1. Data from Quality Control test:
2. Validity of the test
The test is valid if:
The background of the reaction (the absorbance of the Dilution buffer) is less than 0.100.
The ratio of Negative control absorbance cut off is lower than 0.9.
The ratio of Positive control absorbance cut-off is higher than 1.1.
The mean absorbance value of Standard 1 is 1.928 for this kit lot, which in the range acceptable OD range:1.400-2.300.
3. Precision of the test
The intra-assay and the inter-assay reproducibility were determined using samples with different absorbance values. In anti-HHV6 IgG-positive samples intra-assay and inter-assay variability coefficients (CV) did not exceed 5% and 15% of mean absorbance values, respectively.
4. Sensitivity and specificity of the test
The sensitivity of the test is 99% and the specificity is 95%. Evaluation was performed by the comparing the HHV-6 IgG ELISA Kit with other commercial ELISA tests.
5. Spiking recovery test
Measured values of recovery test for every Lot are between 80-120% of expected values.
Haemolytic and lipemic samples have no influence on the test results up to concentration of 50 mg/mL of haemoglobin, 5 mg/mL of bilirubin and 50 mg/mL of triglycerides. However, examination of such samples is not recommended.