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CMV IgG/IgM Rapid Test WB/S/P
SPECIMEN: Whole Blood/ Serum/ Plasma
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.
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.
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.
Individually packed test devices
Each device contains a strip of CMV with colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
For adding specimens use.
Phosphate buffered saline and preservative.
For operation instruction.
MATERIALS REQUIRED BUT NOT PROVIDED
Specimen collection container
For specimens collection use.
For timing use.
For preparation of clear specimens
· 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.
SPECIMEN COLLECTION AND STORAGE
· The One Step CMV IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is intended only for use with human whole blood, serum or plasma specimens.
· Only clear, non-hemolyzed specimens are recommended for use with this test. To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
· Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20℃. Whole blood should be stored at 2-8℃ if the test is to be run within 2 days of collection. Do not freeze whole blood specimens.
· 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.
· Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
Contact: Rebecca Yan
Contact Person: Ms. Anna Lee