Path:
Home >
MISC >
Page351 > WS 213-2018
Price & Delivery
US$289.00 · In stock · Download in 9 secondsWS 213-2018: Diagnosis for hepatitis C
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See
step-by-step procedureStatus: Valid
WS 213: Historical versions
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| WS 213-2018 | English | 289 |
Add to Cart
|
3 days [Need to translate]
|
Diagnosis for hepatitis C
|
| WS 213-2008 | English | 359 |
Add to Cart
|
3 days [Need to translate]
|
Diagnostic criteria for viral hepatitis C
|
| WS 213-2001 | English | 319 |
Add to Cart
|
3 days [Need to translate]
|
Diagnostic criteria and principles of management of viral hepatitis C
|
Click to Preview a similar PDF
Basic data
| Standard ID | WS 213-2018 (WS213-2018) |
| Description (Translated English) | Diagnosis for hepatitis C |
| Sector / Industry | Health Industry Standard |
| Classification of Chinese Standard | C59 |
| Word Count Estimation | 12,111 |
| Date of Issue | 2018-03-06 |
| Date of Implementation | 2018-08-01 |
| Older Standard (superseded by this standard) | WS 213-2008 |
| Regulation (derived from) | State-Health-Communication (2018) 4 |
| Issuing agency(ies) | National Health Commission |
WS 213-2018: Diagnosis for hepatitis C
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Diagnosis for hepatitis C
ICS 11.020
C 59
WS
People's Republic of China Health Industry Standard
Replacing WS 213-2008
Hepatitis C diagnosis
Published on.2018 - 03 - 06
2018 - 08 - 01 implementation
National Health and Family Planning Commission of the People's Republic of China
Foreword
Chapters 6 and 8 of this standard are mandatory and the rest are recommended.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces WS 213-2008 "Diagnostic C standard for hepatitis C".
The main changes in this standard compared with WS 213-2008 are as follows.
-- The standard name was changed to "Diagnosis of Hepatitis C";
- Added normative references (see Chapter 2);
-- Revised the epidemiological history (see 4.1,.2008 version 3.1);
-- Revised clinical performance (see 3.2,.2008 version 3.2);
- modified pathology (see 4.4 and Appendix B,.2008 version 3.4);
- Revised the diagnostic principles (see Chapter 5, Chapter 4 of the.2008 edition);
- Removed suspected cases of hepatitis C (see 5.1 of the.2008 version);
-- Revised the differential diagnosis of hepatitis C in infants and young children (see 7.3, 6.4 of.2008 edition);
- Increased liver elasticity measurement content (see Appendix C);
- Added case report section (see Chapter 8 and Appendix D).
This standard was drafted. China Center for Disease Control and Prevention, STD/AIDS Prevention and Control Center, Peking University People's Hospital, Capital Medical Department
Beijing Friendship Hospital affiliated to the University, China Center for Disease Control and Prevention, Institute of Viral Diseases, Beijing Ditan Hospital, Peking University School of Medicine, China
The Third Hospital of the People's Liberation Army.
Drafters of this standard. Wang Xiaochun, Wei Lai, Jia Jidong, Liu Zhongfu, Pang Lin, Xing Wenge, Jiang Yan, Bi Shengli, Cheng Jun, Zhuang Hui, Zhao
Jingmin.
The previous versions of the standards replaced by this standard are.
--WS 213-2001;
--WS 213-2008.
Hepatitis C diagnosis
1 Scope
This standard specifies the diagnostic basis, diagnostic principles, diagnosis, differential diagnosis and case report of hepatitis C.
This standard is applicable to the diagnosis of hepatitis C at various levels of medical and health institutions and their medical staff.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document.
For undated references, the latest edition (including all amendments) applies to this document.
GB 19489 General requirements for laboratory biosafety
3 Abbreviations
The following abbreviations apply to this document.
ALT. alanine aminotransferase
APRI. aspartate aminotransferase/platelet ratio index
AST. aspartate aminotransferase
CT. computed tomography
HCV. hepatitis C virus (hepatitis C virus)
HCV RNA. hepatitis C virus ribonucleic acid
MRI. magnetic resonance imaging
PCR. polymerase chain reaction
4 diagnosis basis
4.1 Epidemiological history
Have received blood, blood products or other body tissues, cellular components, or organ transplants; history of hemodialysis, unsafe
History of shooting or other invasive procedures such as surgery, endoscopy, endoscopy, puncture, catheterization, intubation, oral consultation, acupuncture, beauty, tattoo, repair
Feet; there is a history of paid blood supply; a history of injecting drugs with shared needles; occupational exposure history; sharing of toothbrushes, razors, etc. with others
History of live contact; history of unprotected sexual contact with HCV-infected persons; mothers born with HCV infection at birth.
4.2 Clinical manifestations
Most patients had no obvious signs and symptoms, and some patients had fatigue, loss of appetite, nausea, bloating, and right rib discomfort or pain.
Some patients with acute hepatitis C may have mild hepatosplenomegaly, a few may have hypothermia or jaundice, and some may have extrahepatic manifestations such as joint pain.
Some patients with chronic hepatitis C have liver disease face, jaundice, liver palm, spider mites and mild liver and splenomegaly. Partial compensation period hepatitis C cirrhosis
The patient has liver disease face, liver palm, spider mites, jaundice and abdominal wall or esophagus, gastric varices, and splenomegaly and hypersplenism.
Decompensated patients with hepatitis C cirrhosis have a history of ascites, hepatic encephalopathy or gastrointestinal bleeding.
4.3 Laboratory examination
4.3.1 Abnormal biochemical examination. Patients with acute hepatitis C have elevated serum ALT and AST, and some patients have elevated bilirubin. Partially slow
Patients with hepatitis C and hepatitis C cirrhosis have elevated ALT, AST, and bilirubin.
4.3.2 Blood anti-HCV positive (see A.1.1 and Table A.1 in Appendix A).
4.3.3 Blood HCV RNA positive (see A.1.2 and Table A.1).
4.4 Liver histopathology
Acute, chronic hepatitis C and hepatitis C cirrhosis can present different histopathological changes (see Appendix B).
4.5 Imaging and other auxiliary examinations
4.5.1 Acute hepatitis C
Abdominal ultrasound, CT or MRI can show mild swelling of the liver and spleen.
4.5.2 Chronic hepatitis C
Abdominal ultrasound, CT or MRI can show uneven liver parenchyma, showing a slight increase in liver or spleen. APRI scores are often < 1.5.
4.5.3 Hepatitis C cirrhosis
Abdominal ultrasound, CT or MRI can show that the liver edge is not smooth or even jagged, the liver parenchyma is uneven or even nodular, and the portal vein is increased.
Wide, spleen increased. Liver elasticity measurements (see Appendix C) indicate cirrhosis. The APRI score is often >2.0.
5 Diagnostic principles
Clinical diagnosis was made based on epidemiological history, clinical manifestations, biochemical tests, and anti-HCV positive results. Based on HCV RNA positive junction
Make a diagnosis. For confirmed cases, based on the defined exposure time, the time sequence of HCV RNA, anti-HCV positive results, and
Liver histology and imaging and other auxiliary examination results can be distinguished as acute, chronic hepatitis C and hepatitis C cirrhosis.
6 diagnosis
6.1 Clinical diagnosis cases
Anti-HCV positive and meets any of the following.
a) have any of the epidemiological history;
b) have clinical manifestations;
c) There are biochemical abnormality test results.
6.2 confirmed cases
6.2.1 Cases in which blood HCV RNA is positive. Further diagnosis of acute hepatitis C and chronic hepatitis C
Diagnosis.
6.2.2 Acute hepatitis C. HCV RNA is positive and meets any of the following.
a) have a clear epidemiological history within 6 months prior to the visit;
b) clinical manifestations of acute hepatitis C;
c) liver histopathology shows the characteristics of acute hepatitis C;
d) other auxiliary examinations present the characteristics of acute hepatitis C;
e) Anti-HCV test results are negative and exclude immunosuppressive status.
6.2.3 Chronic hepatitis C. Both anti-HCV and HCV RNA are positive and meet any of the following.
a) HCV infection for more than 6 months, or an epidemiological history 6 months ago;
b) clinical manifestations of chronic hepatitis C;
c) liver histopathology is characterized by chronic hepatitis C;
d) imaging and other auxiliary examinations are characterized by chronic hepatitis C;
e) The history of epidemiology or the time of infection is unknown and acute hepatitis C has been ruled out.
6.2.4 Hepatitis C cirrhosis. Both anti-HCV and HCV RNA are positive and meet any of the following.
a) clinical manifestations of hepatitis C cirrhosis;
b) liver histopathology is characterized by hepatitis C cirrhosis;
c) Imaging and other ancillary examinations are characterized by hepatitis C cirrhosis.
7 differential diagnosis
7.1 Other viral hepatitis
The clinical manifestations and biochemical examination results of other viral hepatitis can be similar to hepatitis C. The differential diagnosis depends mainly on the corresponding other liver.
Inflammatory virology or serological test results were positive, while anti-HCV test results were negative, especially HCV RNA test results were negative.
7.2 Autoimmune diseases
Some patients with autoimmune diseases may also have positive anti-HCV test results, but usually have multiple autoantibodies, while HCV RNA
Always negative, can be identified with hepatitis C.
