Improved detection of group A <i>Streptococcus</i> during thermal contrast amplification <i>vs.</i> visual reading of clinical rapid diagnostic tests

Wang, Yiru; Louwagie, Erin Marie; Larkin, D.F.; Sankey, Stephanie; Boulware, David R.; Bischof, John C.

doi:10.1039/c8ay02125b

Cited by 6 publications

(14 citation statements)

References 25 publications

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“…The lower F1 score for the dry results indicates that the dry results are less accurate than the wet results. These results are consistent with our previous findings with group A: Streptococcus LFAs by TCA reading, in which wet LFAs exhibited a slightly higher sensitivity improvement and lower thermal noise than dry LFAs [ 31 ]. Thus, we can expect TCA to give better performance when implemented on wet LFAs following assay completion.…”

Section: Resultssupporting

confidence: 93%

“…Approximately 25% of the visual false negatives for influenza A can be detected as true positive by TCA and approximately 9% for influenza B. This advantage of TCA to pick out visual false negatives is consistent with our preliminary cohort study for group A: Streptococcus diagnostics [ 31 ]. Thus, the results validate the capability of TCA to detect subvisual, weak positives and improve the sensitivity of clinical LFAs.…”

Section: Resultssupporting

confidence: 85%

“…Therefore, a prospective cohort study is needed to evaluate the TCA-LFA diagnostic platform for POC use. Our previous preliminary cohort study [ 31 ] reported that the TCA reader was able to identify ~50% of the false negatives from all 88 false negatives in clinical group A: Streptococcus RIDTs (QuickVue Dipstick Strep A Test, Quidel) against the PCR results. In this study, to further evaluate the TCA reader, a double-blind collaborative clinical cohort study was conducted on influenza A and B RIDTs (QuickVue Influenza A + B Test, Quidel) from a larger cohort of patients ( n = 345) with a local primary care clinic (HealthEast Grand Avenue Clinic, St. Paul, MN, USA).…”

Section: Introductionmentioning

confidence: 99%

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Improved Influenza Diagnostics through Thermal Contrast Amplification

et al. 2021

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Influenza poses a serious health threat and creates an economic burden for people around the world. The accurate diagnosis of influenza is critical to the timely clinical treatment of patients and the control of outbreaks to protect public health. Commercially available rapid influenza diagnostic tests (RIDTs) that are operated by visual readout are widely used in clinics to screen influenza infections, but RIDTs suffer from imperfect analytical sensitivity, especially when the virus concentration in the sample is low. Fortunately, the sensitivity can be simply improved through an add-on signal amplification step, i.e., thermal contrast amplification (TCA). To demonstrate the advantage of TCA for influenza diagnosis, we conducted a prospective cohort study on 345 clinical specimens collected for influenza A and B testing during the 2017–2018 influenza season. All samples were tested using the Quidel QuickVue Influenza A + B test, followed by a TCA readout, and then confirmatory polymerase chain reaction testing. Through the TCA detecting sub-visual weak positives, TCA reading improved the overall influenza sensitivity by 53% for influenza A and 33% for influenza B over the visual RIDTs readings. Even though the specificity was compromised slightly by the TCA protocol (relative decrease of 0.09% for influenza A and 0.01% for influenza B), the overall performance was still better than that achieved by visual readout based on comparison of their plots in receiver operating characteristic space and F1 scores (relative increase of 14.5% for influenza A and 12.5% for influenza B). Performing a TCA readout on wet RIDTs also improved the overall TCA performance (relative increase in F1 score of 48%). Overall, the TCA method is a simple and promising way to improve the diagnostic performance of commercial RIDTs for infectious diseases, especially in the case of specimens with low target analytes.

