Sars CoV 2 IgM IgG检测试剂盒胶体金免疫色谱
The AccuRapidTM SARS-CoV-2 IgM/ IgG Test assay is intended for the qualitative detection of SARS-CoV-2 virus IgM and IgG antibodies in human blood collected from individuals meeting CDC SARS-CoV-2 virus clinical criteria (e.g., a history of clinical signs and symptoms associated with SARS-CoV-2 virus infection) and/or CDC SARS-CoV-2 virus epidemiological criteria (e.g., history of residence in or travel to a eographic region with active SARS-CoV-2 transmission at the time of travel, or other epidemiological criteria for which SARS-CoV-2 virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas should be collectedbetween 8 days and 10 weeks after onset of symptoms or risk of exposure, respectively. The assay is intended for use in laboratories consistent with the latest CDC testing algorithms for the diagnosis of SARS-CoV-2 virus infection.
Assay results are for the presumptive detection of IgM and IgG antibodies to SARS-CoV-2 virus. Reactive results are not definitive for the diagnosis of SARS-CoV-2 virus infection. False positive results are possible in patients with a history of infection with other coronavirus. Confirmation of the presence of anti-SARS-CoV-2 IgM and/or IgG
antibodies in presumptive positive specimens requires additional testing according to the latest CDC testing algorithms for the diagnosis of SARS-CoV-2 virus infection. Laboratories are required to report presumptive positive results to the appropriate public health authorities.
Results of this test cannot be used as the sole basis of patient management decisions and must be combined with clinical observations, patient history, epidemiological information, and other laboratory evidences. SARS-CoV-2 IgM/IgG levels over the course of illness are not well characterized. IgM/ IgG levels are variable, may be detectable near day three post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results do not preclude the possibility of SARS-CoV-2 virus infection, past or present. Negative results may
be usually seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM/IgG closes.
The AccuRapidTM SARS-CoV-2 IgM/ IgG assay is intended for use by trained laboratory personnel who are proficient in performing and interpreting immunoassays.
SUMMARY Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a new coronavirus, that aroused the outbreak of infections in Wuhan in 2019 . Similar to other coronavirus, SARS-CoV-2 virus is a membrane-enveloped virus with single-stranded, positive sense RNA genome.
Most people infected with SARS-CoV-2 virus do not have symptoms, but when resent they are usually mild and last less than seven days. The most common symptoms of a SARS-CoV-2 infection are fever, headache, nausea and vomiting. The most haracteristic symptom of COVID-19 patients is respiratory distress.
During the first 14 days after onset of symptoms, SARS-CoV-2 virus disease can be diagnosed by performing reverse transcriptase-polymerase chain reaction (RT-PCR) in samples of symptomatic patients. Virus-specific IgM and IgG antibodies are typically present after the first four days of illness and may be detectable, for up to 12 weeks. Combined with patient demography and clinical findings, detection of IgM and IgG antibodies to SARS-CoV-2 virus provides an essential tool for diagnosing and following up an acute or recent infection. There is currently no available vaccine or
anti-viral drug treatment for SARS-CoV-2 virus.
The method for detection of specific IgM and IgG antibodies to SARS-CoV-2 virus is an antibody capture colloidal gold Chromatography.
A recombinant SARS-CoV-2 virus Np antigen is labled to the colloidal gold anoparticles. IgM and or IgG antibodies present in patient blood bind to the antigen conjugate with gold nanoparticles , then chromotograph to the test line,which is coating with monoclonal antibodies directed against human IgM and IgG.
• For In Vitro Diagnostic Use under Emergency Use Authorization only.
• Use of this product is limited to specified laboratories and clinical laboratory personnel who have been trained in the techniques of serology and in vitro diagnostic procedures on authorized instruments.
• Laboratory biosafety guidance for working with SARS-CoV-2 virus specimens is provided at http://www.cdc.gov/. Itis recom can be safely worked with in a biosafety level 2 (BSL-2) laboratory.
• FOR IN VITRO DIAGNOSTIC USE – Not for internal or external use in humans or animals.
• All specimens, biological reagents and materials used in the assay must be considered potentially able to transmit
infectious agents. Avoid contact with skin, eyes or mucous membranes. Follow good industrial hygiene practices during testing.
• Do not eat, drink, smoke or apply cosmetics in the assay laboratory.
• Do not pipette solutions by mouth.
• Avoid direct contact with all potentially infectious materials by wearing lab coat, protective eye/face wear and disposable gloves.
• Wash hands thoroughly at the end of each assay.
• Avoid splashing or forming aerosols when handling, diluting or transferring specimens or reagents. Any reagent spill should be decontaminated with 10% bleach solution (containing 0.5% sodium hypochlorite) and disposed of as though potentially infectious.
• Waste materials should be disposed of in accordance with the prevailing regulations and guidelines of the agencies holding jurisdiction over the laboratory, and the regulations of each country.
• Do not use kits or components beyond the expiration date given on the label.
• Do not mix reagents from different kit lots.