3.000.000 of COVID-19 rapid tests available on stock in Romania; 1 to 2 days for delivery everywhere in Europe.
We are the European representative of the Korean manufacturer of covid-19 rapid detection kit
1. GENEDIA W COVID-19 Ag, nasopharyngeal differential detection of COVID-19;
2. GENEDIA W ONE COVID-19 IgM/IgG differential detection of COVID-19 IgM and IgG;
3. GENEDIA W COVID-19 Ag (SALIVA)
All the tests have CE mark, exceptional sensitivity and quality, can be used both by medical staff and for self-testing. All documentation is available upon request,
Coronavirus Ag Rapid Test Cassette (Swab)
have been placed on the European Market, based on the following performance characteristics (which are also included in the IFU included in each test kit)
Coronavirus Ag Rapid Test Cassette (Swab)
Method
Coronavirus Ag Rapid Test Cassette
Total Results
Relative Sensitivity: 86.7% Relative Specificity: 100% Accuracy: 96.3%
Coronavirus Ag Rapid Test Cassette (Swab)
The CE mark has been applied as the products fit the definition of an in vitro diagnostic medical device as defined in the IVD Directive and are classified as a general IVD products as they are not included in List A or List B, and they are not intended to be used by lay users.
Please note that this
702 Diagnostic Kits Suppliers
Short on time? Let Diagnostic Kits sellers contact you.
CoVirion-CV19-2 SARS-CoV-2 OneStep RT-PCR kit is a probe-based Real Time PCR test designed for the qualitative detection of SARS-CoV-2 Coronavirus, the etiological agent of COVID-2019. It is used to detect N-gene and S-gene in viral RNA.
Co-virion Rapid Antigen Test is an immunochromatographic test designed to qualitatively detect SARS-CoV- 2 antigen in nasopharyngeal geal swab specimens. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
Co-virion Rapid Antigen Test is an immunochromatographic test designed to detect the nucleocapsid protein of SARS-CoV-2 in nasopharyngeal swabs (NP). The test strip contains colloidal-gold conjugated particles with monoclonal antibodies against the nu- cleo- capsid protein of SARS-CoV-2. The capture antibodies for nucleocapsid protein of SARS-CoV-2 are coated on the nitrocellulose membrane. When the sample is applied to the sample window (S well), the conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 is present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific an- ti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T), which develops a red line in T region. Presence of T line indicates a positive result. There is also an internal control line to check the accuracy of the test performance. The control line is coated with goat anti-Rabbit IgG antibody which binds to the gold labeled antibody. Failure to form C line confirms the incorrect procedural technique.
Cov-inu RT-PCR kit is a probe based Real Time PCR test designed for the qualitative de- tection of SARS-CoV-2 Coronavirus, the etiological agent of COVID-2019 and A + B Group Inuenza virus (orthomyxovirus). It is used to detect S- M2 ve NS1 genes in viral RNA.
Description of the Kit
Cov-inu RT PCR Kit is a multiplex PCR kit that is used for the simultaneous detection of COVID-19 agent SARS-COV-2 and Inuenza A and Inuenza B viruses from the same sample. Coronaviruses are a large family of viruses that cause infections in humans and other mammals (such as camels, cats, dogs, and bats). The SARS-CoV-2 virus is a new coronavirus that was identified by the World Health Organization (WHO) (1) on February 11, 2020. Inuenza is caused by three types of immunological RNA viruses (A, B and C) in the Orthomyxoviridae family. Seasonal inuenza is typically caused by three main hem- agglutinin subtypes (H1, H2, and H3) and two neuraminidase subtypes (N1 and N2). It is important that public health laboratories around the world conduct detailed surveillance to monitor the spread and impact of the pandemic H1N1 2009 virus, as well as predict future changes in virulence (4). Therefore, methods for rapid diagnosis, case detection and follow-up of this new pathogen in the human population are necessary to develop appropriate management strategies to reduce morbidity and mortality. The test works with single-stage real time reverse transcriptase polymerase chain reaction (On- eStep RT-PCR) with serum, lower respiratory tract samples (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract samples (e.g. nasopharyngeal uids, nasal swab) from individuals who demonstrate clinical criteria set for COVID-19 by WHO (2) and CDC (Center for Disease Control and Prevention) (3). This kit is an In-vitro diagnostic kit using specific primers designed for qualitative detection of genomic RNAs of SARS-CoV-2, Inuenza A and Inuenza B virus.
Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation.
General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision.
Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals.
Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .
