hepatitis virus b (hbv) is the causative agent of acute and chronic hepatitis. approximately 400 million people worldwide are chronically infected with hbv. there are 170 million people infected in china. hbv infection can lead to cirrhosis and primary hepatocelluar carcinoma.
hbv pcr fluorescence quantitative diagnostic kit combines the technologies of nucleic acid amplification and hybridization probe to detect hbv dna in serum of human being, which could assist diagnoses of hbv disease.

features
1.using the submicro paramagnetic particles to extract and purify hbv dna form all kinds of sample and can be applied in bioer’s nucleic acid purification systerm(npa-32). it ensures the extraction consistency of one batch quality control substance and the sample’s hepatitis virus b copy number. for the fluorescence quantitative pcr system doing quantity judgement basing on quality control substance, it greatly enhances detection veracity.
2.based on bioer’s flurescence quantitative pcr detection system.
due to adopt mgb probe technique, it increases the fluorescence resolution power and the stability of the probe, and then increases the detection resolution power.
leading the competitive internal standard method into hbv fluorescence quantitative pcr detection system, we can remove false negative results directly.
3.the magnetism extraction method can process the samples, which the traditional methods aren’t able to process, such as blood samples processed by anticoagulant and the hemolysis samples. it explores greatly the kit’s applied range.
4.use dutp-ung system: effectively prevent carryover contamination in pcr.

applications:
1. sensitivity experiment
ten times dilution for one sample, and dilute three times

2.precision experiment
take 10 pcs. clinic or simulation samples which contain different quantity of pathogens, including strong-positive, critical-positive and under critical samples, and 3 pcs. reference substance inner the kit to 3 labs separately, do 3 times repeat tests for each sample, and then do the result statistics.

got the precision result from 3 labs, the standard deviation of the mean of the mean is 0.19, the max. log-standard deviation is 0.35, average cv value is 3.66%, the max. cv value is 5.49%
the brief summary of this experiment: the standard deviation and cv value is on the small side. it means the precision is good.
3. the detection result from national institute for the control of pharmaceutical and biological products of p.r. china
l0~l5 are hbv dna quantitative linearity sensitivity reference substances (l0~l5), which separately are 1×108~1×103 iu/ml
statistic: judgment of test’s validity: test is valid, r=-1.000≤0.970. linearity sensitivity(l0~l5) detection result:
① iu number (iu/ml)

② calculate r value: do regression analysis for the double logarithmic of theoretical value and measured value to calculate r value

r=1.00

order information