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Basic dataStandard ID: WS 273-2018 (WS273-2018)Description (Translated English): Diagnosis for syphilis Sector / Industry: Health Industry Standard Classification of Chinese Standard: C59 Word Count Estimation: 22,222 Date of Issue: 2018-03-06 Date of Implementation: 2018-08-01 Older Standard (superseded by this standard): WS 273-2007 Regulation (derived from): State-Health-Communication (2018) 4 Issuing agency(ies): National Health Commission WS 273-2018: Diagnosis for syphilis---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 syphilis ICS 11.020 C 59 WS People's Republic of China Health Industry Standard Replacing WS 273-2007 Syphilis diagnosis Published on.2018-03-06 2018-08-01 implementation National Health and Family Planning Commission of the People's Republic of China ForewordChapter 6 of this standard is 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 273-2007 "Syphilis Diagnostic Criteria". Compared with WS 273-2007, the main technical changes of this standard are as follows. - increased the definition of syphilis serum fixation (see 2.3); -- Increased silver staining of Treponema pallidum (see A.2), Treponema pallidum nucleic acid amplification assay (see A.3), Treponema pallidum Rapid test (see A.4.3.5), Treponema pallidum chemiluminescence immunoassay (see A.4.3.6), Treponema pallidum IgM Antibody detection (see A.4.3.8); - Revised the description of the epidemiological history and clinical manifestations of latent syphilis (see 5.4.1 and 5.4.2, 4.4.1 and 4.4.2 of the.2007 edition); -- Revised the diagnostic requirements for suspected cases of syphilis, secondary syphilis, tertiary syphilis, and latent syphilis (see 6.1.1, 6.2.1, 6.3.1) 6.4.1, 6.1.1, 6..2.1, 6.3.1, 6.4.1) of the.2007 edition; -- Revised the diagnostic requirements for fetal syphilis (see 6.5.1 and 6.5.2,.2007 editions 6.5.1 and 6.5.2). This standard was drafted. Dermatology Hospital (Institute of Chinese Academy of Medical Sciences), General Hospital of Tianjin Medical University, and affiliated to Fudan University Shan Hospital, Southern Medical University Dermatology Hospital (Guangdong Province Dermatology Hospital), Peking Union Medical College Hospital. The main drafters of this standard. Wang Qianqiu, Liu Quanzhong, Xu Jinhua, Chen Xiangsheng, Yin Yueping, Gong Xiangdong, Su Xiaohong, Zeng Xuesi, Yang Li Gang, Zheng Heyi. The previous versions of the standards replaced by this standard are. --GB 15974-1995; --WS 273-2007. Syphilis diagnosis1 ScopeThis standard specifies the diagnostic basis, diagnostic principles, diagnosis and differential diagnosis of syphilis. This standard is applicable to the diagnosis of syphilis by various medical and health institutions at all levels and their medical staff.2 Terms and definitionsThe following terms and definitions apply to this document. 2.1 Syphilis syphilis Treponema pallidum subp. pallidum (also known as Treponema pallidum) infects human body A systemic, chronic sexually transmitted disease that can cause damage to multiple organs and multiple organs in the human body, resulting in a variety of clinical manifestations, leading to tissue breakage Bad, dysfunctional, and even life-threatening. 2.2 Prozone phenomenon In non-treponema pallidum serological tests (such as RPR test), because the serum antibody level is too high, the proportion of antigen-antibody is inappropriate, and A false negative or weak positive result occurs, and the serum is diluted and then serologically tested. A positive result is called a prozone phenomenon. this phenomenon Clinically, it mainly occurs in patients with secondary syphilis. 