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viral hepatitis

Laboratory：Akiruno

○viral hepatitis

TEST NAME	SPECIMEN REQUIREMENT （ｍL）	CONTAINER	CAP COLOR	STORE TEMPERATURE (STABILITY)	TURNAROUND TIME (DAY)	METHODOLOGY	REFERENCE RANGE (UNIT)
HBV genotype	Serum 0.6	S09 ↓ A00			2-4	Enzyme immunoassay(EIA) EIA (Enzyme immunoassay) Enzyme immunoassay The measurement principle is the same as RIA; an antigen-antibody reaction is performed using an enzyme-labeled antigen or antibody as a labeling substance, and a chromogenic substrate is added to detect enzyme activity. How to measure.
HBV DNA quantitative (IU)	Serum 1.8	S5F		（21 days）	3-5	PCR (Real Time PCR) Real-time PCR A type of nucleic acid amplification method based on the basic principle of PCR, which uses oligonucleotides that emit fluorescence upon decomposition to quantify target nucleic acids in real time by checking the fluorescent signal at each PCR cycle. A measurement method that enables	Not detected (Log IU/mL)
HBs antigen (HQ)	Serum 0.6	S09 ↓ A00		（21 days）	2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	Less than 0.005 (IU/mL)
HBs antibody〔CLEIA〕	Serum 0.5	S09 ↓ A00			2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	Less than 10.0 (mIU/mL)
HBs antibody	Serum 0.2	S09 ↓ A00			2-4	PHA PHA (Passive hemagglutination) Passive hemagglutination Antibodies are reacted using sensitized red blood cells with antigen adsorbed (bound) on the surface of the red blood cells, and the presence of antibodies is determined by the presence or absence of agglutination due to antigen-antibody reaction. How to judge.	Less than 8 (X)
Hepatitis B virus core antigen (HBcrAg)	Serum 0.5	S09 ↓ A00			2-5	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	Less than 2.1(LogU/mL)
HBc antibody (IgG)	Serum 0.3	S09 ↓ A00			2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	C.O.I. less than 1.0
IgM-HBc antibody	Serum 0.5	S09 ↓ A00			2-4	CLIA CLIA (Chemiluminescent immunoassay) Chemiluminescent immunoassay method After reacting the antigen with the immobilized antibody, the antibody labeled with a chemiluminescent substance is caused to react with the antigen for a second time to generate chemiluminescent A method for measuring the luminescence intensity of substances.	S/CO Less than 1.00
HBc antibody	Serum 0.3	S09 ↓ A00			2-4	PHA PHA (Passive hemagglutination) Passive hemagglutination Antibodies are reacted using sensitized red blood cells with antigen adsorbed (bound) on the surface of the red blood cells, and the presence of antibodies is determined by the presence or absence of agglutination due to antigen-antibody reaction. How to judge.	Negative (less than 64)(X)
HBe antigen	Serum 0.5	S09 ↓ A00			2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	C.O.I. less than 1.0
HA antibody	Serum 0.7	S09 ↓ A00			2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	INHIBITION Less than 60 (%)
HA antibody	Serum 0.4	S09 ↓ A00			2-4	CLIA CLIA (Chemiluminescent immunoassay) Chemiluminescent immunoassay method After reacting the antigen with the immobilized antibody, the antibody labeled with a chemiluminescent substance is caused to react with the antigen for a second time to generate chemiluminescent A method for measuring the luminescence intensity of substances.	See below
IgM-HA antibody	Serum 0.4	S09 ↓ A00			2-4	CLIA CLIA (Chemiluminescent immunoassay) Chemiluminescent immunoassay method After reacting the antigen with the immobilized antibody, the antibody labeled with a chemiluminescent substance is caused to react with the antigen for a second time to generate chemiluminescent A method for measuring the luminescence intensity of substances.	See below
HCV antibody (3rd generation)	Serum 0.7	S09 ↓ A00			2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	Less than 1.0(-) (COI)
By HCV group (grouping)	Serum 0.5	S09 ↓ A00			2-4	CLEIA CLEIA (Chemiluminescent enzyme immunoassay) Chemiluminescent enzyme immunoassay After reacting the antigen with the immobilized antibody, the enzyme-labeled antibody is subjected to a secondary reaction with the antigen, and a chemiluminescent substrate is added. method to measure luminescence intensity.	(Group)
