| dc.description.abstract | Mycobacterium tuberculosis (TB) is a major global health concern and ranks as one of the
leading causes of death worldwide. Before the COVID-19 pandemic, TB was the foremost cause
of mortality from a single infectious pathogen, surpassing HIV/AIDS. Currently, polymerase chain
reaction (PCR) is a key method used for detecting and diagnosing tuberculosis in laboratories and
clinics. Although PCR is known for its specificity and sensitivity, its accuracy can be influenced
by various factors, leading to unreliable results in some cases. To enhance the accuracy of TB
diagnostic tests, it is crucial to not only keep medical staff updated with the latest knowledge but
also to implement quality control systems in TB laboratories. Quality assurance of test results can
be significantly improved through Internal Quality Assurance (IQA) procedures and participation
in External Quality Assessment (EQA) programs. Positive controls are vital for proficiency testing,
training, and regulatory compliance within EQA programs. However, their availability is limited
due to the infectious nature and high biohazard risk associated with Mycobacterium tuberculosis,
necessitating stringent biosafety measures during handling and processing. As an alternative, mock
sputum samples containing Mycobacterium tuberculosis can help mitigate these challenges. This
study aimed to validate the homogeneity and stability of lyophilized sputum mock samples
containing Mycobacterium tuberculosis using qPCR. The results demonstrated that the samples
were fairly uniform, with each sample in the batch showing consistent characteristics. However,
stability tests require further data analysis with larger sample sizes. By evaluating the homogeneity
and stability of the sputum mock samples, this research contributes to the development of
standardized sample production for EQA programs. | en_US |
