similar accuracy when ...

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A Rapid and Sensitive Diagnostic Screening Assay for Detection of Mycobacteria Including Mycobacterium tuberculosis Directly from Sputum without Extraction

Cited by 4 publications

References 17 publications

Testing of Biological Products: A Review of Alternative Non-microbiological Techniques for Mycobacterial Testing

Testing of Biological Products: A Review of Alternative Non-microbiological Techniques for Mycobacterial Testing

Non-Microbiological Mycobacterial Detection Techniques for Quality Control of Biological Products: A Comprehensive Review

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

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