Qualitative Immunoassay—Features and Design

He, Jiayuan; Parker, Simon

doi:10.1016/b978-0-08-097037-0.00010-5

Cited by 2 publications

(4 citation statements)

References 33 publications

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“…Specifically, a low concentration was selected that is close to the detection limit (37.0 ng/mL), a mid-range level (147.0 ng/mL), as well as a high concentration that is at the tail end of the linear portion of the assay (440.0 ng/mL). All percent recoveries are within the ±20% clinically accepted values indicating very high accuracy for our VLY assay and are found in Table as Recovery Min, Recovery Med, and Recovery Max …”

Section: Resultssupporting

confidence: 62%

“…All percent recoveries are within the ±20% clinically accepted values indicating very high accuracy for our VLY assay and are found in Table 1 as Recovery Min, Recovery Med, and Recovery Max. 33 The precision of the assay was calculated by measuring the same three concentrations that were described above and calculating the CV for each CV Min, CV Med, and CV Max that correspond to concentrations 37.0, 147.0, and 440.0 ng/ mL, respectively. Data are an average of six measurements on five separate days ± 1 standard deviation.…”

Section: ■ Results and Discussionmentioning

confidence: 99%

“…The assay validation data are summarized in Table 1. The precision of the data was only calculated for the linear portion of the calibration curve as described by He et al 33 Following immunoassay validation, patient samples were tested in duplicates using the developed ELISA. Swabs were collected from female patients (n = 16) and processed as described in the Materials and Methods section.…”

Section: ■ Results and Discussionmentioning

confidence: 99%

“…The assay validation data are summarized in Table . The precision of the data was only calculated for the linear portion of the calibration curve as described by He et al…”

Section: Resultsmentioning

confidence: 99%

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Rapid Point-of-Care Test Kit for Bacterial Vaginosis: Detection of Vaginolysin and Clue Cells Using Paper Strips and a Smartphone

et al. 2022

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There is an unmet need for a point-of-care test that is accurate, affordable, and simple to diagnose bacterial vaginosis, the most common cause of vaginal symptoms among women. Bacterial vaginosis leaves patients with undesirable vaginal discharge, malodor, and discomfort. Currently, the diagnosis of bacterial vaginosis is inaccurate and complex, leading to high rates of misdiagnosis. Inaccurate diagnoses are unsafe as bacterial vaginosis increases the risks of acquiring sexually transmitted infections as well as the likelihood of miscarriages. To date, the most commonly identified bacteria associated with bacterial vaginosis is Gardnerella vaginalis. We developed a method for the expression, purification, and detection of vaginolysin, the most well-characterized virulence factor of G. vaginalis. Elevated levels of G. vaginalis have been shown to lead to a toxic vaginal environment, facilitating bacterial vaginosis. We have developed an enzyme-linked immunosorbent assay for the detection of vaginolysin, which was translated to a lateral flow assay for use in a rapid, straightforward, cost-effective paper-based diagnostic test for vaginolysin that does not require the use of instrumentation. In conjunction, we have employed a commercially available smartphone microscopy kit to visualize clue cells without the need for equipment or electricity. The combination of these methodologies allows for an accurate and easy approach to diagnose bacterial vaginosis with minimal resources for use in any setting.

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Section: Resultssupporting

confidence: 62%

Section: ■ Results and Discussionmentioning

confidence: 99%

Section: ■ Results and Discussionmentioning

confidence: 99%

“…The assay validation data are summarized in Table . The precision of the data was only calculated for the linear portion of the calibration curve as described by He et al…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Rapid Point-of-Care Test Kit for Bacterial Vaginosis: Detection of Vaginolysin and Clue Cells Using Paper Strips and a Smartphone

et al. 2022

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A smartphone dongle for diagnosis of infectious diseases at the point of care

et al. 2015

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This work demonstrates that a full laboratory-quality immunoassay can be run on a smartphone accessory. This low-cost dongle replicates all mechanical, optical, and electronic functions of a laboratory-based enzyme-linked immunosorbent assay (ELISA) without requiring any stored energy; all necessary power is drawn from a smartphone. Rwandan health care workers used the dongle to test whole blood obtained via fingerprick from 96 patients enrolling into care at prevention of mother-to-child transmission clinics or voluntary counseling and testing centers. The dongle performed a triplexed immunoassay not currently available in a single test format: HIV antibody, treponemal-specific antibody for syphilis, and nontreponemal antibody for active syphilis infection. In a blinded experiment, health care workers obtained diagnostic results in 15 min from our triplex test that rivaled the gold standard of laboratory-based HIV ELISA and rapid plasma reagin (a screening test for syphilis), with sensitivity of 92 to 100% and specificity of 79 to 100%, consistent with needs of current clinical algorithms. Patient preference for the dongle was 97% compared to laboratory-based tests, with most pointing to the convenience of obtaining quick results with a single fingerprick. This work suggests that coupling microfluidics with recent advances in consumer electronics can make certain laboratory-based diagnostics accessible to almost any population with access to smartphones.

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Qualitative Immunoassay—Features and Design

Cited by 2 publications

References 33 publications

Rapid Point-of-Care Test Kit for Bacterial Vaginosis: Detection of Vaginolysin and Clue Cells Using Paper Strips and a Smartphone

Rapid Point-of-Care Test Kit for Bacterial Vaginosis: Detection of Vaginolysin and Clue Cells Using Paper Strips and a Smartphone

A smartphone dongle for diagnosis of infectious diseases at the point of care

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