Zika IgG/IgM Ab & Chikungunya IgG/IgM Ab Test
Intended Use: The BIOCAN TELL ME FAST Chikungunya IgG/IgM Combo Test Device (Serum/Plasma) is a qualitative test for the detection of IgG and IgM antibodies to Chikungunya virus in human serum, plasma or whole blood. The test provides a differential detection of anti-Chikungunya IgG and anti- Chikungunya-IgM antibodies and can be used for the presumptive distinction between a primary and secondary Chikungunya infection. This test is for In-Vitro Diagnostic use and for screening purposes only. All results should be verified with other qualified assays.
BIOCAN TELL ME FAST Zika Virus IgG/IgM Antibody Rapid Test is a qualitative lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Zika Virus in human serum, plasma or whole blood. This test can be used for the presumptive distinction between a primary and secondary Zika Virus infection. This test is for In-Vitro Diagnostic use only. All results should be verified with other qualified assays.
A mosquito-borne febrile disease, Chikungunya is characterized by mild to severe joint pain, muscle pain, headaches, nausea, and rashes. Most patients fully recover the effects of the joint pain are often debilitating and can last from days to months, or even years after initial infection. Clinical manifestations of Chikungunya maybe non-specific and is often mischaracterized as Dengue or other viral exanthema. Although, in most cases, the disease is not fatal, it has been known to cause fatalities due to respiratory failure and brain infections among a population where other diseases are present. The virus occurs in Africa, Asia and outbreaks have occurred on the islands of the Indian Ocean and localized outbreaks in Europe.
The BIOCAN TELL ME FAST Chikungunya IgG/IgM Combo Test Device is a qualitative test for the detection of IgG and IgM antibodies to Chikungunya virus in human serum, plasma or whole blood. The test provides a differential detection of anti-Chikungunya IgG and anti-Chikungunya IgM antibodies and can be used for the presumptive distinction between a primary and secondary Chikungunya infection. First a specimen is dispensed with sample buffer, the Gold antigen conjugate will bind to anti-Chikungunya IgG and IgM antibodies in the sample. In turn, this complex will bind with Anti-Human IgG and Anti-Human IgM coated on the membrane as two 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).
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. These cross-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.
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.