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登革热&寨卡病毒联检试剂盒

上架时间:2017-3-6 10:43:56      浏览次数:
  • 产品品牌:   
  • 产品货号:   B828C
  • 产品规格:   
  • 检测方法:   胶体金法
产品介绍

Dengue IgG/IgM Ab & Zika Virus IgG/IgM Ab Combo(Serum/Plasma/Whole Blood)

Catalog No: B828C
A rapid and sensitive test for the qualitative detection of IgG and IgM antibodies dengue virus and IgG & IgM Antibodies to Zika Virus in human serum, plasma, or whole blood. For professional in vitro diagnostic use only.
Intended Use
TELL ME FAST Dengue & Zika Combo test is a qualitative test for simultaneous detection of IgG and IgM antibodies to dengue virus and Zika Virus in human serum plasma or whole blood. The test provides a differential detection of anti-dengue IgG, IgM antibodies and ant IgG & IgM antibodies to Zika Virus and can be used for the presumptive distinction between a primary, secondary and an early dengue and zika infection. This test is for professional In-Vitro Diagnostic use only. This is a screening test and results should be confirmed with other qualifying assays.
Summary
Dengue virus, a virus belonging to the Flavavirus group of viruses, is one of the most significant mosquito-born diseases in the world in terms of morbidity and mortality. Transmitted principally by the mosquito types Aedes aegypti and Aedes albopictus, the virus is found commonly throughout the tropic and subtropic regions of the world. There are four known serotypes of dengue. Symptoms of dengue fever include high fever, headache, muscle pain and skin rash. The complications often associated with this infection are dengue hemorrhagic fever or dengue shock syndrome. The immune response to this virus includes the production of IgM antibodies by the 5th day of symptoms, which remain in the circulatory system for 30-60 days. IgG antibodies appear by the 14th day of infection and persist for life. A secondary infection often results in high fever and, in many cases, initiates hemorrhagic events and circulatory failure. A secondary infection also induces an IgM antibody response after 20 days of infection and IgG antibodies rise within 1-2 days after the onset of symptoms. Therefore, patients with secondary infections will have a positive IgG result, usually with a positive IgM result as well. Thus, the use of a reliable and sensitive rapid serological test that can simultaneously detect the presence of anti-dengue IgG and IgM antibodies is of great clinical utility. Biocan TELL ME FAST Dengue IgG/IgM rapid test provides an excellent methodology for specifically detecting anti-dengue IgG and IgM antibodies. The presence of high titers of IgG antibodies does not interfere with the detection of IgM antibodies in the sample. By using a mixture of highly purified dengue proteins, the test is able to detect all 4 Dengue serotypes.
Zika virus (ZIKV) is a mosquito-borne flavivirus that was first isolated from a rhesus monkey in the Zika forest of Uganda in 1947. In 1968, isolation from human hosts occurred in residents of Nigeria. Since then, multiple studies have confirmed ZIKV antibody in humans from a multitude of countries in Africa and parts of Asia. In 2015, ZIKV first appeared outside of Africa and Asia when it was isolated in Brazil where is has caused a minor outbreak following the 2014 FIFA World Cup. ZIKV is closely related to other mosquito-borne flaviviruses such as the dengue, yellow fever, West Nile, and Japanese encephalitis viruses. ZIKV causes a disease known as Zika fever, which is characterized by a macropapular rash covering the body, fever, joint pain, and malaise. Although there have yet to be serious complications arising from ZIKV, it's appearance across the globe, mosquito-driven transmission cycle, and possible spread via sexual contact make ZIKV an important emerging pathogen whose global impact is yet to be discovered. Diagnosis for ZIKV infection include PCR tests to detect viral DNA as well as additional tests to detect ZIKV antibody (IgM) in serum. IgM for ZIKV is typically detectable around 3-5 days after infection, but cross-reactivity with closely related dengue, yellow fever, Japanese encephalitis, and West Nile viruses are possible. Thesecross-reactive results were more common in patients that denoted signs of previous flavivirus infection than patients with primary ZIKV infection. For best diagnosis practices, serum samples should be analyzed as early as possible with a second test 2 to 3 weeks after that.
Principle
