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WS/T 293-2019 English PDF

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WS/T 293-2019: (AIDS and HIV infection diagnosis)

WS/T 293: Evolution and historical versions

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WS/T 293-2019English439 Add to Cart 4 days [Need to translate] (AIDS and HIV infection diagnosis) WS/T 293-2019
WS/T 293-2019English439 Add to Cart 4 days [Need to translate] (AIDS and HIV infection diagnosis) WS/T 293-2019
WS 293-2018EnglishRFQ ASK 3 days [Need to translate] Diagnosis for HIV／AIDS WS 293-2018
WS 293-2008English759 Add to Cart 4 days [Need to translate] Diagnostic criteria for HIV/AIDS Obsolete WS 293-2008

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Standard similar to WS/T 293-2019

GB 15979   GB/T 15981   WS/T 641   WS/T 283   WS 283   

Basic data

Standard ID WS/T 293-2019 (WS/T293-2019)
Description (Translated English) (AIDS and HIV infection diagnosis)
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C59
Word Count Estimation 19,116
Issuing agency(ies) National Health Commission

WS 293-2018: Diagnosis for HIV／AIDS

---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 HIV/AIDS ICS 11.020 C 59 WS People's Republic of China Health Industry Standard WS 293-2019 Replace WS 293-2008 AIDS and HIV infection diagnosis 2019-01-02 released 2019-07-01 implementation Issued by the National Health Commission of the People's Republic of China WS 293-2019

Foreword

Chapter 6 of this standard is mandatory clauses, and the rest are recommended clauses. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces WS 293-2008 "Diagnostic Standards for AIDS and HIV Infection". Compared with WS 293-2008, the main technical changes of this standard are as follows. -Revised the definition of the term "HIV-infected person" (see 2.3, 2.3 of the.2008 edition) - Delete the terms "incubation period" and "S/CO value" (see 2.5 and 2.12 in the.2008 edition); -The term "serum positive conversion" was changed to "HIV serum antibody positive conversion" (see 2.7,.2008 version of 2.8) -Modified the definition of the term "window period" (see 2.8, 2.9 of the.2008 edition); -Modify the definition of the term "HIV antibody screening test" (see 2.10, 2.11 of the.2008 edition); -Modify the term "HIV antibody confirmation test" to "HIV supplemental test" and its definition (see 2.11, 2.13 in the.2008 edition); --The terms "CD4 T lymphocyte count" and "CD4 T lymphocyte percentage" have been added (see 2.12, 2.13); -Deleted the term "highly active antiretroviral therapy" (see 2.14 of the.2008 edition); - The term "history of iatrogenic infection" was changed to "history of iatrogenic exposure" (see 2.15 and 4.1.4, and 2.21 and 4.1.4 in the.2008 edition); - The term "clinical manifestations" was deleted, the term "HIV encephalopathy" was changed to "HIV-related neurological symptoms", and the related clinical The definition of bed symptoms has been moved to Appendix A (see Appendix A, A.1~A.5, and.2008 version 2.15~2.19, 2.22); - Added the acronym CPs, VL (see Chapter 3); - Delete the acronym HAART (see Chapter 3); - Modified the clinical manifestations of HIV infection, and moved the specific description to Appendix A (see 4.2 in the.2008 edition); - Modified the description of serological test results from "positive"/"negative" to "reactive"/"non-reactive" (see 4.3.2.1, 4.3.1 of the.2008 edition); -Modified HIV nucleic acid test "test result positive" to "nucleic acid qualitative test result positive or quantitative test > 5 000 CPs/mL" (See 4.3.3.2, 4.3.2.2 of the.2008 edition); - Modified "CD4 cell detection" to "immunological detection" (see 4.3.4, 4.3.3 of the.2008 edition); -Modified the diagnostic criteria classification of HIV-infected persons "adults and adolescents over 15 years old" to "adults, adolescents and 18 "Children over the age of 15 months" and "children under 15" are "children 18 months and under", and the diagnostic criteria have been revised, Include nucleic acid testing into the diagnostic criteria (see 6.1, 6.1 of the.2008 edition); -Revised the "Clinical staging of HIV/AIDS" (see Chapter 7, Chapter 7 of the.2008 edition); -Added Appendix A clinical manifestations of HIV infection; -Amended Appendix B (see Appendix A of the.2008 edition). Drafting organizations of this standard. China Center for Disease Control and Prevention, STD and AIDS Prevention and Control Center, Peking Union Medical College Hospital, China Medical University, Shanghai Center for Disease Control and Prevention, Academy of Military Medicine of the Chinese People's Liberation Army Academy of Military Sciences, Beijing Ditan Doctor, Capital Medical University Hospital, Beijing You’an Hospital Affiliated to Capital Medical University, China Institute for Food and Drug Control, Yunnan Provincial Center for Disease Control and Prevention, National Health Clinical Laboratory Center of the Health Commission, Guangzhou Eighth People's Hospital, Beijing Entry-Exit Inspection and Quarantine Bureau, Henan Provincial Center for Disease Control and Prevention. The main drafters of this standard. Shao Yiming, Wang Ning, Li Taisheng, Zhang Fujie, Shang Hong, Kang Laiyi, Zhong Ping, Li Jingyun, Jiang Yan, Zhao Hong Xin, Wu Hao, Wang Youchun, Jia Manhong, Wang Lunan, Cai Weiping, Zhu Hong, Wang Zhe, Xiao Yao, Liang Hua, Liao Lingjie, Mu Weiwei, Wu Yingqi. The previous versions of the standard replaced by this standard are as follows. --WS 293-2008. WS 293-2019 AIDS and HIV infection diagnosis

