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Quick test Antibodies Reopen, IgG/IgM, Covid 19, 1 pc, Montana MedINDICATIONS FOR USE The reOpenTest COVID-19 lgG, lgM Cassette Rapid Test is a rapid, lateral flow immunochromatographic test on a solid support for the rapid, qualitative, differential determination of lgG and lgM antibodies developed against SARS-CoV-2 in human venous whole blood (sodium heparin, EDTA and sodium citrate), serum or plasma (sodium heparin, EDTA and sodium citrate). Rapid Cassette Test ReOpenTest COVID-19 lgG, lgM is indicated for the identification of individuals with an adaptive immune response to SARS-CoV-2, indicating a previous or recent infection. It is currently not known precisely* how long antibodies persist after a SARS-CoV-2 infection, nor whether the presence of antibodies confers immunity. The reOpenTest COVID-19 lgG, lgM Rapid Cassette Test should not be used for the diagnosis of acute SARS-CoV-2 infection. The test result indicates the detection of antibodies to SARS-CoV-2. Specific IgG and IgM antibodies are generally detectable in the blood starting a few days after infection, even though the duration of antibody persistence is not sufficiently characterized. Individuals may have detectable viral antigens for several weeks after seroconversion. Depending on the regulations in force, laboratories may be required to report all positive tests to the competent authorities. The sensitivity of the Rapid reOpenTest COVID-19 lgG, lgM test immediately after infection is unknown. Negative results cannot exclude acute SARS-CoV-2 infection. In case of suspicion of acute infection with SARS-CoV-2, direct testing for the virus is necessary. False positive results of the Rapid reOpenTest COVID-19 lgG test are possible, lgM through the cross-reactivity of pre-existing antibodies or other possible causes. Due to this risk of false positive results, it is recommended to confirm positive results with another IgG, IgM test.Summary and explanations The new coronaviruses belong to the genus b. SARS-CoV-2, also known as the COVID-19 virus, causes a disease expressed as an acute respiratory infection. The population is generally susceptible. Currently, patients infected with the novel coronavirus represent the main source of contamination; asymptomatic patients can also transmit the infection. Based on recent epidemiological investigations, the incubation period is between 1 and 14 days, in most cases between 3 and 7 days. The main manifestations include fever, asthenia and dry cough. Nasal congestion, rhinorrhea, sore throat, myalgia and diarrhea are less common symptoms. The reOpenTest COVID19 Rapid Test is a rapid test that uses a combination of antigen-coated colored particles for the detection of IgG and IgM antibodies specific for SARS-CoV-2 in human whole blood, serum or plasma.TESTING PRINCIPLE The COVID-19 IgG/IgM Rapid Cassette Test (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic test for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The test uses anti-human IgM antibodies (IgM test strip), anti-human IgG antibodies (IgG test strip) and goat anti-murine IgG (control strip C) immobilized on a nitrocellulose strip. The conjugation bed contains recombinant SARSCoV-2 antigens (RBD domain of the “Spike” protein, the main antigen of SARS-CoV-2) conjugated to colloidal gold. During testing, the sample will bind to particles coated with the SARS-CoV-2 antigen-colloidal gold complex in the test cassette. When a sample, along with the test buffer, is placed in the sample well, the IgM and/or IgG antibodies (if present in the sample) will bind to the COVID-19 complex, forming an antibody-antigen complex. This antibody-antigen complex migrates along the nitrocellulose membrane by capillarity. When the complex reaches the band corresponding to the immobilized antibody (anti-human IgM or/and anti-human IgG antibodies), this complex is captured at the band level, forming a red-burgundy band that confirms a positive result. The absence of colored bands in the test region indicates a negative result. To serve as a procedural control, the control band in the control region will always turn from blue to red, indicating that an optimal volume of sample has been deposited in the sample well and that membrane soaking has been achieved.TEST KIT CONTENTS: 1 sealed blister pack; each blister contains one cassette test, 1 vial of extraction solution (buffer) 80µl; 1 pipette; 1 alcohol pad; 1 lancet; leaflet. MATERIALS REQUIRED FOR SAMPLE COLLECTION (not included in the test kit) 1. Stopwatch or smartphone for measuring time STORAGE AND STABILITY: The kit can be stored at room temperature or refrigerated (2-30oC). The test device is stable until the expiration date printed on the sealed blister. The test device should be kept in the sealed blister until use.DO NOT FREEZE ! Do not use the tests after the expiration date. WARNINGS AND PRECAUTIONS: 1. The test is intended for professional in vitro diagnostic use only. Do not use after the expiration date. 2. This test has only been authorized for the detection of the presence of IgM and IgG antibodies against SARS-CoV-2, not against other viruses and pathogens and 3. This test is authorized only during the existence of circumstances justifying authorization for the emergency use of in vitro diagnostic tests for the determination of COVID-19 under Section 564 (b)(1) of Act. 21 USC $ 360bbb-3(b)(1), if this authorization is not withdrawn or revoked sooner. 4. Read the entire package insert before testing. Failure to follow the instructions will result in inaccurate results. 5. Do not use tests whose packaging (blister) is damaged or broken. 6. Single-use test. Do not reuse tests. 7. Handle specimens in accordance with precautions for handling infectious agents. Verify that measures to prevent contamination with microbiological agents are applied throughout testing and that specimens are handled and disposed of appropriately after testing. 8. Wear appropriate protective equipment (gown/suit, disposable gloves and safety glasses. 9. Extreme humidity and temperature may affect test results. 10. Do not perform the test procedure in spaces with strong air currents (fans or under a strong air jet) SAMPLE COLLECTION: 1. The COVID-19 IgG/IgM Rapid Cassette Test can be performed using whole blood, plasma or serum. 2. Whole blood or plasma can be collected in tubes containing heparin or citrate Separate serum or plasma from blood as quickly as possible to avoid hemolysis. Use only clear, non-hemolyzed samples. 3. Testing should be performed as soon as possible after sample collection. Do not store samples at room temperature for an extended period of time. Serum and plasma samples can be stored at 2-8oC for up to 3 days. For storing samples for longer periods, temperatures below -20oC will be used. Whole blood collected by venipuncture can be stored for a maximum of 2 days before testing at 2-8oC after collection. Do not freeze whole blood samples. Whole blood collected by finger prick will be tested immediately. 4. Bring samples to room temperature before testing. Frozen samples should be thawed completely and mixed thoroughly before testing. Samples should not be frozen and thawed repeatedly. 5. The transport of samples is carried out in accordance with local procedures for the transport of etiological agents. TESTING PROCEDURE: Wait until the test cassette, specimen, and buffer liquid reach room temperature (15-30oC) before testing. 1. Remove the test cassette from the sealed blister and use it as soon as possible. The best results are obtained when testing is performed within one hour of unsealing. 2. Place the test device on a flat, clean surface. For Serum or Plasma Samples Collect the serum or plasma sample using the 10 µL plastic micropipette provided in the test kit. Extract serum or plasma until it exceeds the Sample Level Line as shown in the image below and then transfer the extracted serum or plasma to the corresponding sample well (S). Immediately add 2 drops (approx. 80 µL) of buffer solution to the same well corresponding to the sample (S). Avoid the formation of air bubbles. Wait until the colored indicator bands appear. The final result will bePresentation: 1 pc.
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Vânzător: Liki24.co.uk
Brand: Montana Med