The TELL ME FAST Dengue IgG/IgM Ab Test (Serum/Plasma/Whole blood) is a qualitative test for the detection of IgG and IgM antibodies to denngue virus in human serum, plasma, or whole blood. The test provides a differential detection of anti-dengue IgG and anti-dengue-IgM antibodies and can be used for the presumptive distinction between a primary, secondary and early dengue infection. Serum, plasma, or Whole blood samples may be used with this test. In the Dengue IgG/IgM test first a specimen is dispensed with sample buffer, the Gold antigen conjugate will bind to anti-Dengue IgG and IgM antibodies in the specimen sample which in turn will bind with Anti-Human IgG and Anti-Human IgM coated on the membrane as three separate lines in the test region as the reagent move across the membrane. The anti-Human antibodies on the membrane will bind the IgG or IgM antigen complex at the relevant IgG and or IgM test lines causing pale or dark pink lines to form at the IgG or IgM region of the test membrane. The intensity of the lines will vary depending upon the amount of antibody present in the sample. The appearance of pink line in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM).
Biocan Tell Me Fast Zika Virus IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of a pink colored conjugate pad containing recombinant (Zika NS1 protein & envelope protein) common antigens conjugated with colloid gold and rabbit IgG-gold conjugates, a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T2 & T1 band is pre-coated with monoclonal anti-human IgM & IgG 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 cassette, the specimen migrates by capillary action across the cassette. Zika Virus IgM antibodies if present in the specimen will bind to the Zika conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored T1 band, indicating a Zika Virus IgM positive test result. Zika virus IgG antibodies if present in the specimen will bind to the Zika conjugates. Absence of any test 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 test bands. Otherwise, the test result is invalid and the specimen must be retested with another device. Since a single serum in the acute phase is presumptive, it is recommended that a second sample be taken 1–2 weeks after the first sample to demonstrate seroconversion (negative to positive) or an increase on the antibody titer. In primary infections (first infection with a flavivirus) it has been demonstrated that antibodies cross-reaction is minimal with other genetically related viruses. However, it has been demonstrated that sera of individuals with a previous history of infection from other flaviviruses (especially dengue, yellow fever and West Nile) can cross-react in these tests. Although neutralization by plaque reduction (PRNT) offers a greater specificity in the detection of neutralizing antibodies (IgG), cross-reactions have also been documented; in fact, some patients with a previous history of infection by other flaviviruses have shown up to a fourfold increase in neutralizing antibody titers when infected with ZIKV. It is highly recommended that suspected patients with Zika Virus infection be also tested for dengue and chikungunya
Reagents
The test cassette contains 2 strips which contains Dengue antigens coated particles and anti-Human IgG and anti-Human IgM coated on the membrane and Zika Chikungunya antigens coated particles and anti-Human IgG and anti-Human IgM coated on the membrane.
Precautions
1、 For professional in vitro diagnostic use only. Do not use after the expiration date.
2、The test should remain in the sealed pouch until use.
3、 All specimens should be considered potentially hazardous and handled in the same manner as infectious agents.
4、The test should be discarded in a proper biohazard container after testing.
5、Optimal assay performance requires strict adherence to the assay procedure described in this Instruction sheet and any deviations from the procedure may lead to aberrant results.
Storage & Stability
Store as packaged in the sealed pouch at 2 - 30°C and not in direct sunlight. The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Materials
Materials Provided:
1. Test Device with desiccant in individual pouch (15 tests per box)
2. Dengue Antibody Diluent Buffer (3mL/bottle)
3. Zika Diluent Buffer (3ml/bottle)
4. Instructions for Use
Materials Required but Not Provided:
1. Specimen collection container or other collection tubes
2. Timer
Specimen Collection & Preparation
1. Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.
2. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
4. If specimens are to be shipped, they should be packed in compliance with federal regulations for the transportation of etiologic agents.
Directions for Use
Allow the test device, specimen and/or buffer to equilibrate at room temperature (15-30°C) before testing.
1. Bring the pouch to room temperature before opening it. 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. Perform the below steps within 15 minutes of opening the pouch of the cassette.

