Intended Use
For the detection of IgG antibodies to HHV-6 in human serum isolated from venous or capillary blood.
Storage
The ELISA kit should be used within three months after opening.
Store the kit and the kit reagents at +2 to +10°C, in a dry place and protected from the light. Store unused strips in the sealable pouch and keep the desiccant inside. Store serum samples at +2 to +10°C up to one week. For longer period make aliquots and keep them at -20°C. Avoid repeated thawing and freezing. Do not store diluted samples. Always prepare fresh.
Kits are shipped in cooling bags, the transport time of 72 hours have no influence on expiration. If you find damage at any part of the kit, please inform the manufacturer immediately.
Expiration date is indicated at the ELISA kit label and at all reagent labels.
Performance Characteristics
The kit is intended for the qualitative and semiquantitative detection of anti-HHV-6 IgG antibodies in human serum and plasma. Suitable specimens are serum and plasma (heparinised) samples obtained by standard laboratory techniques.
Validity of the test
The absorbance value of the Dilution buffer DIL (DIL = reaction background) should be < 0.150.
The OD values of the standards / control sera and the ratio of the OD values of the standards ST E/PC / ST D/CAL should be within the ranges stated in the Quality Control Certificate of the lot.
The Calibrator and Controls are human sera, and as such they may show inhomogeneity, if their value in the test is significantly different from the values stated in the Certificate of analysis, consult the results with the manufacturer.
Precision
The interassay variability (between tests) and the intraassay variability (within the test) were determined by testing samples with different OD values.
IntraassayThe variation coefficient of intraassay is max. 8 %. It is measured for each particular lot at least on 12 parallels of the same microtiter plate.
InterassayThe variation coefficient of reproducibility is a maximum of 15 %. It is measured for each lot by comparing the wells of the same sample in several consecutive tests.

General Description
The kits is intended for serological diagnosis of diseases associated with HHV–6 infection, such as exanthema subitum, acute respiratory illnesses, diarrhoea with fever and febrile seizures in infants, heterophile antibody-negative infectious mononucleosis in children, also interstitial pneumonia, encephalitis, meningitis, hepatitis and aplastic anemia in immunodeficient patients. The presence of IgG anti-HHV-6 antibody reveals the immune status of the patient. Significant rise in anti-HHV-6 IgG antibodies in paired serum samples, taken in acute and convalescent phase of the infection, is indicative of the active infection. The test does not differentiate between HHV-6 subtype A and B.
Citations
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