Korean Biopharmaceutical Firm Celltrion Launches Both Antigen and Antibody Testing Kits in the US
|
By LabMedica International staff writers Posted on 13 Aug 2020 |
|
SAMPINUTE™ COVID-19 Antigen MIA (left) and DiaTrust™ COVID-19 IgG/IgM Rapid Test (Photo courtesy of Celltrion)
Celltrion Group (Incheon, Korea) has launched two rapid COVID-19 testing kits, SAMPINUTE COVID-19 Antigen MIA for detection of SARS-CoV-2 antigen, and DiaTrust COVID-19 IgG/IgM Rapid Test for detection of SARS-CoV-2 IgG/IgM antibody in the US.
SAMPINUTE COVID-19 Antigen MIA is an electrochemical immunoassay test for detection of SARS-CoV-2 antigen from nasopharyngeal swab samples, composed of one time use test cartridges and a portable analyzer. DiaTrust COVID-19 IgG/IgM Rapid Test is a one-step in-vitro diagnostic test based on immunochromatographic assay designed for the rapid detection of antibodies of the novel coronavirus in healthcare settings. Both the rapid tests kits have shown a reliable performance and promising clinical trial results. SAMPINUTE COVID-19 Antigen MIA has a sensitivity of 94% and a specificity of 100%, with time to results within 10 minutes. DiaTrust COVID-19 IgG/IgM Rapid Test has also shown a reliable performance with 96% positive percent agreement and 98.67% negative percent agreement for IgM, 92% positive percent agreement and 100% negative percent agreement for IgG. The test has a turnaround time of 15 minutes.
“Celltrion has been striving to bring the tests into the US. The need for more accessible, affordable, and most importantly, rapid diagnostic testing will grow, as the daily activities are coming back, and the economy is opening up again,” a Celltrion representative stated. “With the short turnaround time and promising performance of the sensitivity and specificity results, Celltrion is confident that both SAMPINUTE COVID-19 Antigen MIA and DiaTrust COVID-19 IgG/IgM Rapid Test will add great value to healthcare providers in screening patients and keeping communities safe.”
Related Links:
Celltrion Group
SAMPINUTE COVID-19 Antigen MIA is an electrochemical immunoassay test for detection of SARS-CoV-2 antigen from nasopharyngeal swab samples, composed of one time use test cartridges and a portable analyzer. DiaTrust COVID-19 IgG/IgM Rapid Test is a one-step in-vitro diagnostic test based on immunochromatographic assay designed for the rapid detection of antibodies of the novel coronavirus in healthcare settings. Both the rapid tests kits have shown a reliable performance and promising clinical trial results. SAMPINUTE COVID-19 Antigen MIA has a sensitivity of 94% and a specificity of 100%, with time to results within 10 minutes. DiaTrust COVID-19 IgG/IgM Rapid Test has also shown a reliable performance with 96% positive percent agreement and 98.67% negative percent agreement for IgM, 92% positive percent agreement and 100% negative percent agreement for IgG. The test has a turnaround time of 15 minutes.
“Celltrion has been striving to bring the tests into the US. The need for more accessible, affordable, and most importantly, rapid diagnostic testing will grow, as the daily activities are coming back, and the economy is opening up again,” a Celltrion representative stated. “With the short turnaround time and promising performance of the sensitivity and specificity results, Celltrion is confident that both SAMPINUTE COVID-19 Antigen MIA and DiaTrust COVID-19 IgG/IgM Rapid Test will add great value to healthcare providers in screening patients and keeping communities safe.”