2.3 Syphilis serum fixed syphilis serofast Patients with syphilis were treated with standardized anti-syphilis treatment and follow-up for a certain period of time (one-year syphilis follow-up for 1 year, secondary syphilis followed for 2 years, late plum) The venom serological test was maintained at a certain titer (usually 1.8 or below, but not more than 1.8). Exclusion of reinfection, neurosyphilis, cardiovascular syphilis and biological false positives, ie syphilis serum fixation.3 AbbreviationsThe following abbreviations apply to this document. CLIA. chemiluminescence immunoassay ELISA. enzyme-linked immunosorbent assay FTA-ABS. fluorescent treponemal antibody-absorption PCR. polymerase chain reaction RPR. rapid plasma reaxin ring test (rapid plasma reagin) RT. rapid test (rapid test) TPHA. Treponema pallidum hemagglutination assay TPPA. Treponema pallidum particle agglutination TRUST. toluidine red unheated serum test VDRL. Venexeal disease research laboratory4 diagnosis basis4.1 Primary syphilis 4.1.1 History of epidemiology Most have a history of unsafe sex, or a history of sexual partner infection, or a history of multiple sexual partners. 4.1.2 Clinical manifestations Hard squat. The incubation period is 2 weeks to 4 weeks (average 3 weeks), which is more common in sexual contact sites such as the external genitalia. Initially manifested as a small pimples, gradually Developed into a round or oval shallow ulcer with a diameter of about 1cm ~ 2cm, the boundary is clear, the edge is slightly raised, the ulcer surface is clean; generally a single hair; The palpation base was tough and cartilage-like; there was no obvious pain or tenderness. Hard squats can also be atypical, or because of secondary bacterial infections, performance It is conscious pain, multiple ulcers, deep or large ulcers, purulent exudate on the ulcer surface, and hard to touch. Swollen lymph nodes in the groin or affected area. can be unilateral or bilateral, painless, isolated from each other without adhesion, hard, no pus, The surface of the skin has no redness and fever. 4.1.3 Laboratory inspection 4.1.3.1 Dark field microscopy, silver staining test or nucleic acid amplification test Hard chancreous lesions can be found in effusion or lymph node puncture fluid, and treponema pallidum can be detected by nucleic acid amplification test. (See Appendix A.1, A.2, A.3). 4.1.3.2 Non-tremplasmic spirochete serological test Positive (see A.4.2). If the infection is less than 6 weeks, the test can be negative and should be reviewed after 6 weeks of infection. 4.1.3.3. Treponema pallidum serological test Positive (see A.4.3). If the infection is less than 4 weeks, the test may also be negative and should be reviewed 4 weeks after infection. 4.2 secondary syphilis 4.2.1 History of epidemiology Most have a history of unsafe sexual behavior, or a history of sexual partner infection, or a history of multiple sexual partners; or a history of blood transfusion (the donor is an early syphilis patient). can There is a history of syphilis, the disease period is less than 2 years. 4.2.2 Clinical manifestations Skin lesions. pleomorphic, can simulate a variety of skin lesions, including macules, maculopapular rash, papules, papules scaly rash and pustular rash, often Generalized symmetry; dark erythema and desquamative rash on the palmar palpebral; wet papules and flattened genital warts in the vulva and perianal; skin lesions are generally non-conscious It may also have itching; mucous membrane spots may occur in the mouth, or mucosal plaques may be present in the genital area; worm-like hair loss may occur. Second stage recurrent syphilis, Skin lesions are limited, the number is small, the shape is singular, often ring-shaped, arched or curved. The superficial lymph nodes of the whole body can be swollen. There may be syphilitic bone and joint damage, eye damage, nervous system and other visceral damage. 4.2.3 Laboratory inspection 4.2.3.1 Dark field microscopy, silver staining test or nucleic acid amplification test Secondary syphilis skin lesions such as flat wet phlegm, wet papules and mucosal plaques, which can be found in septic spirulina, or nucleic acid amplification test Treponema pallidum nucleic acid is positive (see A.1, A.2, A.3). 