FOR DENGUE IgG/IgM Ab

1. For serum, plasma or whole blood, pipette 10 μL into the sample well; then immediately add 2 drops of buffer into the sample well.

2. Wait for the red line(s) to appear. The test result should be read between 15 and 20 minutes.
Note: Do not interpret the result after 30 minutes.

FOR ZIKA IgG/IgM Ab

1. Pipette 25μL of serum, plasma or whole blood into the sample well.
2. Add 2 drops of diluent buffer to sample well.
3. Wait for the red line(s) to appear. The test result should be read between 15 and 20 minutes.
Note: Do not interpret the result after 30 minutes.

Interpretation of Results

Dengue IgG/IgM Ab
IgM POSITIVE: Two distinct red lines appear. The control line (C) and IgM line are visible on the test cassette. The test is positive for IgM antibodies. This is indicative of a primary dengue infection.
IgG POSITIVE: Two distinct red lines appear. The control line (C) and IgG line are visible on the test cassette. The test is positive for IgG antibodies. This is indicative of a secondary or past dengue infection.
IgM and IgG POSITIVE: Three distinct red lines appear. The control line (C), IgM and IgG lines are visible on the test cassette. The test is positive for IgM and IgG antibodies. This is indicative of a secondary dengue infection.
NEGATIVE: One distinct red line appears. The control line (C) is the only line visible on both the sides of the cassette. No IgG, IgM antibodies The result does not exclude dengue infection. A new sample should be drawn from the patient in 3-5 days and then should be retested.
INVALID: Control line fails to appear. The test results are INVALID, if no control line (C) is visible, regardless of the presence or absence of lines in the IgG or IgM region of the cassette. Repeat the test using a new cassette.
NOTE: The intensity of the red color in the test line regions IgG and IgM will vary depending on the concentration of IgG and IgM present in the specimen. However, neither the quantitative value nor the rate of increase in IgG or IgM can be determined by this qualitative test..
Zika IgG/IgM Ab
IgM POSITIVE: Two distinct red lines appear. The control line (C) and IgM (M) line are visible on the test cassette. The test is positive for anti- Zika Virus IgM antibodies
IgG POSITIVE: Two distinct red lines appear. The control line (C) and IgG (G) line are visible on the test cassette. The test is positive for anti-Zika Virus IgG antibodies.
IgM and IgG POSITIVE: Three distinct red lines appear. The control line (C), IgM (M) and IgG (G) lines are visible on the test cassette. The test is positive for anti-Zika Virus IgM and IgG antibodies.
NEGATIVE: One distinct red line appears. The control line (C) is the only line visible on the test cassette. No Zika Virus IgM antibodies were detected. The result does not exclude Zika Virus infection. A new sample should be drawn from the patient in 3-5 days and then should be retested.
Quality Control
A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is also required. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
Performance Characteristics
The overall sensitivity of Biocan Tell Me Fast Dengue IgG/IgM Antibody Test is 96.9% and specificity is 99.2%. The studies and clinical evaluations were conducted in correlation with Haemagglutination (HI)
Test, Elisa and other commercial rapid tests.
The overall sensitivity of Biocan Tell Me Fast Zika Virus IgG/IgM Antibody Rapid Test is still under examination and specificity is 99%. Currently we recommend the usage of this test for only preliminary presumptive screening purposes.
Cross Reactivity
In primary infections (first infection with a flavivirus) it has been demonstrated that antibodies cross-reaction is minimal with other genetically related viruses. However, it has been demonstrated that sera of individuals with a previous history of infection from other flaviviruses (especially dengue, yellow fever and West Nile) can cross-react in these tests, especially Zika. Although neutralization by plaque reduction (PRNT) offers a greater specificity in the detection of neutralizing antibodies (IgG), cross-reactions have also been documented; in fact, some patients with a previous history of infection by other flaviviruses have shown up to a fourfold increase in neutralizing antibody titers when infected with ZIKV. It is highly recommended that suspected patients with Zika Virus infection be also tested for dengue and chikungunya. Extensive testing has been performed on Biocan Zika IgG/igM Ab Test with Dengue and Chikungunya IgG & IgM positive samples from low to high titer and no cross reactivity has been observed.
Bibliography
1. Sabin, AB and Schlesinger RW. Production of immunity to Dengue with virus modified by propagation in mice: Science (1945), 101:640.
2. Lam, SK. Dengue haemorrhagic fever. Rev. Med. Micro. (1995), 6:39-48.
3. Innis, BL, Nisalak, A., et.al. An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am. J. Trap. Med. Hygiene (1989), 40:418-427.
4. CDC/NIH Guidelines. Biosafety in Microbiological and Biomedical Laboratories. 2nd Edition, 1988.
5. Siti-Strong. Diagnosis, prevention, and treatment of tropical disease, 7th ed., Philadelphia, the Ablakiston Company.
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7. Gourinat AC, O’Connor O, Calvez E, Goarant C, Dupont-Rouzeyrol M: Detection of Zika Virus in Urine. Emerging Infectious Diseases 2015, 21:84-6.
8. http://wwwnc.cdc.gov/eid/article/21/1/14-0894_article
9. Hayes EB: Zika virus outside Africa. Emerging Infectious Diseases 2009, 15:1347-50.
10. European Center for Disease Prevention and Control. Rapid Risk Assessment. Zika virus infection outbreak, French Polynesia. 2014.
11. http://ecdc.europa.eu/en/publications/Publications/Zika-virus-French-Polynesia-rapid-risk- assessment.pdf
12. Lanciotti RS, Kosoy OL, Laven JJ, Velez JO, Lambert AJ, Johnson AJ, et. al.: Genetic and Serologic Properties of Zika Virus Associated with an Epidemic, Yap State, Micronesia, 2007. Emerging Infectious Diseases 2008, 14:1232-6.
13. http://wwwnc.cdc.gov/eid/article/14/8/08-0287_article


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