Related Links:
Celltrion Group
Gold Member
COVID-19 TEST READER
COVID-19-CHECK-1 EASY READER+
New
Piezoelectric Micropump
Disc Pump
New
HIV-1 Test
HIV-1 Real Time RT-PCR Kit
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants
Channels
Clinical Chemistry
view channel
Carbon Nanotubes Help Build Highly Accurate Sensors for Continuous Health Monitoring
Current sensors can measure various health indicators, such as blood glucose levels, in the body. However, there is a need to develop more accurate and sensitive sensor materials that can detect lower... Read more
Paper-Based Device Boosts HIV Test Accuracy from Dried Blood Samples
In regions where access to clinics for routine blood tests presents financial and logistical obstacles, HIV patients are increasingly able to collect and send a drop of blood using paper-based devices... Read more
Molecular Diagnostics
view channel
Simple DNA PCR-Based Lab Test to Enable Personalized Treatment of Bacterial Vaginosis
Approximately one in three women aged 14-49 in the United States will experience bacterial vaginosis (BV), a vaginal bacterial imbalance, at some point in their lives. Around 50% of BV cases do not present... Read more
Rapid Diagnostic Test to Halt Mother-To-Child Hepatitis B Transmission
Hepatitis B, an inflammation of the liver caused by the hepatitis B virus (HBV), is the second-leading infectious cause of death globally, following tuberculosis. This viral infection can result in serious... Read more
Hematology
view channel
New Scoring System Predicts Risk of Developing Cancer from Common Blood Disorder
Clonal cytopenia of undetermined significance (CCUS) is a blood disorder commonly found in older adults, characterized by mutations in blood cells and a low blood count, but without any obvious cause or... Read more
Non-Invasive Prenatal Test for Fetal RhD Status Demonstrates 100% Accuracy
In the United States, approximately 15% of pregnant individuals are RhD-negative. However, in about 40% of these cases, the fetus is also RhD-negative, making the administration of RhoGAM unnecessary.... Read more
Immunology
view channel
Post-Treatment Blood Test Could Inform Future Cancer Therapy Decisions
In the ongoing advancement of personalized medicine, a new study has provided evidence supporting the use of a tool that detects cancer-derived molecules in the blood of lung cancer patients years after... Read more
Cerebrospinal Fluid Test Predicts Dangerous Side Effect of Cancer Treatment
In recent years, cancer immunotherapy has emerged as a promising approach where the patient's immune system is harnessed to fight cancer. One form of immunotherapy, called CAR-T-cell therapy, involves... Read more
New Test Measures Preterm Infant Immunity Using Only Two Drops of Blood
Preterm infants are particularly vulnerable due to their organs still undergoing development, which can lead to difficulties in breathing, eating, and regulating body temperature. This is especially true... Read more
Simple Blood Test Could Help Choose Better Treatments for Patients with Recurrent Endometrial Cancer
Endometrial cancer, which develops in the lining of the uterus, is the most prevalent gynecologic cancer in the United States, affecting over 66,000 women annually. Projections indicate that in 2025, around... Read moreMicrobiology
view channel
Breakthrough Diagnostic Technology Identifies Bacterial Infections with Almost 100% Accuracy within Three Hours
Rapid and precise identification of pathogenic microbes in patient samples is essential for the effective treatment of acute infectious diseases, such as sepsis. The fluorescence in situ hybridization... Read more
Innovative ID/AST System to Help Diagnose Infectious Diseases and Combat AMR
Each year, 11 million people across the world die of sepsis out of which 1.3 million deaths are due to antibiotic-resistant bacteria. The burden of antimicrobial resistance (AMR) continues to weigh heavily,... Read more
Gastrointestinal Panel Delivers Rapid Detection of Five Common Bacterial Pathogens for Outpatient Use
Acute infectious gastroenteritis results in approximately 179 million cases each year in the United States, leading to a significant number of outpatient visits and hospitalizations. To address this, a... Read more
Pathology
view channel
New AI Model Predicts Gene Variants’ Effects on Specific Diseases
In recent years, artificial intelligence (AI) has greatly enhanced our ability to identify a vast number of genetic variants in increasingly larger populations. However, up to half of these variants are... Read more
Powerful AI Tool Diagnoses Coeliac Disease from Biopsy Images with Over 97% Accuracy
Coeliac disease is an autoimmune disorder triggered by the consumption of gluten, causing symptoms such as stomach cramps, diarrhea, skin rashes, weight loss, fatigue, and anemia. Due to the wide variation... Read more
Technology
view channel
Smartphones Could Diagnose Diseases Using Infrared Scans
Rapid advancements in technology may soon make it possible for individuals to bypass invasive medical procedures by simply uploading a screenshot of their lab results from their phone directly to their doctor.... Read more
Novel Sensor Technology to Enable Early Diagnoses of Metabolic and Cardiovascular Disorders
Metabolites are critical compounds that fuel life's essential functions, playing a key role in producing energy, regulating cellular activities, and maintaining the balance of bodily systems.... Read more
3D Printing Breakthrough Enables Large Scale Development of Tiny Microfluidic Devices
Microfluidic devices are diagnostic systems capable of analyzing small volumes of materials with precision and speed. These devices are used in a variety of applications, including cancer cell analysis,... Read more
Industry
view channel
Philips and Ibex Expand Partnership to Enhance AI-Enabled Pathology Workflows
Royal Philips (Amsterdam, The Netherlands) has expanded its partnership with Ibex Medical Analytics (Tel Aviv, Israel) and released the new Philips IntelliSite Pathology Solution (PIPS) to further accelerate... Read more
Grifols and Inpeco Partner to Deliver Transfusion Medicine ‘Lab of The Future’
Grifols (Barcelona, Spain), a manufacturer of plasma-derived medicines and innovative diagnostic solutions, has entered into a strategic agreement with Inpeco (Novazzano, Switzerland), a global leader... Read more