4.2.3.2 Non-tremplasmic spirochete serological test Positive (see A.4.2). 4.2.3.3 Treponema pallidum serological test Positive (see A.4.3). 4.3 Phase III syphilis 4.3.1 History of epidemiology Most have a history of unsafe sex, or a history of sexual partner infection, or a history of multiple sexual partners. There may be a history of syphilis in one or two phases. The disease period is more than 2 years. 4.3.2 Clinical manifestations Late benign syphilis. skin mucosal damage manifested as nodular syphilis on the head and face and extremities, near joint nodules near the large joint, Skin, mouth, gut pharyngeal gums, gums of the upper jaw and nasal septum mucosa can cause perforation of the upper jaw and nasal septum and saddle nose. Bone plum can also occur Toxic and other visceral syphilis, involving bones and joints, respiratory tract, digestive tract, liver and spleen, genitourinary system and endocrine glands. Eye syphilis. a small number of iridocyclitis, retinitis and interstitial keratitis can occur, which can cause blindness. Neurosyphilis. meningeal neurosyphilis (headache, vomiting, neck stiffness, etc.), meningeal vascular syphilis (occlusion of the occlusion brain) Vascular syndrome manifests as hemiplegia, aphasia, epileptic seizures, brain parenchymal syphilis (paralytic dementia, spinal cord spasm, etc.), or no Symptomatic neurosyphilis, only abnormalities found in cerebrospinal fluid. Cardiovascular syphilis. simple aortitis, aortic insufficiency, aortic aneurysm, etc. may occur. 4.3.3 Laboratory inspection 4.3.3.1 Non-tremplasmic spirochete serological test Positive (see A.4.2). 4.3.3.2 Treponema pallidum serological test Positive (see A.4.3). 4.3.3.3 Cerebrospinal fluid examination (mainly used for the diagnosis of neurosyphilis) The white blood cell count is ≥10×10 6 /L, the protein amount is >500 mg/L, and there are no other causes of these abnormalities. Cerebrospinal fluid VDRL test (or RPR/T RUST test) or FTA-ABS test (or TPPA/T PHA test) is positive (see A.4.2, A.4.3). 4.3.3.4 Histopathological examination There are three histopathological changes in syphilis (see A.5). 4.4 recessive syphilis (latent syphilis) 4.4.1 History of epidemiology Most have a history of unsafe sex, or a history of sexual partner infection, or a history of multiple sexual partners. Early recessive syphilis. In the past 2 years, the following situations have been made. a) have a clear history of unsafe sex, and no history of unsafe sex two years ago; b) had clinical manifestations consistent with stage I or II syphilis, but did not receive diagnosis and treatment at that time; c) Sex accompanied by a clear history of early syphilis infection. Late recessive syphilis. The infection time is more than 2 years. Those who cannot judge the time of infection are also considered to be late recessive syphilis. There is no clear history of diagnosis or treatment of syphilis. 4.4.2 Clinical manifestations No clinical manifestations of syphilis. 4.4.3 Laboratory inspection 4.4.3.1 Non-tremplasmic spirochete serological test Positive (see A.4.2). 4.4.3.2 Treponema pallidum serological test Positive (see A.4.3). 4.4.3.3 Cerebrospinal fluid examination Cerebrospinal fluid examination can be performed to rule out asymptomatic neurosyphilis. There is no obvious abnormality in recessive syphilis. 4.5 fetal syphilis (congenital syphilis) 4.5.1 Epidemiological history The mother is a patient with syphilis. 4.5.2 Clinical manifestations Early fetal syphilis. within 2 years of age, similar to acquired secondary syphilis. Dysplasia; lesions are often blisters - bullae, erythema, mound Rash, flat wet warts; cleft palate in the perioral and perianal areas, radial scars left behind; syphilitic rhinitis and laryngitis; osteomyelitis, osteochondritis and Periostitis; may have systemic lymphadenopathy, hepatosplenomegaly, anemia, etc. Late fetal syphilis. after 2 years of age, similar to acquired third-stage syphilis. Inflammatory damage (interstitial keratitis, neuropathy) Deafness, nose or eucalyptus gelatin, Kleton joints, etc.) or landmark damage (forecrost convex, saddle nose, sabre sputum, lock thoracic joint hypertrophy, Heron teeth, radial cracks around the mouth, etc.). Recessive fetal transmission of syphilis. that is, fetal syphilis is untreated, no clinical symptoms, syphilis serological test is positive, cerebrospinal fluid examination is normal, age < 2 years old for early recessive fetus transmission syphilis, > 2 years old for late recessive fetus transmission syphilis. 4.5.3 Laboratory inspection 4.5.3.1 Dark field microscopy, silver staining test or nucleic acid amplification test Treponema pallidum can be found in skin mucosal lesions or tissue specimens of early fetal syphilis, or syphilis spirals can be detected by nucleic acid amplification test Positive for nucleic acids (see A.1, A.2, A.3). 4.5.3.2 Syphilis serological test The syphilis serological test is as follows. - Non-treponema pallidum serological test at birth, titer greater than or equal to 4 times the mother's pre-delivery titer, and Treponema pallidum Positive serological test (see A.4.2); - Treponema pallidum IgM antibody detection. positive (see A.4.3.8); -- Children who are unable to diagnose fetal syphilis at birth, during any follow-up, the non-treponema pallidum serological test is converted from yin to yang, or The titer is increased and the serological test for Treponema pallidum is positive (see A.4.2); -- Children who were unable to diagnose fetal syphilis before 18 months of age were still positive for serological tests of Treponema pallidum after 18 months of age (see A.4.3).5 Diagnostic principlesA comprehensive analysis should be performed based on epidemiological history, clinical manifestations, and laboratory tests to make a diagnosis.6 diagnosis6.1 Phase I syphilis 6.1.1 Suspected cases It shall comply with 4.1.1 and 4.1.2 at the same time and shall comply with one of 4.1.3.2 or 4.1.3.3. 6.1.2 confirmed cases It shall comply with 6.1.1 and 4.1.3.1, or both 4.1.1, 4.1.2, 4.1.3.2 and 4.1.3.3. 6.2 secondary syphilis 6.2.1 Suspected cases It shall comply with 4.2.1 and 4.2.2 at the same time and shall comply with one of 4.2.3.2 or 4.2.3.3. 6.2.2 confirmed cases It shall comply with 6.2.1 and 4.2.3.1 at the same time, or at the same time comply with 4.2.1, 4.2.2, 4.2.3.2 and 4.2.3.3. 6.3 Phase III syphilis 6.3.1 Suspected cases It shall comply with 4.3.1 and 4.3.2 at the same time and shall comply with one of 4.3.3.1 or 4.3.3.2. 6.3.2 confirmed cases It shall comply with 4.3.1, 4.3.2 and 4.3.3.1 at the same time and shall comply with one of 4.3.3.2 or 4.3.3.4. Diagnosis of neurosyphilis should also be Conforms to 4.3.3.3. 6.4 recessive syphilis (latent syphilis) 6.4.1 Suspected cases It shall comply with 4.4.1 and 4.4.2 at the same time and shall comply with one of 4.4.3.1 or 4.4.3.2. 6.4.2 confirmed cases It should also comply with 4.4.1, 4.4.2, 4.4.3.1, 4.4.3.2 and 4.4.3.3. 6.5 fetal syphilis (congenital syphilis) 6.5.1 Suspected cases All infants born to syphilis mothers who have not been effectively treated have insufficient evidence to confirm the diagnosis of fetal syphilis. 6.5.2 confirmed cases It shall comply with 4.5.1 and 4.5.2 at the same time and shall comply with one of 4.5.3.7 differential diagnosis7.1 Phase I Syphilis 7.1.1 Hard squat Need to be with soft chancre, genital herpes, sexually transmitted lymphogranuloma, erosive balanitis, Behcet's disease, fixed drug eruption, cancer, skin Tuberculosis, etc. occur in the genital area of erythema, erosion and ulcer identification. 7.1.2 syphilitic inguinal lymphadenopathy Need to be differentiated from inguinal lymphadenopathy caused by soft chancre, sexually ill lymphogranuloma, and metastatic cancer. 7.2 secondary syphilis 7.2.1 syphilitic macule Need to be with pityriasis rosea, psoriasis, lichen planus, hand, foot and ringworm, vitiligo, tinea versicolor, drug eruption, polymorphous erythema, telecentric annular erythema Identification. 