HCV RNA core genotype	Serum 0.5	S3F,S5F		（3 month）	3-5	RT-PCR RT-PCR (Reverse transcriptase-polymerase chain reaction) A method of PCR in which complementary cDNA is synthesized using reverse transcriptase (RT) using RNA as a template when RNA is the target of amplification.	Not detected
HCV RNA quantitative	Serum 1.8	S5F		（21 days）	3-5	RT-PCR (Real Time PCR) Real-time PCR A type of nucleic acid amplification method based on the basic principle of PCR, which uses oligonucleotides that emit fluorescence upon decomposition to quantify target nucleic acids in real time by checking the fluorescent signal at each PCR cycle. A measurement method that enables	Not detected (Log IU/mL)
HCV antigen (core protein)	Serum 0.8	S09 ↓ A00			2-4	CLIA CLIA (Chemiluminescent immunoassay) Chemiluminescent immunoassay method After reacting the antigen with the immobilized antibody, the antibody labeled with a chemiluminescent substance is caused to react with the antigen for a second time to generate chemiluminescent A method for measuring the luminescence intensity of substances.	Less than 3.0 (lower limit of quantification) (fmol/L)
IgA-HEV antibody (qualitative)	Serum 0.3	S09 ↓ A00			2-5	Enzyme immunoassay(EIA) EIA (Enzyme immunoassay) Enzyme immunoassay The measurement principle is the same as RIA; an antigen-antibody reaction is performed using an enzyme-labeled antigen or antibody as a labeling substance, and a chromogenic substrate is added to detect enzyme activity. How to measure.	Negative
HBV DNA quantification（Suspended beyond orders placed 04-03-2017）	Serum 1.8	S5F				PCR (Real Time PCR) Real-time PCR It is a type of nucleic acid amplification methods based on PCR method as the basic principle, which is a measurement method that, by using oligonucleotides that emit fluorescence when degraded, enables quantitative of target nucleic acids in real time by confirming the fluorescence signals in each PCR cycle.	Not detected (Log IU/mL)
HBs antigen〔CLIA〕（Suspended beyond orders placed 01-06-2017）	Serum 0.5	S09 ↓ A00				CLIA CLIA (Chemiluminescent immunoassay) A method in which after an antigen is reacted with a solid-phase antibody, an enzyme-labeled antibody is reacted with the antigen in a secondary reaction, in which the luminescence intensity of a chemiluminescent substrate is measured.	Less than 0.05 (IU/mL)
HBs Antigen（Suspended beyond orders placed 03-31-2021）	Serum 0.2	S09 ↓ A00			2-4	Magnetized particle aggregation method (MAT method)	Negative (less than 8) (x)
HBc antibodies（Suspended beyond orders placed 01-06-2017）	Serum 0.3	S09 ↓ A00				CLIA CLIA (Chemiluminescent immunoassay) A method in which after an antigen is reacted with a solid-phase antibody, an enzyme-labeled antibody is reacted with the antigen in a secondary reaction, in which the luminescence intensity of a chemiluminescent substrate is measured.	Less than 1.00 (-)
HCV DCV resistant mutation (L31/Y93)（Suspended beyond orders placed 02-20-2023）	Serum 0.5	S3F,S5F		（21 days）	10-14	Direct sequencing method and Cycleave PCR method
HCV RNA 1b (NS5A)（Suspended beyond orders placed 02-20-2023）	Serum 0.5	S3F,S5F		（3 months）	10-14	Sanger method	AA2209-2248 Not detected (number of variants)
HCV drug resistance mutation NS3-D168（Suspended beyond orders placed 02-18-2023）	Serum 0.5	S3F,S5F		（21 days）	10-14	Direct sequence method Direct sequence method A method of directly determining the base sequence using DNA amplified by PCR method as a template.
HCV NS5B-S282 mutation（Suspended beyond orders placed 02-20-2023）	Serum 0.5	S3F,S5F		（21 days）	Please confirm in advance	Direct sequence method Direct sequence method A method of directly determining the base sequence using DNA amplified by PCR method as a template.
HBV DNA Lamivudine Resistance Gene（Suspended beyond orders placed 06-24-2019）	Serum 0.5	S3F,S5F		（21 days）	4-10	PCR-ELMA

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