Clinical Diagnostics

Find the latest research on a wide range of molecular and serological assays currently available or under development:

1. Detection of Virus and Its Components (including Molecular Diagnostics)
2. Serology (including Neutralization)

October 2020

• *NEW A pooled testing strategy for identifying SARS-CoV-2 at low prevalence.
• The Effect of Sample Site, Illness Duration, and the Presence of Pneumonia on the Detection of SARS-CoV-2 by Real-time Reverse Transcription PCR.
• Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study.
• Hitting the diagnostic sweet spot: Point-of-care SARS-CoV-2 salivary antigen testing with an off-the-shelf glucometer.
• *Research Tool Massive and rapid COVID-19 testing is feasible by extraction-free SARS-CoV-2 RT-PCR.

September 2020

• Swab-Seq: A high-throughput platform for massively scaled up SARS-CoV-2 testing.
• Digital droplet PCR accurately quantifies SARS-CoV-2 viral load from crude lysate without nucleic acid purification.
• SARS-CoV-2 identification and IgA antibodies in saliva: one sample two tests approach for diagnosis.
• Sensitive fluorescence detection of SARS-CoV-2 RNA in clinical samples via one-pot isothermal ligation and transcription.
• Ultrasensitive and visual detection of SARS-CoV-2 using all-in-one dual CRISPR-Cas12a assay.
• Saliva as a Candidate for COVID-19 Diagnostic Testing: A Meta-Analysis.
• A role for Biofoundries in rapid development and validation of automated SARS-CoV-2 clinical diagnostics.
• Efficient high-throughput SARS-CoV-2 testing to detect asymptomatic carriers.
• Self-collected Saline Gargle Samples as an Alternative to Healthcare Worker Collected Nasopharyngeal Swabs for COVID-19 Diagnosis in Outpatients.
• Detection of SARS-CoV-2 with SHERLOCK One-Pot Testing.
• Pooling saliva to increase SARS-CoV-2 testing capacity.
• Detection and quantification of SARS-CoV-2 by droplet digital PCR in real-time PCR negative nasopharyngeal swabs from suspected COVID-19 patients.
• Clinical validation of a Cas13-based assay for the detection of SARS-CoV-2 RNA.
• The Interpretation of SARS-CoV-2 Diagnostic Tests.
• SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance.

August 2020

• Saliva sample pooling for the detection of SARS-CoV-2.
• Multiplexed Nanomaterial-Based Sensor Array for Detection of COVID-19 in Exhaled Breath.
• CT Vascular Tree-in-bud: A Novel Prognostic Imaging Biomarker in COVID-19?
• Non-invasive saliva specimens for the diagnosis of COVID-19: caution in mild outpatient cohorts with low prevalence.
• Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection.
• Prospective study comparing deep-throat saliva with other respiratory tract specimens in the diagnosis of novel coronavirus disease (COVID-19).
• Reliability of self-sampling for accurate assessment of respiratory virus viral and immunologic kinetics.
• A Novel Multiplex qRT-PCR Assay to Detect SARS-CoV-2 Infection: High Sensitivity and Increased Testing Capacity.
• A colorimetric RT-LAMP assay and LAMP-sequencing for detecting SARS-CoV-2 RNA in clinical samples.
• Comparison of Unsupervised Home Self-collected Midnasal Swabs With Clinician-Collected Nasopharyngeal Swabs for Detection of SARS-CoV-2 Infection.
• Proteotyping SARS-CoV-2 virus from nasopharyngeal swabs: a proof-of-concept focused on a 3 min mass spectrometry window.
• Saliva Sampling and Its Direct Lysis, an Excellent Option To Increase the Number of SARS-CoV-2 Diagnostic Tests in Settings with Supply Shortages.
• A Recurrent Mutation at Position 26340 of SARS-CoV-2 Is Associated with Failure of the E Gene Quantitative Reverse Transcription-PCR Utilized in a Commercial Dual-Target Diagnostic Assay.

