Dataset Information

Rapid, Quantitative, and Ultrasensitive Point-of-Care Testing: A Portable SERS Reader for Lateral Flow Assays in Clinical Chemistry.

ABSTRACT: The design of a portable Raman/SERS-LFA reader with line illumination using a custom-made fiber optic probe for rapid, quantitative, and ultrasensitive point-of-care testing (POCT) is presented. The pregnancy hormone human chorionic gonadotropin (hCG) is detectable in clinical samples within only 2-5?s down to approximately 1.6?mIU?mL^-1 . This acquisition time is several orders of magnitude shorter than those of existing approaches requiring expensive Raman instrumentation, and the method is 15-times more sensitive than a commercially available lateral flow assay (LFA) as the gold standard. The SERS-LFA technology paves the way for affordable, quantitative, and ultrasensitive POCT with multiplexing potential in real-world applications, ranging from clinical chemistry to food and environmental analysis as well as drug and biowarfare agent testing.

SUBMITTER: Tran V

PROVIDER: S-EPMC6582447 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Rapid, Quantitative, and Ultrasensitive Point-of-Care Testing: A Portable SERS Reader for Lateral Flow Assays in Clinical Chemistry.

Tran Vi V Walkenfort Bernd B König Matthias M Salehi Mohammad M Schlücker Sebastian S

Angewandte Chemie (International ed. in English) 20181108 2

The design of a portable Raman/SERS-LFA reader with line illumination using a custom-made fiber optic probe for rapid, quantitative, and ultrasensitive point-of-care testing (POCT) is presented. The pregnancy hormone human chorionic gonadotropin (hCG) is detectable in clinical samples within only 2-5 s down to approximately 1.6 mIU mL<sup>-1</sup> . This acquisition time is several orders of magnitude shorter than those of existing approaches requiring expensive Raman instrumentation, and the me ...[more]

PMID: 30288886

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Project description:ObjectiveThere is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests (POCTs) and (2) examine the implications of these findings on real-world settings.DesignWe used a content analysis methodology in two stages to systematically, code and analyse textual data from documents of commercial manufacturers. A deductive approach was applied using a coding guide based on the validated Point-of-Care Key Evidence Tool (POCKET) multidimensional checklist. An inductive approach was used to identify new patterns or themes generated from our textual analysis.SettingPublicly available supportive information documents by commercial manufacturers for lateral flow serology, were identified and gathered from online searches.ParticipantsSupportive information documents retrieved from online searches over 3 months (March 2020 to June 2020).ResultsA total of 79 POCTs were identified that met the study inclusion criteria. Using the POCKET coding guide, we found that the quality of information varied significantly between the manufacturers and was often lacking in detail. Our inductive approach further examined these topics and found that several statements were vague and that significant variations in the level of details existed between manufacturers.ConclusionsThis study revealed significant concerns surrounding the supportive information reported by manufacturers for lateral flow serology assays. Information transparency was poor and human factor issues were not properly addressed to mitigate the risk of improper device use, although it should be noted that the results of our study are limited by the data that manufactures were prepared to disclose. Overall, commercial manufacturers should improve the quality and value of information presented in their supporting documentation.

Project description:Severe fever with thrombocytopenia syndrome (SFTS) is a prevalent, life-threatening, emergent infectious disease. Currently, reverse transcription-polymerase chain reaction is the gold standard for diagnosing SFTS virus (SFTSV) infection, which requires sophisticated equipment and professional personnel that are frequently unavailable in most SFTS endemic rural areas. Here, we reported a simple, rapid nucleic acid amplification system that combined the catalytic hairpin assembly (CHA) with a lateral flow immunoassay (LFIA) strip-based detection method for SFTSV detection. The detection of SFTSV RNA could be realized by generation of H1-H2 hybrid duplexes labeled with biotin and digoxin, which subsequently added to the LFIA test strips containing streptavidin conjugated with Alexa Fluor 647 as well as anti-digoxin antibodies. Our CHA-based LFIA assay offered high amplification efficiency and specificity with a detection limit of 1 aM. Crucially, this method enabled stable detection of 500 copies/mL of SFTSV within 30 min using clinical serum samples. Therefore, our CHA-based LFIA approach provided a potential useful tool to facilitate early and precise diagnosis of SFTS patients in poorly resourced SFTS endemic areas.IMPORTANCESevere fever with thrombocytopenia syndrome (SFTS) is an emerging and potentially fatal infectious disease prevalent in China. Here we report a simple, rapid nucleic acid amplification system, the catalytic hairpin assembly (CHA) in conjunction with a lateral flow immunoassay (LFIA) strip-based detection method for SFTS virus detection, which demonstrated high amplification efficiency and specificity with limit of detection of 1 aM. Most importantly, we also validate our CHA-based LFIA assay using the clinical serum samples, which was fully compatible with reverse transcription-PCR results. Therefore, our strategy provides a potential useful tool to facilitate early and precise diagnosis of SFTS patients especially in poorly resourced SFTS endemic areas.

Dataset Information

Rapid, Quantitative, and Ultrasensitive Point-of-Care Testing: A Portable SERS Reader for Lateral Flow Assays in Clinical Chemistry.

Publications

Rapid, Quantitative, and Ultrasensitive Point-of-Care Testing: A Portable SERS Reader for Lateral Flow Assays in Clinical Chemistry.

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