N/A N=272 Collection and Testing of Respiratory Samples
QIAGEN ResPlex II Advanced Panel · Influenza A · Respiratory Syncytial Virus Infections
Primary: Detection of Respiratory Viruses — 83 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=360 Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway
Viral Infection · Acute Respiratory Infection · Upper Resp Tract Infection
Primary: Satisfaction With Time to Receive Result — 180; 53; 3; 72 participants
N/A N=877 Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
COVID-19
Primary: Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test — 130 Participants
N/A N=1,862 Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
Chlamydia Trachomatis · Neisseria Gonorrhoeae Infection
Primary: APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type — 104; 18; 3; 1149 participants
N/A N=1,545 Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
Infectious Gastroenteritis
Primary: Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel — 434; 19 Participants
N/A N=2,124 Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
Pneumonia
Primary: Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing — 91.4…
N/A N=300 Clinical Protocol SeCore, uTYPE and 3500 Dx System
Human Leukocyte Antigens (HLA)
Primary: All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) — 99.6 percentage of concordant alleles
N/A N=332 COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
SARS-CoV2 Infection · COVID-19
Primary: Positive Percent Agreement — 53; 2 Participants
N/A N=12,550 Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
Herpes Simplex Virus
Primary: Sensitivity of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From the Genital Tract of Non-pregnant Women in STI Clinics, as Compared With HSV Culture…
N/A N=479 Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
Bacteremia · Sepsis
Primary: Time to Optimal Antimicrobial Therapy — 31.1; 117.7; 90.0 hours
N/A N=194 Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Respiratory Tract Infections · Influenza, Human · Common Cold
Primary: Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED — 20; 33 Participants
N/A N=614 SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
SARS-CoV-2 Infection · Influenza A · Influenza B
Primary: Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Positive Percent Agreement Performance Comparison of Candidate Device (Metrix) vs…
N/A N=1,361 Performance Evaluation of the Lucira COVID-19 & Flu Test
COVID-19 · Influenza
Primary: Confirmation That the Lucira COVID-19 & Flu Test Provides Similar Performance to a High Complexity Lab Molecular Diagnostic RT-PCR Assay(s) With Known High Sensitivity…
N/A N=2,295 Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Herpes Simplex
Primary: Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test — 281; 54; 9; 1237 Participants
N/A N=66 Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Tuberculosis
Primary: Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites — 32; 23 Participants
N/A N=200 Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
Influenza, Human
Primary: Number of Participants Prescribed Antibiotics — 39; 32 Participants
N/A N=99 COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability
Sars-CoV-2 Infection · COVID-19
Primary: 30 Candidate Ag Test Self-collections — 53; 0 Participants
N/A N=214 Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort
Encephalitis · Meningitis
Primary: Total Number of Cases With at Least One Provider Response — 98; 58 cases
N/A N=2,767 Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
Neisseria Gonorrhoeae Infection · Chlamydia Trachomatis Infection · Sexually Transmitted Infections
Primary: Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria…
N/A N=45 A Study of the GRIP Influenza and SARS-CoV-2 POC Assays
COVID-19 · Influenza
Primary: Positive Percent Agreement — 52 percent of nasal swabs
N/A N=4,561 Influenza Resistance Information Study
Influenza
Primary: Number of Participants With Genotypic Resistance — 44; 1; 0; 2 participants
N/A N=11 Rutgers Pilot for PREDICT- Patient LAB Test
SARS-CoV2 Infection
Primary: Patient Willingness to Participate in the Study — 30 percentage
N/A N=17,987 Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
Healthy
Primary: Alinity s HBsAg Assay Specificity — 16985; 6; 2 Participants
N/A N=419 Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
HIV
Primary: Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis — 100; 99.06; 95.83 Percentage of True Results
N/A N=16,388 Alinity s Anti-HCV II - Clinical Evaluation Protocol
Healthy
Primary: Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. — 15,506; 6; 14 Specimen
N/A N=40 Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
COVID19
Primary: Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result — 18; 17; 22; 23 participants
N/A N=128 A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Conjunctivitis
Primary: Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. — 90; 96 percentage of cases
N/A N=500 Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
Gram-negative Bacteremia
Primary: Hours to First Antibiotic Modification — 24.7; 19.0 hours — p=0.013
N/A N=464 Repeat Testing for SARS-CoV-2
COVID-19 · Sars-CoV-2
Primary: Number of Participant Phone Surveys Conducted — 3 phone surveys
N/A N=8 Spartan FRX Project Reproducibility Study
Analytical Reproducibility of a Medical Device
Primary: Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System. — 98.3; 100; 97.5; 99.2 Percentage of Correct Calls