Intended Use
The One Step HAV IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Hepatitis A Virus (HAV) in Whole Blood /Serum / Plasma to aid in the diagnosis of Hepatitis A Virus.
Summary
Hepatitis A is an acute, usually self-limiting disease of the liver caused by hepatitis A virus (HAV). HAV is transmitted from person to person, primarily by the faecal-oral route. The incidence of hepatitis A is closely related to socioeconomic development, and seroepidemiological studies show that prevalence of anti-HAV antibodies in the general population varies from 15% to close to 100% in different parts of the world. One step HAV IgG/IgM Test is a simple, visual qualitative test that detects Hepatitis A Virus antibodies in human Whole Blood /Serum / Plasma. The test is based on immunochromatography and can give a result within 15 minutes.
Principle
The One Step HAV IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of Hepatitis A Virus antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing HAV recombinant envelope antigens conjugated with Colloid gold (HAV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-HAV, T2 band is coated with antibody for the detection of IgG anti-HAV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-HAV, if present in the specimen, will bind to the HAV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a HAV IgG positive test result and suggesting a recent or repeat infection. IgM anti-HAV if present in the specimen will bind to the HAV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a HAV IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
Storage and Stability
Store as packaged in the sealed pouch at room temperature or refrigerated (4-30 or 40-86). The test device is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
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SARS-CoV-2 Rapid Antigen Test kit Colloidal Gold Method Medical Simple Rapid Convenient Sensitivity : 98.4% Specificity : 98.1% Test Time : 10-15min
Our COVID-19 rapid test kit can be used effectively on many levels for proper screening and strategic preparedness toward the pandemic. The test kit requires no sophisticated equipment nor laboratory settings. Our SARS-COV-2 Antibody Rapid Test Kit can be applied for screening of COVID-19 disease on the following: General practitioners and external clinics level to detect previous SARS-COV-2 viral infections on both symptomatic and asymptomatic patients. Determination of the immunity level of front-line healthcare workers, which can help in the development of pandemic preparedness strategies at national levels. Epidemiological COVID-19 surveys at national and district levels for research purposes. Airport screening for arriving /departing passengers to control the pandemic in the aviation industry. Suspected cases exclusion to minimize cost and time spent in the RT-PCR testing procedures. Screening on the national level to facilitate decision making regarding lockdown and curfew easing strategies. Phoenix Bioscience is offering a competitive price for a high-quality kit that is made in Canada and used currently to combat the pandemic in most American cities.
COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) The accuracy of the rapid test is 93% for IgM detection and 98% for IgG detection, compared to the RT-PCR Tests done at individual labs in The Netherlands. Pricing clears and depends on volumes naturally. Please ask the exact quote with the volume requested information. CE and FDA EUA approved Made in USA, Germany, Canada
In the past two months, China was infected by the COVID-19( Noval Coronavirus), in order to diagnose the diseases earlier, Encode team work hard and finally develop the COVID-19 IgM/IgG rapid test kit, which clinical positive detection rate is over 90%.
A rapid test for the qualitative detection of antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma. For professional in vitro diagnostic use only. INTENDED USE The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections. DIRECTIONS FOR USE Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 30°C) prior to testing. 1.Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible. 2.Place the test device on a clean and level surface. For Serum or Plasma Specimens: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 L) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S). For Whole Blood (Venipuncture/Fingerstick) Specimens: To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 uL) and start the timer. See illustration below. To use a micropipette: Pipet and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below. 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Till now we already exported 20 million tests and we can promise you very high quality. 25 tests/box, CE Mark and ISO, Clinical report, Certificate of analysis (COA) available Clinical specify >98.89% Accuracy: 93.41% Specimen: whole blood/serum, 10 minutes to get results
Rapid 2019-nCoV IgG/IgM Combo Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. Rapid 2019-nCoV IgG/IgM Combo Test Card is a supplement detection for COVID-19 suspected infected patients besides nucleic acid test, which could greatly raise the accuracy of the detection for COVID-19. 25 tests/box, CE Mark and ISO, Clinical report, Certificate of analysis (COA) Clinical specify >98.89% Accuracy: 93.41% Specimen: whole blood/serum, 10 minutes to get results
Hi need covid-19 igg/igm rapid tear cassette? Promise you very high quality, and till now we already export more than 20 million tests and our Europe client said our product this way: you are the brain the world
