Clinical performance and potential of a SARS-CoV-2 detection kit without RNA purification steps

Abstract Objectives Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is rapidly spreading globally. Early diagnosis plays an essential role in controlling the infection. Therefore, early and accurate SARS-CoV-2 detection assays along with easy operation are required. The aim of this study was to compare the clinical performance of the Ampdirect™ 2019-nCoV Detection Kit (SHIMADZU assay), which does not require RNA purification steps, with that of the preexisting SARS-CoV-2 detection assays, which use a purified RNA template. Methods A total of 71 samples (65 nasopharyngeal specimens and 6 sputum specimens) were collected from 32 individuals, including patients infected with SARS-CoV-2 and those with suspected infection. The sensitivity and kappa (κ) coefficient were assessed between the SARS-CoV-2 detection assays using the reference standard, which was defined as a true positive result by any one of the four SARS-CoV-2 detection assays. Results The overall sensitivity and κ coefficient of the SHIMADZU assay were 86.0% (95% confidence interval [CI]: 77.9–94.2) and 0.83 (95% CI: 0.69–0.96), respectively. In particular, among the 18 samples collected within 10 days from symptom onset, the sensitivity and κ coefficient of the SHIMADZU assay were 100% and 1.0, respectively. Conclusions Although a relatively small number of samples was evaluated, the SHIMADZU assay showed good analytical performance and as such would be highly useful for the detection of SARS-CoV-2. The test can be performed easily and quickly and has the potential for future applications in situations where a highly sensitive diagnosis is required.

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Application progress of magnetic molecularly imprinted polymer chemical sensors in the detection of biomarkers

The Analyst ◽

10.1039/d1an01112j ◽

2022 ◽

Author(s):

Ying Wang ◽

Xiaomin Yang ◽

Lin Pang ◽

Pengfei Geng ◽

Fang Mi ◽

...

Keyword(s):

Chemical Sensors ◽

Molecularly Imprinted Polymers ◽

Essential Role ◽

Imprinted Polymer ◽

Molecularly Imprinted ◽

Magnetic Molecularly Imprinted Polymer ◽

Magnetic Molecularly Imprinted Polymers ◽

Highly Sensitive ◽

Detection Of Biomarkers ◽

Highly Sensitive Detection

Specific recognition and highly sensitive detection of biomarkers play an essential role in identifying, early diagnosis and prevention of many diseases. Magnetic molecularly imprinted polymers (MMIP) have been widely used...

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A highly sensitive self assembled monolayer modified copper doped zinc oxide nanofiber interface for detection of Plasmodium falciparum histidine-rich protein-2: Targeted towards rapid, early diagnosis of malaria

Biosensors and Bioelectronics ◽

10.1016/j.bios.2016.01.036 ◽

2016 ◽

Vol 80 ◽

pp. 39-46 ◽

Cited By ~ 46

Author(s):

K. Brince Paul ◽

Sanni Kumar ◽

Suryasnata Tripathy ◽

Siva Rama Krishna Vanjari ◽

Vikrant Singh ◽

...

Keyword(s):

Zinc Oxide ◽

Plasmodium Falciparum ◽

Early Diagnosis ◽

Self Assembled Monolayer ◽

Highly Sensitive ◽

Self Assembled

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A highly sensitive multiplex biomarker assay for the early diagnosis of osteoarthritis

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2019.02.161 ◽

2019 ◽

Vol 27 ◽

pp. S108 ◽

Cited By ~ 1

Author(s):

J. Hendriks ◽

M. Sharif ◽

D.B. Saris ◽

M. Karperien

Keyword(s):

Early Diagnosis ◽

Highly Sensitive

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Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2

Journal of Clinical Microbiology ◽

10.1128/jcm.00783-20 ◽

2020 ◽

Vol 58 (8) ◽

Cited By ~ 68

Author(s):

Wei Zhen ◽

Elizabeth Smith ◽

Ryhana Manji ◽

Deborah Schron ◽

Gregory J. Berry

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Drug Administration ◽

Clinical Evaluation ◽

Limit Of Detection ◽

Clinical Performance ◽

Molecular Diagnostic ◽

Analytical Sensitivity ◽

Reference Standard ◽

Slight Improvement ◽

Percent Agreement

ABSTRACT Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW COVID-19 [ID NOW], and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (∼17 min) compared to Xpert Xpress (∼46 min) and ePlex (∼1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms.