July 2020

• A recurrent mutation at position 26,340 of SARS-CoV-2 is associated with failure of the E-gene qRT-PCR utilized in a commercial dual-target diagnostic assay.
• Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT-qPCR primer-probe sets.
• Use of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios in COVID-19.
• Comparison of two commercial platforms and a laboratory developed test for detection of SARS-CoV-2 RNA.
• Novel multiple swab method enables high efficiency in SARS-CoV-2 screenings without loss of sensitivity for screening of a complete population.
• Advances in Detection of Infectious Agents by Aptamer-based Technologies.
• Deep throat saliva as an alternative diagnostic specimen type for the detection of SARS-CoV-2.
• Utility of Stool PCR for the Diagnosis of COVID-19: Comparison of Two Commercial Platforms.
• Assessment of sample pooling for clinical SARS-CoV-2 testing.
• Simulation of Pool Testing to Identify Patients With Coronavirus Disease 2019 Under Conditions of Limited Test Availability.
• Culture-based virus isolation to evaluate potential infectivity 1 of clinical specimens tested for COVID-19.
• Mass Spectrometric Identification of SARS-CoV-2 Proteins from Gargle Solution Samples of COVID-19 Patients.
• Nanotrap(R) particles improve detection of SARS-CoV-2 for pooled sample methods, extraction-free saliva methods, and extraction-free medium methods.

June 2020

• Evaluation of specimen types and saliva stabilization solutions for SARS-CoV-2 testing.
• Culture-based virus isolation to evaluate potential infectivity of clinical specimens tested for COVID-19.
• Propagation, Inactivation, and Safety Testing of SARS-CoV-2.
• First detection of SARS-CoV-2 by real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay in pleural fluid.
• Clinical Performance of SARS-CoV-2 Molecular Tests.
• Pitfalls in SARS-CoV-2 PCR Diagnostics.
• Field-deployable, rapid diagnostic testing of saliva samples for SARS-CoV-2.
• Clinical evaluation of self-collected saliva by RT-qPCR, direct RT-qPCR, RT-LAMP, and a rapid antigen test to diagnose COVID-19.
• Comparative Performance of SARS-CoV-2 Detection Assays using Seven Different Primer/Probe Sets and One Assay Kit.
• Direct RT-qPCR Detection Of SARS-CoV-2 RNA From Patient Nasopharyngeal Swabs Without An RNA Extraction Step.
• Clinical Performance of the Luminex NxTAG CoV Extended Panel for SARS-CoV-2 Detection in Nasopharyngeal Specimens from COVID-19 Patients in Hong Kong.
• Clinical performance of different SARS-CoV-2 IgG antibody tests.
• Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays.
• Evaluation of rapid diagnosis of novel coronavirus disease (COVID-19) using loop-mediated isothermal amplification.
• Occurrence and Timing of Subsequent SARS-CoV-2 RT-PCR Positivity Among Initially Negative Patients.
• Homogeneous circle-to-circle amplification for real-time optomagnetic detection of SARS-CoV-2 RdRp coding sequence.
• SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays.
• Clinical Performance of SARS-CoV-2 Molecular Testing.
• Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2.
• An Inexpensive RT-PCR Endpoint Diagnostic Assay for SARS-CoV-2 Using Nested PCR: Direct Assessment of Detection Efficiency of RT-qPCR Tests and Suitability for Surveillance.
• Shortlisting SARS-CoV-2 Peptides for Targeted Studies from Experimental Data-Dependent Acquisition Tandem Mass Spectrometry Data.
• Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens.
• Comparison of two commercial molecular tests and a laboratory-developed modification of the CDC 2019-nCoV RT-PCR assay for the detection of SARS-CoV-2.
• SYBR Green-based one-step qRT-PCR for the detection of SARS-CoV-2 RNA in saliva.
• Test Agreement between Roche Cobas 6800 and Cepheid GeneXpert Xpress SARS-CoV-2 Assays at High Cycle Threshold Ranges.
• Implication of SARS-CoV-2 evolution in the sensitivity of RT-qPCR diagnostic assays.
• Improved sensitivity using a dual target, E and RdRp assay for the diagnosis of SARS-CoV-2 infection: Experience at a large NHS Foundation Trust in the UK.
• Two Detailed Plaque Assay Protocols for the Quantification of Infectious SARS-CoV-2.
• Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Media and Dry Nasal Swabs in a New York City Academic Institution.
• Host-Viral Infection Maps Reveal Signatures of Severe COVID-19 Patients.
• Rapid and accurate detection of novel coronavirus SARS-CoV-2 using CRISPR-Cas3.
• Detection of SARS-CoV-2 neutralizing antibodies with a cell-free PCR assay.

