Test directory: AFP/HBV DNA, Quant/HBeAg

Ordering Code2315
Test NameAFP/HBV DNA, Quant/HBeAg
Profile Contains
Preferred Container3 SS (Serum/Separator - Red/Grey or Gold)
Avail. StatNO

Reference range(s) for Hepatitis Be Antigen

The reference ranges listed below are valid on this date of April 26, 2024.
ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
Hepatitis Be AntigenALLNEGATIVENEGATIVE

Reference range(s) for Hepatitis B DNA, Quant.

The reference ranges listed below are valid on this date of April 26, 2024.
ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
Hepatitis B DNA, QuantALLNOT DETECTEDNOT DETECTED

The linear...
The linear range for the cobas (R) HBV for a 500 uL sample processing volume for EDTA plasma and serum is from 10 IU/mL to 1.00E+09 IU/mL with an accuracy within +/-0.24 log10
The lower limit of quantification (LLoQ) is 10 IU/mL

The limit of detection (LoD) of cobas (R) HBV for 500 uL sample processing volume is 6.6 IU/mL for EDTA plasma and 3.5 IU/mL for serum. The same LoD has been verified for genotypes A through H and the predominant precore mutant

Reliable results depend on proper sample collection, storage and handling procedures. Quantitation of HBV DNA is dependent on the number of virus particles present in the samples and may be affected by sample collection methods, patient factors (i.e. age, presence of symptoms), and/or stage of infection
Note1
HBV-DNAALL<10<10IU/mL
HBV-DNAALL<1.0<1.0Log IU/mL

Note1:


The linear range for the cobas (R) HBV for a 500 uL sample processing volume for EDTA plasma and serum is from 10 IU/mL to 1.00E+09 IU/mL with an accuracy within +/-0.24 log10
The lower limit of quantification (LLoQ) is 10 IU/mL

The limit of detection (LoD) of cobas (R) HBV for 500 uL sample processing volume is 6.6 IU/mL for EDTA plasma and 3.5 IU/mL for serum. The same LoD has been verified for genotypes A through H and the predominant precore mutant

Reliable results depend on proper sample collection, storage and handling procedures. Quantitation of HBV DNA is dependent on the number of virus particles present in the samples and may be affected by sample collection methods, patient factors (i.e. age, presence of symptoms), and/or stage of infection
.

Reference range(s) for AFP Non-Maternal, Serum

The reference ranges listed below are valid on this date of April 26, 2024.
ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
AFP Non-Maternal, SerumALL0.0-9.00.0-9.0ng/mL

Elevated AFP...
Elevated AFP values have been observed in several malignant diseases, such as nonseminomatous testicular cancer, and primary hepatocellular carcinoma. Not to be used in determining neural tube defects. Expected values for children have not been established

Results were obtained with the Elecys AFP assay. Results from assays of other manufacturers cannot be used interchangeably
Note1

Note1:


Elevated AFP values have been observed in several malignant diseases, such as nonseminomatous testicular cancer, and primary hepatocellular carcinoma. Not to be used in determining neural tube defects. Expected values for children have not been established

Results were obtained with the Elecys AFP assay. Results from assays of other manufacturers cannot be used interchangeably
.