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Design and Validation of Transcription-Mediated-Amplification Nucleic Acid Amplification Tests forMycoplasma genitalium

Journal of Clinical Microbiology ◽

10.1128/jcm.00264-19 ◽

2019 ◽

Vol 57 (8) ◽

Cited By ~ 9

Author(s):

Brett Kirkconnell ◽

Barbara Weinbaum ◽

Katherine Santos ◽

Trisha Le Nguyen ◽

Bryan Vinluan ◽

...

Keyword(s):

Clinical Performance ◽

Mycoplasma Genitalium ◽

Vaginal Swab ◽

Nucleic Acid Amplification ◽

Clinical Validation ◽

Analytical Sensitivity ◽

Reference Standard ◽

Content Type ◽

Sensitivity Specificity

ABSTRACTMycoplasma genitaliumis a sexually transmitted bacterium linked to adverse sexual and reproductive health outcomes in women and men.M. genitaliumis difficult to culture, and in the absence of validated amplified molecular methods for diagnosis of infection, there is no reference standard available for use as a comparator for the validation of newM. genitaliumdiagnostic tests. We evaluated the analytical and clinical performance of three transcription-mediated amplification (TMA) tests forM. genitalium, each targeting unique rRNA sequences, for use as a composite comparator for clinical validation of the AptimaMycoplasma genitalium(AMG) assay, anin vitrodiagnostic (IVD) TMA test that targets 16 s rRNA ofM. genitalium. Analytical sensitivity, specificity, and strain inclusivity of all four TMA tests were determined using nine laboratory strains ofM. genitaliumand 56 nontarget bacteria, protozoa, and viruses. Analytical sensitivity of the tests forM. genitaliumranged from 0.017 to 0.040 genome equivalents/ml. None of the nontarget organisms evaluated cross-reacted with any test. A composite comparator reference standard consisting of the 3 alternate (Alt) TMA tests was used to evaluate the clinical performance of the AMG assay by testing residual vaginal swab, female urine, and male urine specimens obtained from 1,400 adult subjects from three U.S. clinical sites. Using this reference standard to establish infected specimen status, the sensitivity, specificity, and overall agreement of the AMG IVD assay were 100%, 99.9%, and 99.9%, respectively. These results demonstrate the utility of molecular composite reference standard methodology for the clinical validation of future IVD tests for this organism.

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Early Diagnosis of Medullary Thyroid Cancer: Are Calcitonin Stimulation Tests Still Indicated in the Era of Highly Sensitive Calcitonin Immunoassays?

Thyroid ◽

10.1089/thy.2019.0785 ◽

2020 ◽

Vol 30 (7) ◽

pp. 974-984 ◽

Cited By ~ 3

Author(s):

Martin B. Niederle ◽

Christian Scheuba ◽

Philipp Riss ◽

Andreas Selberherr ◽

Oskar Koperek ◽

...

Keyword(s):

Thyroid Cancer ◽

Early Diagnosis ◽

Medullary Thyroid Cancer ◽

Medullary Thyroid ◽

Highly Sensitive ◽

Stimulation Tests

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Diagnostic performance of a new highly sensitive thyroglobulin immunoassay

Journal of Endocrinology ◽

10.1677/joe.0.1820287 ◽

2004 ◽

Vol 182 (2) ◽

pp. 287-294 ◽

Cited By ~ 37

Author(s):

A Iervasi ◽

G Iervasi ◽

A Bottoni ◽

G Boni ◽

C Annicchiarico ◽

...