May 2020

• Analytical comparisons of SARS-COV-2 detection by qRT-PCR and ddPCR with multiple primer/probe sets.
• Validation of SARS-CoV-2 detection across multiple specimen types.
• Phenol-chloroform-based RNA purification for detection of SARS-CoV-2 by RT-qPCR: comparison with automated systems.
• Neutralizing antibody and soluble ACE2 inhibition of a replication-competent VSV-1 SARS-CoV-2 and a clinical isolate of SARS-CoV-2.
• Viral loads in throat and anal swabs in children infected with SARS-CoV-2.
• Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure.
• A multiple center clinical evaluation of an ultra-fast single-tube assay for SARS-CoV-2 RNA.
• Testing Dilemmas: Post negative, positive SARS-CoV-2 RT-PCR – is it a reinfection?
• US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2.
• Performance of the rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution.
• Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.
• Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays.
• Sensitivity assessment of SARS-CoV-2 PCR assays developed by WHO referral laboratories.
• Diagnostic performance between CT and initial real-time RT-PCR for clinically suspected 2019 coronavirus disease (COVID-19) patients outside Wuhan, China.

April 2020

• Development and potential usefulness of the COVID-19 Ag Respi-Strip diagnostic assay in a pandemic context.
• Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the first rapid multiplex PCR commercial assay for SARS-CoV-2 detection.
• Evaluation of Transport Media and Specimen Transport Conditions for the Detection of SARS-CoV-2 Using Real Time Reverse Transcription PCR.
• Evaluation of WHO listed COVID-19 qPCR primers and probe in silico with 375 SERS-CoV-2 full genome sequences.
• A rapid, low cost, and highly sensitive SARS-CoV-2 diagnostic based on whole genome sequencing.
• Clinical Evaluation of Three Sample-To-Answer Platforms for the Detection of SARS-CoV-2.
• Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients.
• Comparison of Commercially Available and Laboratory Developed Assays for in vitro Detection of SARS-CoV-2 in Clinical Laboratories.
• The Detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 Assays.
• Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study.
• Laboratory diagnosis of emerging human coronavirus infections - the state of the art.
• Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of Diagnostic Testing for SARS–CoV-2/COVID-19.
• The Laboratory Diagnosis of COVID-19 Infection: Current Issues and Challenges.
• Emergence of a Novel Coronavirus (COVID-19): Protocol for Extending Surveillance Used by the Royal College of General Practitioners Research and Surveillance Centre and Public Health England.
• Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes.

 

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October 2020

• *NEW A high-throughput microfluidic nano-immunoassay for detecting anti-SARS-CoV-2 antibodies in serum or ultra-low volume dried blood samples.
• *NEW Neutralizing antibody against SARS-CoV-2 spike in COVID-19 patients, health care workers and convalescent plasma donors.
• Application, Verification and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization.
• COVID-19 seroprevalence surveys and antibody decline - A note of caution on antibody decline.
•  Sensitive Detection of SARS-CoV-2-Specific Antibodies in Dried Blood Spot Samples.
• Rapid Determination of SARS-CoV-2 Antibodies Using a Bedside, Point-of-Care, Serological Test.

