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Rapid Tests
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SARS-CoV-2 Pooling Test
Vivalytic SARS-CoV-2 Pooling Test

The Vivalytic SARS-CoV-2 Pooling (COVID-19) is a rapid real time PCR test cartridge, providing clear and concise results in a timely manner, direct at the point of care to enable the patient to take the recommended safety precautions without delay. The new SARS-CoV-2 pooling test will allow users to test up to 160 samples a day and has sensitivity of 98% and a specificity of 100% – a world’s first. Highly sensitive assays allow for laboratories to accurately detect low positive samples, enabling for effective identification of positive COVID-19 cases in a timely manner.
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D-Dimer Test Kit (Immunofluorescence Assay)
D-Dimer Fast Test Kit (Immunofluorescence Assay)

D-Dimer Fast Test Kit (Immunofluorescence Assay) is intended for the in vitro quantitative determination of D-Dimer in human plasma or whole blood samples. The test is used as an aid in the assessment and evaluation of patients suspected of deep-vein thrombosis or pulmonary embolism.
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COVID-19 Ag Self Test
OnSite COVID-19 Ag Self Test

The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. The test is designed for use with self-collected samples within the first 7 days post-onset of symptoms, as an aid in identifying SARS-CoV-2 infection.
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Lactate Dehydrogenase (LDH) Assay

DiaSys LDH 21 FS is a new assay to determine lactate dehydrogenase (LDH), using a modified IFCC method that offers optimized performance. The ready-to-use reagent shows excellent calibration and onboard stability, as well as a wide measuring range and high precision.
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COVID-19 IgG-IgM Test
NG•TEST IgG-IgM COVID-19 All-in-One

The NG•TEST IgG-IgM COVID-19 All-in-One is an easy-to-use serological test for the qualitative detection of anti-SARS-CoV-2 antibodies (IgG and IgM).
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SARS-CoV-2 IgG Immunoassay
SARS-CoV-2 IgG II Quant

The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Alinity and ARCHITECT i Systems. The assay is to be used as an aid in the diagnosis of SARS-CoV-2 infection in conjunction with clinical presentation and other laboratory tests. The assay is also to be used as an aid in evaluating immune status of infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine, by quantitatively measuring IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2.
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SARS-COV-2 PLUS UK Real Time PCR kit

The SARS-COV-2 PLUS UK Real Time PCR kit is intended for the detection of nucleic acid from SARS-CoV‐2 in human respiratory samples and identification of the SARS-CoV‐2 variant from lineage B.1.1.7
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SARS-CoV-2 Test
Accula SARS-CoV-2 Test

The Accula SARS-CoV-2 Test performed on the Accula Dock or the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The test uses a nasal or nasal mid-turbinate swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
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SARS-CoV-2 Variants Assay
Allplex SARS-CoV-2 Variants II Assay

The Allplex SARS-CoV-2 Variants II Assay is intended for the simultaneous detection of four mutation sites in S gene for identification of SARS-CoV-2 variants. The multiplex real-time PCR assay detects and identifies four notable SARS-CoV-2 S gene mutations (L452R, W152C, K417T, and K417N) in a single tube.
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SARS-CoV-2 RT-PCR Assays
GSD NovaType Select SARS-CoV-2 Assay Family

GSD NovaType Select is a group of RT-PCR assays to discriminate variants of the SARS-CoV-2 virus. The assay family provides the opportunity to assemble a customized RT-PCR assay mutation panel from a basis kit including the enzyme mastermix, and a range of mutation specific sets, including primer, probes and controls. The research use only (RUO) Select assays detect the following mutations: K417N, K417T, L452R, T478K, E484K, P681R and P618H.
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Automated Procalcitonin (PCT) Test
Lumipulse G B•R•A•H•M•S PCT

Lumipulse G B•R•A•H•M•S PCT immunoreaction cartridges are for in vitro diagnostic (IVD) use with a two-step sandwich immunoassay method on the LUMIPULSE G system for the quantitative determination of procalcitonin (PCT) in human serum and plasma. The CE marked test is the most sensitive fully automated PCT test and the assay utilizes proven CLEIA (chemiluminescent enzyme immunoassay) technology with results that in up to 35 minutes.
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COVID-19 Real Time RT-PCR Kit
respiraScreen 1

The respiraScreen 1 real time RT-PCR Kit is a screening assay for the simultaneous detection of three groups of different respiratory viruses. The design allows the differentiation of Influenza Virus (Flu A, Flu B) and Respiratory Syncytial Virus (RSV A, RSV B) from the pandemic coronavirus SARS-CoV-2, extracted from biological specimens. The kit contains specific primers and dual-labeled probes for the amplification of RNA (cDNA) of Influenza A (M gene), Influenza B (NEP gene), RSV A (G gene), RSV B (G gene) and SARS-CoV-2 (E gene) extracted from biological specimen. Furthermore, the kit contains a Control RNA (Internal Process Control, IPC), which is added during RNA extraction and detected in the same reaction by a HEX-labelled probe. The Control RNA allows the detection of RT-PCR inhibition and acts as control that the nucleic acid was isolated from the biological specimen.
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SARS-CoV-2 S-RBD IgG Serology Test

MAGLUMI SARS-CoV-2 S-RBD IgG is a fully automated quantitative serology test to detect IgG antibodies against S-RBD (the receptor-binding domain of S protein). S-RBD binding antibodies have a strong correlation to the level of neutralizing antibodies, indicating its medical value of measuring immunity in natural infection and vaccination. The CE mark test has 99.6% specificity and 100% sensitivity at 15 days post-onset of symptom for COVID-19, which can provide more accurate and reasonable results within 30 minutes with ONLY 10uL sample volume. The test can be run on a global installed base of 16,000 MAGLUMI CLIA systems, including MAGLUMI X8 immunoassay analyzer, which can run up to 14,400 tests per day. Multiple MAGLUMI X8 could be connected to form a modular system to meet the high demands of large hospitals, especially during the COVID-19 pandemic period.
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Chromogenic Medium

CHROMagar mSuperCARBA is a highly sensitive chromogenic medium for the detection of a large variety of carbapene¬mases such as KPC, NDM, VIM, IMP, OXA. The CE Marked medium has an impressive limit of detection (10 CFU/mL) even for weakly expressed carbapenemases like OXA-48, while maintaining a high level of selectivity.
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SARS-CoV-2 qRT-PCR IVD Reagent Kit

The Agilent SARS-CoV-2 qRT-PCR Dx kit is a real-time reverse transcriptase PCR (qRT-PCR) in vitro diagnostic reagent kit for the qualitative detection of SARS-CoV-2 RNA. The CE-IVD marked kit contains a primer and probe mix that targets the N1 and N2 regions of the SARS-CoV-2 nucleocapsid gene and human RNase P, and includes a synthetic SARS-CoV-2 RNA positive control. RNA is isolated and purified from nasopharyngeal, nasal, and oropharyngeal swab specimens obtained from individuals suspected of having COVID-19 by their healthcare provider. The kit is validated for use with multiple automated RNA extraction systems and real-time PCR instruments and allows clinical laboratories to easily generate diagnostic results from this single-tube assay. • The Agilent SARS-CoV-2 qRT-PCR Dx kit is CE-IVD marked in accordance with the European Union In Vitro Diagnostic Directive 98/79/EC. • For In Vitro Diagnostic Use
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