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Section: Resultssupporting

confidence: 93%

Section: Resultssupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

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Improved Influenza Diagnostics through Thermal Contrast Amplification

et al. 2021

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“…In biomedical diagnosis, an important advantage of this technology is that it enables the decentralization of laboratory testing to POC sites. Some important examples of LFAs are those used for the rapid diagnosis of influenza, , Streptococcus , , and many other viral and bacterial infections. − The Centers for Disease Control and Prevention estimates that 9–45 million influenza infections occur in the United States each year, leading to 140,000–810,000 hospitalizations and 12,000–61,000 deaths per year . Rapid influenza LFA testing provides results within minutes, thus enabling timely clinical decisions and medical treatment.…”

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confidence: 99%

Ultrasensitive and Highly Specific Lateral Flow Assays for Point-of-Care Diagnosis

et al. 2021

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Lateral flow assays (LFAs) are paper-based point-of-care (POC) diagnostic tools that are widely used because of their low cost, ease of use, and rapid format. Unfortunately, traditional commercial LFAs have significantly poorer sensitivities (μM) and specificities than standard laboratory tests (enzyme-linked immunosorbent assay, ELISA: pM−fM; polymerase chain reaction, PCR: aM), thus limiting their impact in disease control. In this Perspective, we review the evolving efforts to increase the sensitivity and specificity of LFAs. Recent work to improve the sensitivity through assay improvement includes optimization of the assay kinetics and signal amplification by either reader systems or additional reagents. Together, these efforts have produced LFAs with ELISA-level sensitivities (pM−fM). In addition, sample preamplification can be applied to both nucleic acids (direct amplification) and other analytes (indirect amplification) prior to LFA testing, which can lead to PCR-level (aM) sensitivity. However, these amplification strategies also increase the detection time and assay complexity, which inhibits the large-scale POC use of LFAs. Perspectives to achieve future rapid (<30 min), ultrasensitive (PCR-level), and "sample-to-answer" POC diagnostics are also provided. In the case of LFA specificity, recent research efforts have focused on high-affinity molecules and assay optimization to reduce nonspecific binding. Furthermore, novel highly specific molecules, such as CRISPR/Cas systems, can be integrated into diagnosis with LFAs to produce not only ultrasensitive but also highly specific POC diagnostics. In summary, with continuing improvements, LFAs may soon offer performance at the POC that is competitive with laboratory techniques while retaining a rapid format.

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“…This improved sensitivity of commercial SARS-CoV-2 antigen LFAs by TCA is also consistent with our previous cohort studies for rapid diagnosis of influenza 43 and group A: Streptococcus . 44 …”

Section: Resultsmentioning

confidence: 99%

fM–aM Detection of the SARS-CoV-2 Antigen by Advanced Lateral Flow Immunoassay Based on Gold Nanospheres

Liu

Zhan

Shen

et al. 2021

ACS Appl. Nano Mater.

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The SARS-CoV-2 global pandemic created an unprecedented need for rapid, sensitive, and inexpensive point-of-care (POC) diagnostic tests to treat and control the disease. Many POC SARS-CoV-2 lateral flow immunoassays (LFAs) have been developed and/or commercialized, but with only limited sensitivity (μM–fM). We created an advanced LFA based on gold nanospheres (GNSs) with comprehensive assay redesign for enhanced specific binding and thermal contrast amplification (TCA) on GNSs for signal amplification, which enabled fM–aM detection sensitivity for SARS-CoV-2 spike receptor-binding domain (RBD) proteins within 30 min. The advanced LFA can visually detect RBD proteins down to 3.6 and 28.6 aM in buffer and human nasopharyngeal wash, respectively. This is the first reported LFA achieving sensitivity comparable to that of the PCR (aM–zM) by visual reading, which was much more sensitive than traditional LFAs. We also developed a fast (<1 min) TCA reading algorithm, with results showing that this TCA could distinguish 26–32% visual false negatives for clinical commercial LFAs. When our advanced LFAs were applied with this TCA, the sensitivities were further improved by eightfold to 0.45 aM (in buffer) and 3.6 aM (in the human nasopharyngeal wash) with a semiquantitative readout. Our proposed advanced LFA with a TCA diagnostic platform can help control the current SARS-CoV-2 pandemic. Furthermore, the simplicity and speed with which this assay was assembled may also facilitate preparedness for future pandemics.

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Improved detection of group A Streptococcus during thermal contrast amplification vs. visual reading of clinical rapid diagnostic tests

Abstract: Group A Streptococcus causes significant health care costs and burdens.

Cited by 6 publications

References 25 publications

Improved Influenza Diagnostics through Thermal Contrast Amplification

Improved Influenza Diagnostics through Thermal Contrast Amplification

Ultrasensitive and Highly Specific Lateral Flow Assays for Point-of-Care Diagnosis

fM–aM Detection of the SARS-CoV-2 Antigen by Advanced Lateral Flow Immunoassay Based on Gold Nanospheres

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