September 2020

• Competitive SARS-CoV-2 Serology Reveals Most Antibodies Targeting the Spike Receptor-Binding Domain Compete for ACE2 Binding.
• Ultrasensitive high-resolution profiling of early seroconversion in patients with COVID-19.
• Serological Assays Estimate Highly Variable SARS-CoV-2 Neutralizing Antibody Activity in Recovered COVID-19 Patients.
• Comparative performance of five commercially available serologic assays to detect antibodies to SARS-CoV-2 and identify individuals with high neutralizing titers.
• Detection of antibodies against SARS-CoV-2 spike protein by gold nanospikes in an opto-microfluidic chip.
• Evaluation of Abbott Anti-SARS-CoV-2 CMIA IgG and Euroimmun ELISA IgG/IgA Assays In a Clinical Lab.
• A simple protein-based surrogate neutralization assay for SARS-CoV-2.
• Multiplexed Detection and Quantification of Human Antibody Response to COVID-19 Infection Using a Plasmon Enhanced Biosensor Platform.
• Two serological approaches for detection of antibodies to SARS-CoV-2 in different scenarios: a screening tool and a point-of-care test.
• Development and validation of a multiplex bead based assay for the detection of antibodies directed against SARS-CoV-2 proteins.
• SARS-CoV-2 assays to detect functional antibody responses that block ACE2 recognition in vaccinated animals and infected patients.
• Diagnostic significance of SARS-CoV-2 IgM positive/IgG negative antibody profile in symptomatic patients with suspected COVID-19 testing negative by RT-PCR.
• Detection of SARS-CoV-2 IgG by Four Nucleocapsid or Spike Protein-Targeting High-Throughput Immunoassays Authorized for Emergency Use.
• A highly specific and sensitive serological assay detects SARS-CoV-2 antibody levels in COVID-19 patients that correlate with neutralization.
• Multi-species ELISA for the detection of antibodies against SARS-CoV-2 in animals.

August 2020

• High seroprevalence for SARS-CoV-2 among household members of essential workers detected using a dried blood spot assay.
• Engineering luminescent biosensors for point-of-care SARS-CoV-2 antibody detection.
• ORF8 and ORF3b antibodies are accurate serological markers of early and late SARS-CoV-2 infection.
• Evaluation of a novel multiplexed assay for determining IgG levels and functional activity to SARS-CoV-2.
• SARS-CoV-2-specific ELISA development.
• Rapid Screening Evaluation of SARS-CoV-2 IgG Assays Using Z-Scores to Standardize Results.
• Linear B-cell epitopes in the spike and nucleocapsid proteins as markers of SARS-CoV-2 exposure and disease severity.
• Rapid quantitative screening assay for SARS-CoV-2 neutralizing antibodies using HiBiT-tagged virus-like particles.
• Serial Profiling of SARS-CoV-2 Antigens and Antibodies in COVID-19 Patient Plasma.
• A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein-protein interaction.

July 2020

• Rapid and sensitive detection of SARS-CoV-2 antibodies by biolayer interferometry.
• Dynamics and significance of the antibody response to SARS-CoV-2 infection.
• D614G Spike Variant Does Not Alter IgG, IgM, or IgA Spike Seroassay Performance.
• Analytical and clinical validation of an ELISA for specific SARS-CoV-2 IgG, IgA and IgM antibodies.
• Evaluation of six commercial mid to high volume antibody and six point of care lateral flow assays for detection of SARS-CoV-2 antibodies.
• An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment.
• Laboratory Assay Evaluation Demystified: A Review of Key Factors Influencing Interpretation of Test Results Using Different Assays for SARS-CoV-2 Infection Diagnosis.
• Novel SARS-CoV-2 specific antibody and neutralization assays reveal wide range of humoral immune response during COVID-19.
• Multiplex detection and dynamics of IgG antibodies to SARS-CoV2 and the highly pathogenic human coronaviruses SARS-CoV and MERS-CoV.
• Association between neutralizing antibodies to SARS-CoV-2 and commercial serological assays.
• COVID-19 serology at population scale: SARS-CoV-2-specific 2 antibody responses in saliva.
• The COVID-19 Serology Studies Workshop: Recommendations and Challenges.
• Hospital-Wide SARS-CoV-2 Antibody Screening in 3056 Staff in a Tertiary Center in Belgium.
• Development and validation of IMMUNO-COV™: a high-throughput clinical assay for detecting antibodies that neutralize SARS-CoV-2.
• A Digital Protein Microarray for COVID-19 Cytokine Storm Monitoring.
• Measuring SARS-CoV-2 neutralizing antibody activity using pseudotyped and chimeric viruses.

June 2020

• Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation.
• SARS-CoV-2-specific antibody detection for sero-epidemiology: a multiplex analysis approach accounting for accurate seroprevalence.
• When To Retest: an Examination of Repeat COVID-19 PCR Patterns in an Ambulatory Population.
• Identification of immunodominant linear epitopes from SARS-CoV-2 patient plasma.
• Detection of antibodies to the SARS-CoV-2 spike glycoprotein in both serum and saliva enhances detection of infection.
• Serological differentiation between COVID-19 and SARS infections.
• Optimizing high-yield production of SARS-CoV-2 soluble spike trimers for serology assays.
• Seroprevalence of immunoglobulin M and G antibodies against SARS-CoV-2 in China.
• Alltest rapid lateral flow immunoassays is reliable in diagnosing SARS-CoV-2 infection from 14 days after symptom onset: A prospective single-center study.
• A Modular Microarray Imaging System for Highly Specific COVID-19 Antibody Testing.
• Diagnostic performance of 7 rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients.

May 2020

• Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset.
• SARS-CoV-2 seroprevalence and neutralizing activity in donor and patient blood from the San Francisco Bay Area.
• Standardization of enzyme-linked immunosorbent assays for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling.
• Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19.
• A serological assay to detect SARS-CoV-2 seroconversion in humans.
• Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies.
• Clinical Performance of Two SARS-CoV-2 Serologic Assays.
• Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samples.
• Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody.
• Serology assays to manage COVID-19.
• ReScan, a Multiplex Diagnostic Pipeline, Pans Human Sera for SARS-CoV-2 Antigens.
• Rapid isolation of potent SARS-CoV-2 neutralizing antibodies and protection in a small animal model.

April 2020

• Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), March 2020.
• SARS-CoV-2 serological analysis of COVID-19 hospitalized patients, pauci-symptomatic individuals and blood donors.
• Test performance evaluation of SARS-CoV-2 serological assays.
• Detection of Nucleocapsid Antibody to SARS-CoV-2 is More Sensitive than Antibody to Spike Protein in COVID-19 Patients.
• Diagnostic accuracy of an automated chemiluminescent immunoassay for anti-SARS-CoV-2 IgM and IgG antibodies: an Italian experience.
• Rapid Detection of COVID-19 Causative Virus (SARS-CoV-2) in Human Nasopharyngeal Swab Specimens Using Field-Effect Transistor-Based Biosensor.
• Antibody Detection and Dynamic Characteristics in Patients with COVID-19.
• Evaluation of antibody testing for SARS-Cov-2 using ELISA and lateral flow immunoassays.
• The convalescent sera option for containing COVID-19.
• Severe Acute Respiratory Syndrome Coronavirus 2−Specific Antibody Responses in Coronavirus Disease 2019 Patients.
• Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019.
• Evaluation of Nucleocapsid and Spike Protein-based ELISAs for detecting antibodies against SARS-CoV-2.
• Establishment and validation of a pseudovirus neutralization assay for SARS-CoV-2.

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