Ezple Respiratory Pathogens Real-time PCR Kit is an in vitro diagnostic test for the qualitative detection of 19 respiratory viruses and 6 types of pneumonia-causing bacteria through nucleic acids isolated and extracted from human throat swabs using real-time polymerase chain reaction.
Ezplex Respiratory Pathogens Real-time PCR Kit is an in vitro diagnostic test for the qualitative detection of 19 respiratory viruses and 6 types of pneumonia-causing bacteria through nucleic acids isolated and extracted from human throat swabs using real-time polymerase chain reaction Comprehensive Panel- One test can identify 19 respiratory viruses and 6 bacterial species simultaneously. Sensitivity Detection of all targeted viruses and bacteria with high sensitivity. Convenience Genetree Viewer analysis software available for users to conveniently produce test results. Clinical Performance: Clinical testing confirmed the high sensitivity and specificity. Stability: Shelf life of up to 12 months. Analytical Specificity: Testing of 31 species of microorganisms showed no cross reactivity.
Antigen tests are used in the diagnosis of respiratory pathogens and are immunoassays that detect the presence of a specific viral antigen, which implies current viral infection. COVID-19 Antigen Rapid Test is designed to detect the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from the respiratory tract of a person and is gives results in a few minutes whether someone is infectious. Approved by clinical specimens and authorities, this product is intended exclusively for professional use in the laboratory and at the point-of-care. .
Product Description GeneTransport Medium Set - SG Medical Price of product ( USD price or FOB price) : USD2.4/set FOB Korea Product origin : REPURBLIC OF KOREA HS code 3821.00.0000 Key Specifications/Special Features : * For use in collecting, transporting and preserving salvia, oropharyngeal and nasopharynegeal specimens for the testing of respiratory pathogen * Increased testing accuracy: ^ Safe transport of samples by inactivation microbes and viruses ^ Visual checking of contamination using the indicator ^ 2 brushes for nasal and salvia samples * Stability of human body ^ Reduction of exposure to hazadous substances by using harmless water-based adhesive to attach brushess * Increased convenience ^ Automatic removal of brushes when the stopper is opened after transpoer * Storage method: unopened. At 18~25 deg.C for 12months after manufacturing Minimum Order Size and Packaging details : MOQ: 5000 sets
gg/igm double antibody is 15 minutes out of the accuracy of more than 90% or even up to 98%COVID 19 diagnostic kit is used for the qualitative detection of new coronavirus (2019-nCoV) antibodies in human whole blood, serum and plasma. Coronavirus (CoV) belongs to the order Nestivirus, Coronaviridae, and divided into three genera: �±, �², and �³. The alpha and beta gene are only pathogenic to mammals. The gamma gene mainly causes bird infections. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route. There have been seven types of human coronavirus (HCoCoV and 2019-nCoV), which are important pathogens of human respiratory tract infection.Among them, the new coronavirus (2019-nCoV) was found for 2019 cases of viral pneumonia in Wuhan. The clinical manifestations are systemic symptoms such as fever, fatigue, dry cough, dyspnea, which can quickly develop into severe pneumonia, respiratory failure, acute Respiratory distress syndrome, toxic shock, multiple organ failure, severe acid-base metabolism disorders and even life-threatening. 2019-nCoV Antibody Diagnostic Kit uses the principle of immunochromatographic method to qualitative detect the coronavirus (2019-nCoV) antibody in human whole blood, serum and plasma. It is used for clinical diagnosis of primary infection or secondary infection of new type of coronavirus infection pneumonia.
Sample Types : Including Nasopharyngeal swab, Oropharyngeal swab, Sputum Controls : Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results Product Information Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate. Authorized Laboratories Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests. About Emergency Use Authorization (EUA) This test (1) has not been FDA cleared or approved, (2) has been authorized by FDA under an EUA for use by authorized laboratories, (3) has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
INTENDED USE For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection. FEATURES Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2. Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva. Easy to use, easy results interpretation by naked eyes. Test result available within 15minutes. TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit. RESULTS INTERPRETATION Positive: A red line appears on the test line (T) and the control line (C). NOTE: A positive result does not rule out co-infections with other pathogens. Negative: Only the control line (C) appears, and no red line appears on the test line (T). NOTE: A negative result does not exclude infection. Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again. CLINICAL PERFORMANCE SARS-CoV-2 Antigen Test Kit Comparator Method (NTA) Positive Negative Total Positive 97 0 97 Negative 3 100 103 Total 100 100 200 - Positive Agreement (95% CI): 97/100 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100 100.0% (95.5% - 100%) - LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen. - Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable. - No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track. - Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%). [Product Name]: SARS-CoV-2 Antigen Test [Product Code]: Cat# FP-318 [Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva [Detection Method]: Colloidal Gold [Reaction Time]: Within 15min [Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1. [Storage Conditions]: 2*C ~ 30*C [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/99/2021.
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.