7.3 infant hepatitis C
The maternal IgG-type anti-HCV can enter the fetus through the placenta, and anti-HCV positivity in infants or young children within 18 months is not necessarily
Representing HCV infection, HCV RNA positive should be used as the basis for HCV infection. Newborns such as HCV infection during maternal delivery, born at 1
After weeks to 2 weeks, HCV RNA can be detected in serum, and HCV RNA is still positive after 6 months, and can be diagnosed as chronic HCV infection.
8 case report
Cases diagnosed need to be reported for infectious diseases (see Appendix D).
AA
Appendix A
(normative appendix)
Hepatitis C virus laboratory test
A.1 Detection of hepatitis C virus markers
A.1.1 Anti-HCV test
A.1.1.1 Purpose. Screening for individual HCV infection status.
A.1.1.2 Methods. including enzyme-linked immunosorbent assay, chemiluminescence assay, colloidal gold assay, and so on. According to the reagent specification
For the results, the negative and positive controls for the valid test should be in accordance with the kit.
A.1.1.3 Results report. anti-HCV antibody test, the result was negative, reported "anti-HCV negative"; the result was positive, reported "anti-HC
V positive".
A.1.2 HCV RNA detection
A.1.2.1 Purpose. HCV RNA detection for the confirmation of samples positive for HCV antibodies and screening of high-risk samples for window infections,
And as a judgment indicator of the efficacy of antiviral therapy, guide antiviral treatment and efficacy judgment.
A.1.2.2 Methods. including reverse transcription PCR, real-time PCR, and the like. According to the results of the reagent specification, the result of the negative control should be no amplification.
The curve, while the positive property control curve should be good and in accordance with the kit specifications.
A.1.2.3 Report of the results. HCV nucleic acid qualitative test results were positive, reported "HCV positive"; the results were negative, reported "HCV negative."
Nucleic acid quantitative test results report the following situations.
a) If the result is within the detection range, report directly according to the result of the test.
b) If the result is higher than the upper limit of detection, use HCV-negative mixed plasma (clear) to dilute the sample for 10 to 1 000 before re-entering
Line detection until the result falls within the detection range;
c) If the result does not show an amplification curve, it is reported as “below the lower limit of detection”. If it is below the lower limit of detection, but there is an amplification curve,
It should be re-tested. If it is within the detection limit, the report will be issued according to the actual number; if it is still below the lower detection limit, it will be reported as “lower than
Lower limit of detection".
A.2 Clinical significance of laboratory test results of hepatitis C virus
Table A.1 Clinical significance of laboratory test results for hepatitis C virus
Anti-HCV HCV RNA clinical significance
Positive positive HCV infection
Positive negative indicates previous infection, or HCV clearance after treatment
Negative positive for acute HCV infection, or immunocompromised HCV infection caused by various causes
Negative negative uninfected HCV
A.3 Hepatitis C virus laboratory testing precautions
A.3.1 Personnel requirements. Laboratory technicians need to undergo business training. After passing the examination, the relevant institutions will issue training certificates.
A.3.2 Instrument and equipment requirements. The instruments and equipment required by the state for strong inspection in the laboratory shall be determined by the same or higher level measurement and certification department.
Period verification.
A.3.3 Reagent requirements. The test reagents used in the laboratory should be registered by the State Food and Drug Administration and within the validity period.
Agent.
A.3.4 Sample requirements. The collection, storage and transportation of test samples shall comply with the relevant provisions of the health administrative department.
A.3.5 Test requirements. The specific operation steps and results of the experiment should be determined strictly according to the reagents and instrument instructions.
A.3.6 Quality control requirements. The laboratory shall establish a sound laboratory quality assurance and quality control system, and designate personnel to be responsible for the quality system.
Normal operation.
A.3.7 Laboratory biosafety requirements. The laboratory shall implement the requirements of GB 19489 and the relevant provisions of the national health administrative department.
BB
Appendix B
(informative appendix)
Liver histopathology
B.1 Acute hepatitis C
Acute hepatitis C is histologically similar to other acute viral hepatitis changes, and may have various lesions such as inflammation in the lobular and portal area, but
Usually lighter, its pathological features include.
d) a single nucleus bead-like infiltration in the hepatic sinus;
e) lymphocyte aggregation infiltration and even lymphoid follicular structure formation in the portal area;
f) visible small bile duct injury, vesicular epithelial vacuolization, apoptosis, accompanied by lymphocytic infiltration, and even the destruction of small bile duct structure, CK19
Immunohistochemical staining is helpful for identification;
g) visible hepatocyte vesicles mixed fatty streptodenosis or macrovesicular lipid changes, gene type 3, type 1 and type 4 are easier to see;
h) Acute hepatitis C has no liver fibrosis, liver cell lipids are mild or absent, and generally no interface inflammation (formerly known as debris-like necrosis).
