Real-Time Assay Evaluated for Two Sexually Transmitted Diseases
|
By LabMedica International staff writers Posted on 21 Apr 2020 |
|
Image: The Abbott RealTime CT/NG assay provides detection of Chlamydia trachomatis and Neisseria gonorrhoeae with proven clinical performance in sexually transmitted disease testing (Photo courtesy of Abbott Laboratories).
Chlamydia trachomatis and Neisseria gonorrhoeae are the two most commonly reported sexually transmitted infections (STIs) in the USA and the numbers of cases are increasing. C. trachomatis and N. gonorrhoeae infections in the rectum and pharynx are important extragenital reservoirs of infection.
Due to their high sensitivity and specificity, nucleic acid amplification tests (NAATs) have become the recommended method for detecting N. gonorrhoeae and C. trachomatis infections of the urogenital tract. The Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA) recommends screening of all sexually-active men who have sex with men (MSM) for rectal C. trachomatis and N. gonorrhoeae infections and pharyngeal N. gonorrhoeae, at least annually.
Scientists from the David Geffen School of Medicine (Los Angeles, CA, USA) examined the analytical performance of the Abbott RealTime CT/NG assay (Abbott Laboratories, Abbott Park, IL, USA), including the limit of detection, inclusivity, and analytical specificity for C. trachomatis and N. gonorrhoeae in rectal and pharyngeal specimens. All tests were performed on the Abbott m2000 RealTime system. Elementary Bodies (EB)/mL for C. trachomatis and colony-forming units (CFU)/mL for N. gonorrhoeae, in clinical rectal and pharyngeal swab matrices were measured. Inclusivity was performed against 12 serovars of C. trachomatis and seven strains of N. gonorrhoeae. The analytical specificity was performed using 28 different bacteria and viruses.
The limit of detection for C. trachomatis was 2.56 EB/mL in pharyngeal specimens and 12.8 EB/mL in rectal specimens. The limit of detection for N. gonorrhoeae was 0.0256 CFU/mL for both pharyngeal and rectal specimens. The inclusivity and analytical specificity were 100% for both rectal and pharyngeal specimens. In total, there were 80 specimens tested by the second laboratory. All 40 rectal and pharyngeal specimens spiked with C. trachomatis and all 40 rectal and pharyngeal specimens spiked with N. gonorrhoeae tested positive. C. trachomatis was detected in 0/20 of the N. gonorrhoeae-spiked samples from each anatomic site and N. gonorrhoeae was detected in 0/20 C. trachomatis-spiked samples from each anatomic site.
The authors concluded that their analytical performance data demonstrate that the Abbott CT/NG RealTime assay is an accurate, sensitive, and specific assay in rectal and pharyngeal specimens, supporting the potential of the assay for detection of rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections. The study was published on April 2, 2020 in The Journal of Molecular Diagnostics.
Due to their high sensitivity and specificity, nucleic acid amplification tests (NAATs) have become the recommended method for detecting N. gonorrhoeae and C. trachomatis infections of the urogenital tract. The Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA) recommends screening of all sexually-active men who have sex with men (MSM) for rectal C. trachomatis and N. gonorrhoeae infections and pharyngeal N. gonorrhoeae, at least annually.
Scientists from the David Geffen School of Medicine (Los Angeles, CA, USA) examined the analytical performance of the Abbott RealTime CT/NG assay (Abbott Laboratories, Abbott Park, IL, USA), including the limit of detection, inclusivity, and analytical specificity for C. trachomatis and N. gonorrhoeae in rectal and pharyngeal specimens. All tests were performed on the Abbott m2000 RealTime system. Elementary Bodies (EB)/mL for C. trachomatis and colony-forming units (CFU)/mL for N. gonorrhoeae, in clinical rectal and pharyngeal swab matrices were measured. Inclusivity was performed against 12 serovars of C. trachomatis and seven strains of N. gonorrhoeae. The analytical specificity was performed using 28 different bacteria and viruses.
The limit of detection for C. trachomatis was 2.56 EB/mL in pharyngeal specimens and 12.8 EB/mL in rectal specimens. The limit of detection for N. gonorrhoeae was 0.0256 CFU/mL for both pharyngeal and rectal specimens. The inclusivity and analytical specificity were 100% for both rectal and pharyngeal specimens. In total, there were 80 specimens tested by the second laboratory. All 40 rectal and pharyngeal specimens spiked with C. trachomatis and all 40 rectal and pharyngeal specimens spiked with N. gonorrhoeae tested positive. C. trachomatis was detected in 0/20 of the N. gonorrhoeae-spiked samples from each anatomic site and N. gonorrhoeae was detected in 0/20 C. trachomatis-spiked samples from each anatomic site.
