cmv-igm-04784618190-en-can
cmv-igm-04784618190-en-can
cmv-igm-04784618190-en-can
cobas e 411
04784618190 04784618500 100 cobas e 601
cobas e 602
English combination with a low avidity index for IgG is a strong indication of a recent
primary CMV infection.4,5,12 Seroconversion to CMV IgM and IgG may also
System information indicate a recent CMV infection.2,3,4,5,12
For cobas e 411 analyzer: test number 580
For cobas e 601 and cobas e 602 analyzers: Application Code Test principle
Number 011 µ-Capture test principle. Total duration of assay: 18 minutes.
Intended use ▪ 1st incubation: 10 µL of sample are automatically prediluted 1:20 with
Immunoassay for the in vitro qualitative determination of IgM antibodies to Diluent Universal. Biotinylated monoclonal anti‑h‑IgM‑specific antibodies
cytomegalovirus in human serum and plasma. are added.
Results obtained with this assay are used as an aid in the diagnosis of ▪ 2nd incubation: CMV‑specific recombinant antigen labeled with a
recent CMV infections. ruthenium complexa) and streptavidin-coated microparticles are added.
The electrochemiluminescence immunoassay “ECLIA” is intended for use Anti‑CMV IgM antibodies present in the sample react with the
on Elecsys and cobas e immunoassay analyzers. ruthenium-labeled CMV‑specific recombinant antigen. The complex
becomes bound to the solid phase via interaction of biotin and
streptavidin.
Summary ▪ The reaction mixture is aspirated into the measuring cell where the
microparticles are magnetically captured onto the surface of the
Cytomegalovirus (CMV), a member of the herpes virus family, is ubiquitous electrode. Unbound substances are then removed with
in all human populations, causing infections which are followed by life-long ProCell/ProCell M. Application of a voltage to the electrode then induces
latency in the host with occasional reactivations.1,2 The seroprevalence of chemiluminescent emission which is measured by a photomultiplier.
antibodies in adults ranges from 40‑100 % with inverse correlation to
socioeconomic status.1,2,3 CMV is transmitted through body fluids, including ▪ Results are determined automatically by the software by comparing the
blood, genital secretions and breast milk. Saliva and urine of infected electrochemiluminescence signal obtained from the reaction product of
individuals also represent a prominent source of infection, and children, the sample with the signal of the cutoff value previously obtained by
especially those attending day care facilities, are an important vector for calibration.
viral spread.2,3,4,5,6 In immunocompetent individuals primary CMV infection is a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
usually mild or asymptomatic.2,5 Patients commonly present with a Reagents - working solutions
mononucleosis-like syndrome, including fever, sore throat, cervical The reagent rackpack (M, R1, R2) is labeled as CMVIGM.
lymphadenopathy, malaise, headache, muscle ache and joint pains.2,3,5,7
During pregnancy, CMV can cause congenital infection which may result in M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:
permanent physical and/or neurological sequelae to the child.5 CMV
infection can be primary, i.e. newly acquired, or secondary, i.e. due to Streptavidin-coated microparticles 0.72 mg/mL; preservative.
reactivation of the latent virus or re-infection with a different viral strain.3,5
Primary CMV infection is reported in 1‑4 % of seronegative women during R1 Anti-h-IgM-Ab~biotin (gray cap), 1 bottle, 9 mL:
pregnancy and the risk of transmission to the fetus is estimated to be about Biotinylated monoclonal anti‑h‑IgM antibody (mouse) > 500 µg/L,
30‑40 %.3,4 Reactivation of CMV infection during pregnancy is reported in MES buffer 50 mmol/L, pH 6.5; preservative.
10‑30 % of seropositive women and, in this circumstance, the risk of
transmission of the virus is about 1‑3 %.3,4,5 Overall, prenatal CMV infection R2 CMV-Ag~Ru(bpy) (black cap), 1 bottle, 9 mL:
occurs in 0.6‑0.7 % of all life births in the developed world.4,5,8 The majority of
babies born with congenital CMV infection are asymptomatic at birth.8,9,10 Of CMV‑specific antigen (recombinant, E. coli) labeled with ruthenium
these 5‑15 % still develop irreversible impairments, most frequently hearing complex > 50 µg/L; MES buffer 50 mmol/L, pH 5.5; preservative.
loss, that can occur several months or even years after birth.5,8,9,10 For babies
symptomatic at birth, prognosis is very poor, and the vast majority will CMVIGM Cal1 Negative calibrator 1 (white cap), 2 bottles of 1.0 mL
develop severe mental impairment and/or hearing loss.5,8,9,10 Different studies each:
have shown that the risk of symptomatic congenital disease in the fetus or
newborn infant is high, when maternal primary infection takes place in early Human serum, negative for anti‑CMV IgM; preservative.
pregnancy before week 20 of gestation, and lower thereafter.4,5 The CMVIGM Cal2 Positive calibrator 2 (black cap), 2 bottles of 1.0 mL each:
congenital CMV infection caused by recurrent maternal infection seldom
leads to symptomatic disease at birth.4,5 Anti‑CMV IgM (human serum) in HEPES buffer, pH 7.4;
At risk for CMV infection and disease are also immunocompromised bovine albumin; preservative.
patients such as transplant recipients and HIV infected patients where the
virus can cause life-threatening diseases.11,12 The CMV status of transplant Precautions and warnings
donors and recipients is very important, as it will determine prophylactic and For in vitro diagnostic use.
pre-emptive treatment strategies against CMV. CMV‑negative transplant Exercise the normal precautions required for handling all laboratory
recipients should receive donations from CMV‑negative individuals or reagents.
leukocyte depleted blood products. CMV can reside in latency in infected Disposal of all waste material should be in accordance with local guidelines.
cells and free viral DNA load is usually low. The CMV status can still be Safety data sheet available for professional user on request.
determined by testing for CMV IgG antibodies. This kit contains components classified as follows in accordance with the
Within the appropriate clinical context, the first step in diagnosing acute Regulation (EC) No. 1272/2008:
primary CMV infection is most commonly made by the detection of
anti‑CMV‑specific IgG and IgM antibodies.5 Samples being reactive for IgM
antibodies indicate an acute, recent or reactivated infection.2,4,5,12 For further
analysis of a primary CMV infection the determination of the
CMV IgG avidity is used as an aid.2,4,5,12 A positive IgM result in
Warning