1 Scope

This standard specifies the diagnostic basis, principles, diagnosis and clinical staging of AIDS and HIV infection. This standard applies to the diagnosis of AIDS and HIV infection by various medical and health institutions at all levels and their staff throughout the country.

2 Terms and definitions

The following terms and definitions apply to this document. 2.1 HIV human immunodeficiency virus; HIV Human immunodeficiency virus The pathogen that causes AIDS. 2.2 AIDS acquired immunodeficiency syndrome; AIDS Acquired Immune Deficiency Syndrome Progressive immune deficiencies characterized by the reduction of human CD4 T lymphocytes caused by HIV infection, which can be secondary to the later stages of the disease A comprehensive disease of opportunistic infections, malignant tumors and central nervous system diseases. 2.3 HIV infected person Individuals who have not yet developed AIDS after being infected with HIV. 2.4 AIDS patient Patients who develop AIDS after being infected with HIV. 2.5 CD4 CD4 positive T lymphocyte Helper T lymphocytes expressing CD4 molecules are the main target cells for HIV infection. 2.6 Opportunistic infection WS 293-2019 An infectious disease that occurs when the immune function is weakened. 2.7 HIV seroconversion HIV seroconversion After being infected with HIV, the HIV antibody in the body's serum turns from non-responsive to reactive. 2.8 Window period The period from HIV infection to the time before the HIV antibody, antigen or nucleic acid in the serum of the infected person can be detected. Note. The blood in the window period has become infectious. The window periods for the detection of HIV antibodies, antigens and nucleic acids by existing diagnostic techniques are 3 weeks, 2 weeks and 1 week after infection respectively. About weeks. 2.9 Viral load The amount of HIV RNA in the patient’s plasma (clear) is an indicator of HIV nucleic acid quantitative detection. The test results are based on HIV RNA per milliliter of plasma (clear) The number of copies or international units (CPs/mL or IUs/mL). 2.10 HIV antibody screening test A type of testing methods for preliminary understanding of the presence or absence of HIV antibodies in the body's blood or body fluids also includes methods for simultaneously testing HIV antibodies and antigens. Note. The test results in response or no response to HIV antibody or antigen. Commonly used detection methods include enzyme-linked immunosorbent assay (ELISA), chemiluminescence or immunoassay Epidemic fluorescence test, immunoagglutination test, immunochromatography test, immunofiltration test and combined detection test of antigen and antibody. 2.11 HIV supplementary test After obtaining the screening test results, in order to make accurate judgments, continue to detect the presence of HIV antibodies or nucleic acids in the body’s blood or body fluids. Including antibody confirmation test and nucleic acid test. Note. Antibody confirmation test includes western blot test, band/linear immunoassay, immunochromatography test, immunofiltration test and alternative test under specific conditions Nucleic acid test includes qualitative nucleic acid test and quantitative nucleic acid test. 2.12 CD4 CD4 positive T lymphocyte count The number of CD4 T lymphocytes in peripheral blood per cubic millimeter (or per microliter). 2.13 CD4 CD4 positive T lymphocyte percentage The percentage of CD4 T lymphocytes in peripheral blood to total lymphocytes. 2.14 WS 293-2019 Occupational exposure history People who are engaged in AIDS prevention and treatment or may be exposed to HIV have a history of accidental contact with HIV at work. 2.15 Nosocomial exposure history Have a history of unsafe injections, punctures, or surgery during diagnosis and treatment, or have received blood, blood products, or tissues that have not been tested for HIV Or the history of the organ.

3 Abbreviations

The following abbreviations apply to this document. AIDS. AIDS (acquired immunodeficiency syndrome) CPs. number of copies (copies) HIV. human immunodeficiency virus (human immunodeficiency virus) PGL. Persistent generalized lymphadenopathy (persistent generalized lymphadenopathy) VL. viral load (viral load)

4 Diagnosis basis

4.1 Epidemiological history 4.1.1 Suffer from sexually transmitted diseases or have a history of sexually transmitted diseases. 4.1.2 Unsafe sex (including homosexual and heterosexual sexual contact). 4.1.3 Have a history of drug use by sharing syringes. 4.1.4 There is a history of iatrogenic exposure. 4.1.5 Have a history of occupational exposure. 4.1.6 Spouses or sexual partners of HIV/AIDS patients. 4.1.7 Children born to HIV/AIDS mothers. 4.2 Clinical manifestations (see Appendix A for various clinical manifestations) 4.2.1 Acute HIV infection syndrome (see Appendix A.1). 4.2.2 PGL (see Appendix A.2). 4.2.3 Clinical manifestations of mild immune system deficiency. a) Adults and adolescents over 15 years old (including 15 years old). Group A clinical manifestations (see Appendix A.6.1.1). b) Children under 15.Clinical manifestations of group D (see Appendix A.6.2.1). 4.2.4 Clinical manifestations of moderate immune system deficiency. WS 293-2019 a) Adults and adolescents over 15 years old (including 15 years old). clinical manifestations of group B (see Appendix A.6.1.2). b) Children under 15.Clinical manifestations of group E (see Appendix A.6.2.2). 4.2.5 The clinical manifestations of severe immune system deficiency are indicative diseases of AIDS, including opportunistic infections, tumors and HIV-related diseases. System symptoms. a) Adults and adolescents over 15 years old (including 15 years old). Clinical manifestations of group C (see Appendix A.6.1.3). b) Children under 15.Clinical manifestations of group F (see Appendix A.6.2.3). 4.3 Laboratory testing (see Appendix B for specific instructions on various HIV laboratory testing techniques) 4.3.1 General Due to the window period for testing, laboratory testing needs to comprehensively apply antibody testing, nucleic acid testing and HIV virus isolation tests according to the situation. 4.3.2 Serological testing (see Appendix B.1) 4.3.2.1 HIV antibody screening test The results of the screening test are positive, suggesting that the HIV antibody may be positive, and further supplementary tests are needed to confirm. Screening test results are positive Yes, report HIV antibody negative. 4.3.2.2 HIV antibody confirmation test 4.3.2.2.1 Judgment of HIV antibody confirmation test results a) HIV-1 antibody positive (), which must meet one of the following criteria. 1) At least 2 env bands (gp41 and gp160/gp120) appear, or at least 1 env band and at least 1 gag or pol With simultaneous appearance 2) Meet the positive judgment standard provided by the HIV antibody confirmation kit approved by the country. b) HIV-2 antibody positive (), which must meet one of the following criteria. 1) At least 2 env bands (gp36 and gp140/gp105); 2) Meet the positive determination criteria provided by the HIV antibody confirmation kit approved by the state. c) HIV antibody negative (-). no HIV antibody-specific band appears. d) Uncertain HIV antibody (±). HIV antibody-specific bands appear, but not enough to determine the positive. 4.3.2.2.2 Treatment of HIV antibody confirmation test results Confirmation test result is positive, report HIV antibody is positive; Confirmation test result is negative, report HIV antibody is negative; Confirmation test result is inaccurate It is determined that the report of HIV antibody is uncertain, and it is recommended to follow up after 2 to 4 weeks or do an HIV nucleic acid test as soon as possible. 4.3.3 Pathogen detection 4.3.3.1 HIV virus isolation test (see Appendix B.2) A positive test result reports HIV infection, a negative test result cannot rule out HIV infection. 4.3.3.2 HIV nucleic acid test (see Appendix B.3) A positive nucleic acid qualitative test result or a quantitative test > 5 000 CPs/mL indicates HIV infection. A negative result cannot exclude HIV infection. 4.3.4 Immunological testing (see Appendix B.4) WS 293-2019 4.3.4.1 Detection classification Immunological testing is the main testing index for staging and judging the curative effect of HIV infection and AIDS, mainly using CD4 T lymphocyte testing. The test is divided into two types. CD4 T lymphocyte count and percentage. 4.3.4.2 CD4 T lymphocyte count Suitable for adults and children and adolescents over 5 years old. The CD4 T lymphocyte count of this population is ≥500/mm3, indicating no immunodeficiency; 350/mm 3～499/mm3, suggesting mild immunodeficiency;.200/mm3～349/mm3, suggesting moderate immunodeficiency; < 200/mm3, suggesting severe Immunodeficiency. 4.3.4.3 CD4 Percentage of T lymphocytes Suitable for children 5 years old and below. The percentage of CD4 T lymphocytes in peripheral blood T cells in this population> 35% (< 12 months old), or> 30% (12 months to 36 months old), or> 25% (37 months to 60 months old), suggesting no immunodeficiency; 30% to 35% (< 12 months old), or 25% to 30% (12 months to 36 months old), or 20% to 25% (37 months to 60 months old), suggesting mild immunodeficiency; 25% to 29% (< 12 months old), Or 20% to 24% (12 months to 36 months old), or 15% to 19% (37 months to 60 months old), suggesting moderate immunodeficiency; < 25% (< 12 Months old), or < 20% (12 months to 36 months old) or < 15% (37 months to 60 months old), suggesting severe immunodeficiency.

5 Principles of diagnosis

The diagnosis principle of HIV/AIDS is based on laboratory testing, combined with clinical manifestations and reference epidemiological data. HIV resistance Physical and pathogenic tests are the basis for the diagnosis of HIV infection; epidemiological history is an important reference for the diagnosis of acute HIV infection in infants and young children; CD4 T Lymphocyte detection and clinical manifestations are the main basis for the staged diagnosis of HIV infection; the indicative disease of AIDS is an important basis for the diagnosis of AIDS.

6 Diagnosis

6.1 HIV infection 6.1.1 Adults, adolescents and children over 18 months of age It can be diagnosed if one of the following is met. a) HIV antibody screening test responds and HIV antibody confirmation test is positive; b) HIV antibody screening test is positive and nucleic acid qualitative test is positive; c) HIV antibody screening test has response and nucleic acid quantitative test >5000 CPs/mL; d) Have epidemiological history or AIDS-related clinical manifestations, and both HIV nucleic acid tests were positive; e) HIV isolation test is positive. 6.1.2 Children 18 months and younger It can be diagnosed if one of the following is met. a) Birth to an HIV-infected mother and both HIV nucleic acid tests are positive (the second test needs to be sampled 4 weeks after birth); b) History of iatrogenic exposure, positive HIV isolation test result or both HIV nucleic acid tests are positive; c) Born to HIV-infected mothers and HIV isolation test is positive. 6.2 AIDS WS 293-2019 6.2.1 Adults and adolescents over 15 years old (including 15 years old) It can be diagnosed if one of the following is met. a) HIV infection and CD4 T lymphocyte count < 200/mm3; b) HIV infection and at least one disease indicative of adult AIDS (see Appendix A.6.1.3). 6.2.2 Children under 15 It can be diagnosed if one of the following is met. a) The percentage of HIV infection and CD4 T lymphocytes < 25% (< 12 months old), or < 20% (12 months to 36 months old), or < 15% (37 months to 60 months old), or CD4 T lymphocyte count < 200/mm3 (5 years to 14 years old); b) HIV infection and at least one disease indicative of childhood AIDS (see Appendix A.6.2.3). 7 Clinical staging of HIV/AIDS 7.1 Adults and adolescents over 15 years old (including 15 years old) 7.1.1 Stage I (early stage of HIV infection) People with HIV infection can be diagnosed if they meet one of the following. a) Epidemiological history and/or acute HIV infection syndrome and/or PGL within 3 months to 6 months; b) The antibody screening test did not respond, and both nucleic acid tests were positive; c) A positive conversion of HIV serum antibodies occurred within one year. 7.1.2 Stage II (intermediate stage of HIV infection) People with HIV infection can be diagnosed if they meet one of the following. a) CD4 The T lymphocyte count is.200/mm3～500/mm3; b) Asymptomatic or at least one clinical manifestation in accordance with 4.2.3 a); c) At least one clinical manifestation in accordance with 4.2.4 a). 7.1.3 Stage III (AIDS stage) People with HIV infection can be diagnosed if they meet one of the following. a) CD4 T lymphocyte count < 200/mm3; b) At least one clinical manifestation in accordance with 4.2.5 a). 7.1.4 The main conditions of adult and adolescent clinical staging are shown in Table 1.

Appendix A

(Informative appendix) Clinical manifestations of HIV infection A.1 Acute HIV infection syndrome (acute HIV infection syndrome) Fever, sore throat, rash, muscle and joint pain, swollen lymph nodes, headache, diarrhea, nausea, A group of clinical manifestations such as vomiting. A.2 Persistent generalized lymphoadenopthy (PGL) In HIV-infected patients, there are no other causes of swelling of two or more lymph nodes outside the groin, diameter > 1 cm, lasting for more than 3 months. A.3 HIV wasting syndrome People with HIV infection or AIDS have a weight loss of more than 10% within half a year, accompanied by persistent fever for more than 1 month, or persistent diarrhea. Symptoms and signs such as poor appetite, weakness and weakness after 1 month. A.4 HIV associated neurocognitive disorders Abnormalities in perception and motor neurons caused by HIV infection affect daily work, manifesting as forgetfulness, difficulty concentrating, and thinking Slow maintenance, depression, damage to subtle motor function, etc. A.5 HIV-related neurocognitive disorders in children (infant HIV associated neurocognitive disorders) Children infected with HIV have one of the following symptoms for no other reason. - Brain development disorder or atrophy; --Mental retardation; -Symmetrical dyskinesia; - Paresis; - Ataxia or gait disturbance. A.6 Classification of clinical manifestations of HIV infection A.6.1 The clinical manifestations of adults and adolescents over 15 years old (including 15 years old) are divided into group A, group B and group C A.6.1.1 Group A clinical manifestations This group of clinical manifestations occurs when the immune system is mildly defective, and includes any of the following. - Unexplained weight loss, no more than 10% of the original weight; --Recurrent upper respiratory tract infection, ≥2 times in the past 6 months; WS 293-2019 --Shingles; --Angular cheilitis and cheilitis; --Recurrent oral ulcers, ≥2 times in the past 6 months; --Prurigo nodosa; --Seborrheic dermatitis; -Onychomycosis. A.6.1.2 Group B clinical manifestations This group of clinical manifestations occurs when the immune system is moderately defective and includes any of the following. - Unexplained weight loss, more than 10% of the original weight; -Unexplained diarrhea, lasting more than 1 month; -Unexplained fever, intermittent or continuous for more than 1 month; --Persistent oral Candida infection; - Hairy leukoplakia of oral mucosa --Pulmonary tuberculosis (current disease); --Severe bacterial infections (such as pneumonia, body cavity or visceral abscess, purulent myositis, bone and joint infections, meningitis, bacteremia); --Acute necrotizing ulcerative gingivitis, periodontitis or stomatitis; --Unexplained anemia (hemoglobin < 80 g/L) and neutropenia (neutrophil count < 0.5×109/L) or platelets Decrease (platelet count < 50×109/L), lasting more than 1 month. A.6.1.3 Group C clinical manifestations The clinical manifestations of this group appear when the immune system is severely defective and are indicative of AIDS, including any of the following. --HIV wasting syndrome; --Pneumocystis pneumonia; -Esophageal Candida infection; -Disseminated fungal disease (coccidioidomycosis or histoplasmosis); --Recurrent bacterial pneumonia, ≥2 times in the past 6 months; - Chronic herpes simplex virus infection (lip, genital or anorectal) more than 1 month; - Any internal organs herpes simplex virus infection; -Cytomegalovirus infectious diseases (except