The authors concluded that their analytical performance data demonstrate that the Abbott CT/NG RealTime assay is an accurate, sensitive, and specific assay in rectal and pharyngeal specimens, supporting the potential of the assay for detection of rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections. The study was published on April 2, 2020 in The Journal of Molecular Diagnostics.
Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Complement 3 (C3) Test
GPP-100 C3 Kit
Gold Member
Systemic Autoimmune Testing Assay
BioPlex 2200 ANA Screen with MDSS
Latest Microbiology News
- New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier
- 1 Hour, Direct-From-Blood Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens
- Mouth Bacteria Test Could Predict Colon Cancer Progression
- Unique Metabolic Signature Could Enable Sepsis Diagnosis within One Hour of Blood Collection
- Groundbreaking Diagnostic Platform Provides AST Results With Unprecedented Speed
- Simple Blood Test Combined With Personalized Risk Model Improves Sepsis Diagnosis
- Blood Analysis Predicts Sepsis and Organ Failure in Children
- TB Blood Test Could Detect Millions of Silent Spreaders
- New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours
- New Tuberculosis Test to Expand Testing Access in Low- and Middle-Income Countries
- Rapid Test Diagnoses Tropical Disease within Hours for Faster Antibiotics Treatment
- Rapid Molecular Testing Enables Faster, More Targeted Antibiotic Treatment for Pneumonia
- Rapid AST Platform Provides Targeted Therapeutic Results Days Faster Than Current Standard of Care
- New Analysis Method Detects Pathogens in Blood Faster and More Accurately by Melting DNA
- Rapid Sepsis Test Delivers Two Days Faster Results
- Portable Rapid PCR Diagnostic to Detect Gonorrhea and Antibiotic Susceptibility
Channels
Clinical Chemistry
view channel
3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models
Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more.jpg "Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)")
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more
Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases
The conventional methods for measuring free cortisol, the body's stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting... Read more
Hematology
view channel
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns
Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections
Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West... Read more
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy
Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read moreImmunology
view channel
Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies
Transplanted organs constantly face the risk of being rejected by the recipient's immune system which differentiates self from non-self using T cells and B cells. T cells are commonly associated with acute... Read more
AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample.... Read more
Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment
Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means... Read more
Microbiology
view channel
New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier
According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver... Read more
1 Hour, Direct-From-Blood Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens
Sepsis contributes to one in every three hospital deaths in the US, and globally, septic shock carries a mortality rate of 30-40%. Diagnosing sepsis early is challenging due to its non-specific symptoms... Read more
.jpg "Image: Dr. Sam Lodge found that metabolic signatures can shift the speed of sepsis diagnosis (Photo courtesy of Murdoch University)")
Pathology
view channel
AI-Powered Digital Imaging System to Revolutionize Cancer Diagnosis
The process of biopsy is important for confirming the presence of cancer. In the conventional histopathology technique, tissue is excised, sliced, stained, mounted on slides, and examined under a microscope... Read more
New Mycobacterium Tuberculosis Panel to Support Real-Time Surveillance and Combat Antimicrobial Resistance
Tuberculosis (TB), the leading cause of death from an infectious disease globally, is a contagious bacterial infection that primarily spreads through the coughing of patients with active pulmonary TB.... Read more
Technology
view channel
New Diagnostic System Achieves PCR Testing Accuracy
While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex... Read more
DNA Biosensor Enables Early Diagnosis of Cervical Cancer
Molybdenum disulfide (MoS2), recognized for its potential to form two-dimensional nanosheets like graphene, is a material that's increasingly catching the eye of the scientific community.... Read more
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples
Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids.... Read more
Breakthrough in Diagnostic Technology Could Make On-The-Spot Testing Widely Accessible
Home testing gained significant importance during the COVID-19 pandemic, yet the availability of rapid tests is limited, and most of them can only drive one liquid across the strip, leading to continued... Read moreIndustry
view channel
ECCMID Congress Name Changes to ESCMID Global
Over the last few years, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID, Basel, Switzerland) has evolved remarkably. The society is now stronger and broader than ever before... Read more
Bosch and Randox Partner to Make Strategic Investment in Vivalytic Analysis Platform
Given the presence of so many diseases, determining whether a patient is presenting the symptoms of a simple cold, the flu, or something as severe as life-threatening meningitis is usually only possible... Read more
Siemens to Close Fast Track Diagnostics Business
Siemens Healthineers (Erlangen, Germany) has announced its intention to close its Fast Track Diagnostics unit, a small collection of polymerase chain reaction (PCR) testing products that is part of the... Read more