7.2.2 syphilitic papules and flat wet sputum It needs to be differentiated from psoriasis, body lice, lichen planus, red pityriasis, and condyloma acuminata. 7.2.3 syphilitic pustules Need to be identified with a variety of impetigo, impetigo, acne, yaw, polymeric acne. 7.2.4 mucosal syphilis Need to be differentiated from infectious mononucleosis, map tongue, thrush, lichen planus, suppurative tonsillitis. 7.2.5 syphilitic hair loss Need to be identified with alopecia areata. 7.3 Phase III syphilis 7.3.1 Nodular syphilis Need to be differentiated from lupus, sarcoidosis, and leprosy. 7.3.2 Glue Need to be differentiated from lupus, leprosy, hard erythema, nodular erythema, panniculitis, cancer. 7.3.3 Neurosyphilis Meningeal neurosyphilis needs to be differentiated from meningitis caused by various causes. Meningeal vascular syphilis needs to be differentiated from stroke caused by various causes. hemp Deafness dementia needs to be differentiated from various mental disorders, Alzheimer's disease (senile dementia), chronic alcoholism, and seizures. Spinal cord hernia Need to be differentiated from Adie syndrome, diabetic pseudothoracic spinal cord and so on. 7.3.4 Cardiovascular syphilis Syphilitic aortic aneurysms need to be differentiated from aortic sclerosis. Syphilitic coronary artery disease needs to be differentiated from coronary atherosclerosis. Syphilitic master Aortic valve insufficiency needs to be differentiated from aortic valve insufficiency caused by various causes. 7.4 latent syphilis (hidden syphilis) There was no obvious clinical manifestation, but the syphilis serological test was positive and needed to be differentiated from the serum fixation after syphilis treatment.Appendix A(normative appendix) Laboratory examination of syphilis A.1 Treponema pallidum dark field microscopy A.1.1 Principle Dark field microscopy is a special concentrator, divided into dry and wet, with black paint in the center, only in At the periphery of the circle, there is a slanted corner of the light, and the light can only be incident on the slide from the oblique angle of its circumferential edge. Treponema pallidum examination Device. If the oblique light encounters an object on the slide, such as a spiral, the object will illuminate. A.1.2 Materials Dark field microscope, blunt knife (scrape), slide, syringe, injection needle, sterile isotonic saline. A.1.3 Drawing A.1.3.1 Skin mucosal damage. First, add 50 μL to 100 μL of saline on a glass slide (thickness 1.0 mm to 1.2 mm) for use. Then use a cotton swab to remove the dirt from the skin lesions with sterile saline. If there is a suede on the skin lesion, it can be carefully removed with a blunt knife. Gently use a blunt knife Scrape several times (to avoid bleeding), take the tissue exudate and mix it with the saline on the slide, and cover the slide with a dark field microscope. A.1.3.2 Lymph node extraction. Disinfect the surface of the lymph nodes and dry them with a sterile dry cotton ball. Use a 1mL sterile syringe with a 12 gauge needle to draw Sterile isotonic saline 0.25mL ~ 0.5mL, aseptically puncture the lymph nodes and inject saline, and then inhaled into the syringe, repeated 2 to 3 times, Take a small amount of lymph on the slide, cover the slide, and check under a dark field microscope. A.1.4 Method A.1.4.1 Add a drop of glycerol buffer (glycerol and 0.1mol/L phosphoric acid) to the dark field concentrator (this method uses a wet dark field concentrator) Flush (PBS), pH 7.0, prepared at 7.3)]. A.1.4.2 On the slide on the stage, the rising concentrator will make the glycerin buffer contact the slide, first use the 10x objective to make the image clear, then Observed with a 40x objective lens, looking for Treponema pallidum with characteristic morphology and movement. 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