liver, spleen, and lymph nodes); --Extrapulmonary tuberculosis; - Disseminated non-tuberculous mycobacterial disease; --Recurring non-typhoid Salmonella sepsis; --Chronic cryptosporidiosis (with diarrhea, lasting > 1 month); --Chronic isosporosis; --Atypical disseminated leishmaniasis; -Kaposi's sarcoma; -Brain or B-cell non-Hodgkin's lymphoma; --Invasive cervical cancer; --Toxoplasma encephalopathy; -Penicillium Marneffei; --Pulmonary cryptococcosis, including cryptococcal meningitis; WS 293-2019 --Progressive multifocal leukoencephalopathy; --HIV-related neurocognitive disorders; - Symptomatic HIV-related cardiomyopathy or nephropathy. A.6.2 The clinical manifestations of children under 15 years of age are divided into groups D, E and F A.6.2.1 Group D clinical manifestations This group of clinical manifestations occurs when the immune system is mildly defective, and includes any of the following. --Unexplained hepatosplenomegaly; --Prurigo nodosa; --Recurrent or persistent upper respiratory tract infection; --Shingles; - Extensive wart virus infection; - Extensive molluscum contagiosum infection; --Linear gingival erythema; --Angular cheilitis and cheilitis; --Recurrent oral ulcers; --Unexplained persistent parotid gland enlargement; -Onychomycosis. A.6.2.2 Group E clinical manifestations This group of clinical manifestations occurs when the immune system is moderately defective and includes any of the following. -Unexplained moderate malnutrition; --Unexplained persistent diarrhea; - Unexplained fever ( >37.5 ℃), repeated or lasting for more than 1 month; -Oropharyngeal Candida infection (except within 6-8 weeks of birth); - Hairy leukoplakia of oral mucosa --Acute necrotizing ulcerative gingivitis, periodontitis or stomatitis; --Lymph node tuberculosis; --Pulmonary tuberculosis; --Recurrent severe bacterial pneumonia; --Symptomatic lymphoid interstitial pneumonia; --Chronic HIV-related lung diseases, including bronchiectasis; --Unexplained anemia (hemoglobin < 80 g/L) and neutropenia (neutrophil count < 0.5×109/L) and (or) slow Thrombocytopenia (platelet count < 50×109/L). A.6.2.3 Group F clinical manifestations The clinical manifestations of this group appear when the immune system is severely defective and are indicative of AIDS, including any of the following. - Unexplained severe weight loss, growth or malnutrition; --Pneumocystis pneumonia; -Candida infection of the esophagus, trachea, bronchus or lung; -Disseminated fungal disease (histoplasmosis or coccidioidomycosis); WS 293-2019 --Recurrent severe bacterial infections, such as meningitis, bone or joint infections, body cavity or internal organ abscesses, purulent myositis (lung Except inflammation); --Extrapulmonary tuberculosis; - Disseminated nontuberculous mycobacterial infection; --Chronic herpes simplex virus infection (lip or skin), lasting for more than 1 month; - Any internal organs herpes simplex virus infection; - Cytomegalovirus infection, including retinitis and infection of other organs (except neonatal period); --Chronic cryptosporidiosis (with diarrhea); --Chronic isosporosis; --Symptomatic HIV-related cardiomyopathy or nephropathy; -Kaposi's sarcoma; -Brain or B-cell non-Hodgkin's lymphoma; --Toxoplasma encephalopathy (except for neonatal period); -Penicillium Marneffei; --Pulmonary cryptococcosis, including cryptococcal meningitis; --Progressive multifocal leukoencephalopathy; --HIV-related neurocognitive disorders.

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