Keyword(s):

Clinical Performance ◽

Thyroid Tissue ◽

Cancer Recurrence ◽

Analytical Sensitivity ◽

Serum Thyroglobulin ◽

Coefficients Of Variation ◽

Highly Sensitive ◽

Chemiluminescent Immunoassay ◽

Free Serum

The determination of serum thyroglobulin (Tg) is commonly used for detecting the presence of residual thyroid tissue or cancer recurrence in patients treated for differentiated thyroid cancer (DTC). The aim of the study was to evaluate the performance characteristics of a recently introduced fully automated chemiluminescent immunoassay, based on four monoclonal antibodies and which produces results in 40 min. Analytical sensitivity (0.01 micro g/l) was computed from 20 replicates of the zero calibrator and of the 'Tg-free' sample pool. Functional sensitivity (0.1 micro g/l at 20 coefficients of variation percent) was determined from the imprecision profile obtained by assaying ten serum pools. The reliability of the measurements in the low concentration range (Tg<1 micro g/l) has been checked by progressive dilution with the 'Tg-free' serum of a sample pool at 5.27 micro g/l; measured values were very close to the expected values (recovery 100-133%).Cut-off at the 99th percentile in DTC stage I 'disease-free' treated patients (n=53) was 0.16 micro g/l. Tg measurement in basal conditions during L-thyroxine suppression therapy and 5 days after recombinant human TSH stimulation was performed in 22 patients with DTC. In 80% of patients with basal Tg<0.1 micro g/l (12/15), Tg remained<0.1 micro g/l after stimulation, and in all of these Tg was<1 micro g/l.Our results have indicated the optimal analytical and clinical performance of this Tg immunoassay and encourage further studies on larger populations of patients with DTC.

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A highly sensitive chemiluminescence method for early diagnosis of radiation damage

10.1117/12.572441 ◽

2004 ◽

Author(s):

Yadong Wei ◽

Da Xing ◽

Debin Zhu ◽

Yonghong He ◽

Hongbo Fu

Keyword(s):

Early Diagnosis ◽

Radiation Damage ◽

Chemiluminescence Method ◽

Highly Sensitive

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Role of presepsin for the evaluation of sepsis in the emergency department

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2014-0199 ◽

2014 ◽

Vol 0 (0) ◽

Cited By ~ 2

Author(s):

Elisa Pizzolato ◽

Marco Ulla ◽

Claudia Galluzzo ◽

Manuela Lucchiari ◽

Tilde Manetta ◽

...

Keyword(s):

Emergency Department ◽

Septic Shock ◽

Early Diagnosis ◽

Bacterial Infections ◽

Acute Phase Proteins ◽

Great Sensitivity ◽

Healthy Population ◽

Suspected Sepsis ◽

Gold Standard Method ◽

Suspected Infection

AbstractSepsis, severe sepsis and septic shock are among the most common conditions handled in the emergency department (ED). According to new Sepsis Guidelines, early diagnosis and treatment are the keys to improve survival. Plasma C-reactive protein (CRP) and procalcitonin (PCT) levels, when associated with documented or suspected infection, are now part of the definitions of sepsis. Blood culture is the gold standard method for detecting microorganisms but it requires too much time for results to be known. Sensitive biomarkers are required for early diagnosis and as indexes of prognosis sepsis. CRP is one of the acute phase proteins synthesized by the liver: it has a great sensitivity but a very poor specificity for bacterial infections. Moreover, the evolution of sepsis does not correlate with CRP plasma changes. In recent years PCT has been widely used for sepsis differential diagnosis, because of its close correlation with infections, but it still retains some limitations and false positivity (such as in multiple trauma and burns). Soluble CD14 subtype (sCD14-ST), also known as presepsin, is a novel and promising biomarker that has been shown to increase significantly in patients with sepsis, in comparison to the healthy population. Studies pointed out the capability of this biomarker for diagnosing sepsis, assessing the severity of the disease and providing a prognostic evaluation of patient outcome. In this mini review we mainly focused on presepsin: we evaluate its diagnostic and prognostic roles in patients presenting to the ED with systemic inflammatory response syndrome (SIRS), suspected sepsis or septic shock.

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