B.2 Chronic hepatitis C
Chronic hepatitis C can be seen in different degrees of interface inflammation, lymphocyte aggregation infiltration and lymphoid follicle formation in the portal area, small bile duct
Injury; there are often varying degrees of liver fibrosis, including fibrous enlargement in the portal area, formation of fibrous septa, dysplasia of lobular structures, and even early
Hepatic cirrhosis is formed; iron particles deposition in hepatocytes can be seen in the lobule. Chronic hepatitis C disease activity and progression vary widely, and with the liver
The relationship between enzymology changes is not close, and liver biopsy is important. Masson trichrome staining and reticular fiber staining contribute to the evaluation of the degree of liver fibrosis.
Chronic hepatitis C liver tissue inflammation and necrosis classification, fibrosis degree staging, it is recommended to use the internationally used METAVIR scoring system,
Ishak or the improved Ishak scoring system.
B.3 Hepatitis C cirrhosis
On the basis of the pathological changes of chronic hepatitis C, extensive fibrous septal formation and hepatocyte nodular regeneration, ie pseudolobular formation,
According to the degree of inflammatory activity, it can be divided into active and stationary cirrhosis. It is recommended to use the Laennec cirrhosis scoring system for organization.
Academic evaluation.
Appendix C
(informative appendix)
Liver elasticity measurement
C.1 Method for measuring liver elasticity
Liver elasticity measurements can be performed by methods such as FibroScan and FibroTouch.
C.2 Precautions for liver elasticity measurement
C.2.1 The operator shall be trained in relevant specifications, and the operator shall be relatively fixed and shall not be replaced frequently to ensure the reliability of the test results.
C.2.2 When operating, first select M-type probe detection, for overweight or obese patients who cannot obtain reliable liver transient elastography, optional
Select the XL probe for testing; for narrow intercostal space or minor, S-type probe can be selected for detection.
C.2.3 The test results must meet all of the following conditions to be judged as valid. at least 10 successful tests; the total test success rate is higher than
60%; the ratio of the measured interquartile range to the median value should be < 0.3.
C.2.4 should be tested at fasting or at least 2 h after meal to reduce the effect of changes in portal blood flow on the results of the test.
C.2.5 The measured value is also affected by liver inflammation activity (expressed as elevated transaminase or bilirubin levels), extrahepatic cholestasis, hepatic vein congestion, etc.
Factor influences should be taken into account when interpreting the results.
C.2.6 In order to ensure the accuracy of the diagnosis, it is necessary to determine the low-limit value used to exclude the diagnosis and the high-limit value used to determine the diagnosis. At a high threshold
The gray area between the low-limit values is a detection range that cannot be accurately diagnosed. If clinical treatment decisions are needed, it should rely on liver biopsy.
Determine the degree of liver fibrosis, and can refer to the results of abdominal ultrasound and CT.
Appendix D
(normative appendix)
Hepatitis C case report
D.1 Hepatitis C case reporting method
Diagnosed clinically diagnosed cases and confirmed cases need to be reported in a timely manner through the legal infectious disease reporting system.
D.2 Report of clinically diagnosed cases
Cases that are anti-HCV positive and meet the diagnostic criteria for clinically diagnosed cases, if there is no HCV RNA test result, report "clinical diagnosis cases".
D.3 Report of confirmed cases
HCV RNA positive cases, regardless of anti-HCV results, report "confirmed cases".
D.4 Report of acute and chronic hepatitis C
For confirmed cases, “acute” or “chronic” hepatitis C should be further reported based on the diagnostic criteria for acute and chronic hepatitis C.
D.5 Report on child cases
For infants or young children 18 months and younger, HCV RNA positive should be used as a basis for diagnosis and reporting; HCV RNA should be reviewed 6 months later
If it is still positive, it can be diagnosed as chronic hepatitis C.
D.6 Correction of hepatitis C case report
For cases with positive anti-HCV test results but negative HCV RNA test results, no case report is required;
- "HCV test results positive report "clinical diagnosis cases", should be revised and deleted.
references
[1] World Health Organization.Guidelines for the Screening, Care and Treatment of Persons
Guidelines/en/.Accessed April,.2014.
[2] Washington State Department of Health. Hepatitis C reporting and surveillance guidelines
April 30,.2012.
[3] Omata M, Kanda T, Yu ML, et al.APASL consensus statements and management algorithms for
Hepatitis C virus infection. Hepatol Int..2012, 6(2). 409-435.
[4] European Association for the Study of the Liver.EASL clinical practice guidelines.
Management of hepatitis C virus infection.J Hepatol.2011,55(2).245-264.
[5] Liver Hardness Assessment Group. Experts on the diagnosis of liver fibrosis by transient elastography. Chinese Journal of Hepatology.
2013, 21(6). 420-424.
...
