Cytomegalovirus(CMV) IgG/IgM Rapid Test

Cytomegalovirus(CMV) IgG/IgM Rapid Test
 
SPECIMEN: Whole Blood/ Serum/ Plasma
 
INTENDED USE
The One Step CMV IgG/IgM Rapid Test Device is a rapid qualitative lateral flow test designed for the quantitive detection of IgG and IgM antibodies to Cytomegalovirus (CMV) in human Whole blood, serum or plasma samples.
 
INTRODUCTION
Cytomegalovirus is a herpes virus and a leading biological factor causing congenital abnormalities and complications among those who receive massive blood transfusions and immunosuppressive therapy. About half of the number of pregnant women who contract a primary infection, spread the disease to their fetus. When acquired in-utero, the infection may cause mental retardation, blindness, and/or deafness. Serological tests for detecting the presence of antibody to CMV can provide valuable information regarding the history of previous infection, diagnosis or active or recent infection, as well as in screening blood for transfusions in newborns and immuno-compromised recipients.
 
PRINCIPLE
The One Step CMV IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to CMV in Whole blood, Serum or Plasma. Each test consists of: 1) a burgundy colored conjugate pad containing CMV recombinant envelope antigens conjugated with Colloid gold (CMV 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-CMV, T2 band is coated with antibody for the detection of IgG anti-CMV, 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-CMV, if present in the specimen, will bind to the CMV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a CMV IgG positive test result and suggesting a recent or repeat infection. IgM anti-CMV if present in the specimen will bind to the CMV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a CMV 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.
 
KIT COMPONENTS

MATERIALS REQUIRED BUT NOT PROVIDED

 
PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens and kits are handled.
• Handle all specimens as if they contain infectious agents.
• Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Follow standard biosafety guidelines for handling and disposal of potential infective material.
• Humidity and temperature can adversely affect results.

 
STORAGE AND STABILITY

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

 
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
 
Our mission:
 

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.