Cytomegalovirus (CMV) IgM ELISA

Sample

Human serum or EDTA, heparin or citrate plasma

Species Reactivity

Human

Detection Method

iELISA

Intended Use

The ELISA kit is intended for the diagnosis of CMV-caused or CMV-associated diseases such as infectious mononucleosis, CMV syndrome or acute and chronical CMV infection in immunocompromised patients. The kit can also be used for complex characterization of chronic fatigue syndrome and for the determination of CMV seropositivity in blood and organs donors and recipients of these biological materials.

Contents of Kit

1.ELISA 8-well break-away strips coated with a mixture of specific recombinant antigens 1x12pcs.
2.Negative control serum¹⁾, r.t.u., 1.3 mL,1 vial
3.Positive control serum, r.t.u., 1.3 mL, 1 vial
4.Calibrator, r.t.u, 1.3 mL, 1 vial
5.Anti-human IgM antibodies labelled with horseradish peroxidase r.t.u., 13mL, 1vial
6.Wash buffer 10x concentrated, 55 mL, 1vial
7.Dilution buffer r.t.u., 60 mL 1vial
8.Chromogenic substrate TMB, r.t.u., 13 mL, 1vial
9.Stop solution r.t.u. 13 mL, 1vial
10.RF sorbent²⁾, 25x concentrated, 2 mL, 1vial
11.Instruction manual
12.Quality control certificate
¹⁾ (ready to use)
²⁾ Goat anti-human IgG globulin
Notice: Control sera may be colorless to yellowish or blue due to the use of different diluents.
Chromogenic substrate TMB) is compatible and interchangeable between ELISA-CD kits which contain [TMB and not compatible with other Chromogenic substrates used in other ELISA-CD TMB-O, TMB-BF

Storage

The ELISA kit should be used within three months after opening.
a. Store the kit and the kit reagents at +2 to +10°C, in a dry place and protected from the light. Under these conditions, the expiration period of the entire kit is indicated on the central label, the expiration date of the individual components is indicated on their package labels.
b. Store unused strips in the sealable pouch and keep the desiccant inside.
c. Kits are shipped in cooling bags, the transport time up to 72 hours have no influence on expiration. If you find damage at any part of the kit, please inform the manufacturer immediately.
d. Store undiluted sera in aliquots at -18 to -28 °C. Frequent freezing and thawing is not recommended. Undiluted serum samples could be stored at +2 to +10°C up to one week.
e. Do not store diluted samples. Always prepare fresh.

Performance Characteristics

Validity of the test
The test is valid if:
The background absorbance (the absorbance of the DIL PLUS) is less than 0.150.
The mean absorbance values of standards/ control sera, and the ratio between the absorbance values of PC / CAL are in the ranges stated in the Quality control certificate for this kit lot.

Precision

Intra-assay precision:<8%
Inter-assay precision:<15%