Diagnostic Molecular Microbiology

Abstract

Molecular biological techniques have evolved expeditiously and in turn have been applied to the detection of infectious disease. Maturation of these technologies and their coupling with related technological advancement in fluorescence, electronics, digitization, nanodynamics, and sensors among others have afforded clinical medicine additional tools toward expedient identification of infectious organisms at concentrations and sensitivities previously unattainable. These advancements have been adapted in select settings toward addressing clinical demands for more timely and effective patient management.

Improved molecular laboratory productivity by consolidation of testing on the new random-access analyzer Alinity m

“…Although this technological revolution in molecular diagnostics was initially restricted to virology, such as for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV), or high-risk human papillomavirus (HR HPV), NAATs have since been applied to bacteriology, for the diagnosis of sexually transmitted infections (STIs), including Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). These examples represent infections with high disease burden requiring the implementation of automated platforms [1,2]. Consequently, clinical laboratories have seen consolidation of various testing departments into the molecular diagnostic space in a continuous process of technological evolution [3].…”

Automation and Molecular Diagnostics: A New Era in Clinical Microbiology

“…The principles behind this technique have allowed science to decipher the genomes of many species and serves as the basis for the field of molecular diagnostics. 2 Some of the first molecular tests to become FDA-approved and introduced into the clinical microbiology laboratory were single-target tests that utilize PCRbased amplification techniques. These assays were followed by technique modifications such as transcription-mediated amplification (TMA), loop-mediated isothermal amplification (LAMP), and helicase-dependent amplification (HDA), to name a few.…”

“…As can be seen on the FDA website 8 , there are multiple testing platforms and kits that allow for the direct detection of viral presence. Of the PCR-based technologies listed, all have their specific pros and cons mainly surrounding variability in sensitivity and specificity 2 , but collectively all greatly improve upon patient care. Selection of the ideal platform is a lab-specific determination that must be based upon technical expertise as well as space and budget constraints.…”

“…Another area of microbiology testing that has benefitted from molecular advancements is the identification of sexually transmitted infections (STIs). 2 STIs are noted public health issues 9 and some of the causative organisms are notoriously difficult or impossible to culture in standard laboratory settings (i.e. Chlamydia trachomatis and Trichomonas vaginalis).…”

“…Using molecular-based testing for suspected STIs or STI screening, especially for individuals at higher risk or who engage in high risk behaviors, greatly benefits public health due to more rapid testing and result reporting. 2,10 These single-target assays have also been of great use to patient/hospital management in terms of identification of drug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), etc.) and causes of nosocomial infections, such as Clostridioides difficile, which typically leads to patients being placed in isolation.…”