Abstract
Management of curable sexually-transmitted infections (STI) such as Chlamydia can be revolutionized by highly sensitive nucleic acid testing that is deployable at the point-of-care (POC). Here we report the development of a mobile nucleic acid amplification testing (mobiNAAT) platform utilizing a mobile phone and droplet magnetofluidics to deliver NAAT in a portable and accessible format. By using magnetic particles as a mobile substrate for nucleic acid capture and transport, fluid handling is reduced to particle translocation on a simple magnetofluidic cartridge assembled with reagents for nucleic acid purification and amplification. A mobile phone user interface operating in tandem with a portable Bluetooth-enabled cartridge-processing unit facilitates process integration. We tested 30 potentially Chlamydia trachomatis (CT)-infected patients in a hospital emergency department and confirmed that mobiNAAT showed 100% concordance with laboratory-based NAAT. Concurrent evaluation by a nontechnical study coordinator who received brief training via an embedded mobile app module demonstrated ease of use and reproducibility of the platform. This work demonstrates the potential of mobile nucleic acid testing in bridging the diagnostic gap between centralized laboratories and hospital emergency departments.
Highlights
Curable sexually transmitted infections still present a major concern for public health
The conventional nucleic acid testing workflow involves an iterative process of addition and removal of aqueous reagents for the capture and purification of nucleic acids on a solid substrate, followed by the elution of purified sample for analysis using an enzymatic amplification reaction such as polymerase chain reaction (PCR)
Analyte capture and transport are facilitated by surface-modified magnetic particles, which can traverse between each reservoir when acted upon by an external magnetic field (Fig. 1b)
Summary
Curable sexually transmitted infections still present a major concern for public health. Nucleic acid amplification tests (NAATs) are the de facto gold standard assays recommended by the Centers for Disease Control and Prevention (CDC) with >90% clinical sensitivity and 99% specificity[9, 10]. Comparative studies suggest that point-of-care (POC) tests that are both sensitive and affordable may substantially change the discourse of chlamydia surveillance[10, 11], highlighting a major unmet need for a platform technology capable of delivering laboratory-based assays in a POC setting. We present a standalone, sample-to-answer mobile NAAT system for chlamydia surveillance, incorporating a droplet magnetofluidic cartridge processed in tandem with a portable electromechanical unit operated by a mobile phone interface. Central to the platform design is the mobile phone which enables the user to coordinate the various critical operations of the assay including magnetic actuation, thermal incubation, and signal acquisition and processing. The streamlined user interface and training module allow an unexperienced operator to obtain accurate clinical results in approximately 1 hour
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