CMV Brite™

CMV and Infection:
Infection with CMV is common and, in the healthy human, is usually subclinical. However, CMV infection in the immunocompromised host (e.g. transplant recipients, HIV infected persons, AIDS patients, and the developing fetus) may result in either localized or disseminated disease. Clinical manifestations of CMV disease include pneumonia, retinitis, hepatitis, enteritis, and neurologic disease. Despite improved treatment modalities, CMV infection may result in significant morbidity and mortality in transplant patients, AIDS patients and cancer patients, particularly those with leukemia or lymphoma. Patients are at risk from both primary CMV infection and reactivation of latent infection..

Diagnosis of CMV infection:
Early and rapid diagnosis of CMV infection is of great importance in avoiding over-treatment with immunosuppressive drugs and in guiding antiviral therapy. Infection with CMV can be detected using different kinds of techniques, each with specific characteristics, advantages and disadvantages.

CMV infection can be diagnosed by:

  • Detection of CMV virus, i.e. CMV viremia, in which CMV is isolated from blood specimens.
  • Conventional CMV culture from blood or urine specimens.
  • Shell vial cultures.

These three methods give a delay in diagnosis of days to weeks, which is a major draw back for adequate treatment.

In addition other methods for CMV detection can be used:

  • Detection of CMV-IgM and CMV-IgG (serology)
  • More recently developed methods make use of detection of CMV DNA or RNA using PCR.

In contrast to the methods mentioned above, detection of CMV antigenemia using the CMV Brite™ kit is an excellent method for detection of an active CMV infection. It is also a rapid and reliable method for monitoring the course of cmv infection both during onset and regression. Reliable results can be obtained in 4 - 5 hours.

CMV Brite™ kit for in vitro diagnostic use:
The CMV antigenemia assay is a non-culture technique and has been proven to be a valuable method for detection of an active CMV infection by analysis of human blood samples. The antigenemia technique has been optimized and developed for use in the CMV Brite™ kit. been combined in the CMV Brite™ kit. The kit is available as a 40 test and a 100 test kit. The 40 test kit has been composed for analysis of single patient samples per experiment, while in the 100 test kit more patient samples can be analyzed in parallel per experiment.

Features of the CMV Brite™ Kit:

  • A complete kit (from drawing of a blood sample to fluorescence microscope reading
  • A rapid assay (completion within 5 hours)
  • A cocktail of antibodies of well-referenced antibodies, (C10/C11 antibodies)
  • Highly specific detection by indirect immunofluorescence
  • Unique composition of positive and negative control slides
  • Storage at + 2 to + 8 °C, no freezing needed
  • For in vitro diagnostic use: registered with the FDA (USA) and the Paul Ehrlich Institute (Germany

Clinical Impact of the CMV Brite™ kit:
The CMV Brite™ kit is the first immunofluorescence assay-based CMV antigenemia test kit which was registered with the American Food & Drug Administration (FDA) in 1996 for in vitro diagnostic use. In 1997, the CMV Brite™ kit has been registered with the Paul Ehrlich Institute in Germany as well. The kit has been demonstrated to be highly suitable for routine diagnostic use in monitoring active CMV infection in at least three major groups of patients:

  • Bone marrow transplant recipients
  • Solid organ transplant patients
  • HIV infected persons and AIDS patients

Using the CMV antigenemia assay detection of active CMV can be performed with two objectives. Firstly, as diagnostic parameter in the detection of an early stage active CMV infection, and secondly in monitoring of CMV infection during therapy.

Comparing CMV Brite™ to other methods:
The CMV Brite™ kit has been evaluated at two different clinical sites and was compared to CMV virus detection in conventional culture (CC) and shell vial culture (SV) using human peripheral blood leukocytes.

Based on the results of the clinical evaluation, an overall sensitivity of the CMV Brite™ kit was found of 90.8% and a very high specificity of 98.5%. The CMV Brite™ kit yielded a positive predictive value for active CMV infection of 96.7%, and a negative predictive value, i.e. no CMV infection, of 95.7%.

This evaluation demonstrated the excellent performance of the CMV Brite™ kit, when used with samples from bone marrow transplant recipients, organ transplant patients, and HIV-infected persons and AIDS patients.

Material and reagents supplied in the CMV Brite™ kit:
Reagent Description Volume
A: Dextran Solution 1 vial containing 100 ml (ready to use)
B: Erythrocyte Lysing Solution 1 vial containing 30 ml (dilute before use)
C: Fixative Solution 1 vial containing 290 ml (dilute before use)
D: Permeabilization Solution 1 vial containing 290 ml (dilute before use)
E: Fetal Calf Serum 1 vial containing 15 ml (dilute before use)
F: Mouse Monoclonal Antibody C10/C11 directed
against CMV lower matrix protein pp65		 1 vial containing 5.9ml (ready to use)
G: FITC-conjugated Sheep Anti-Mouse
Immunoglobulins with Evans Blue		 1 vial containing 5.9 ml (ready to use)
Control Slides: CMV Antigenemia Control Microscope Slides 20 slides (ready to use)




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