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WS 273-2018: Diagnosis for syphilis
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PDF similar to WS 273-2018
Basic data | Standard 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Count Estimation | 22,222 | | Date of Issue | 2018-03-06 | | Date of Implementation | 2018-08-01 | | Older Standard (superseded by this standard) | WS 273-2007 | | Regulation (derived from) | State-Health-Communication (2018) 4 | | Issuing agency(ies) | National Health Commission | WS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
Foreword
Chapter 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 diagnosis
1 Scope
This 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 definitions
The 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 Abbreviations
The 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 laboratory
4 diagnosis basis
4.1 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 principles
A comprehensive analysis should be performed based on epidemiological history, clinical manifestations, and laboratory tests to make a diagnosis.
6 diagnosis
6.1 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 diagnosis
7.1 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.
A.1.5 Results and explanation
A.1.5.1 Under the dark field microscope, the typical syphilis spirochete is white-emitting, and its spiral is dense and uniform, with an average of 8 to 14. Sports regulations
Law, strong exercise, observe the form of exercise to help distinguish with other spirals. Seeing Treponema pallidum, combined with typical clinical manifestations,
Have the value of confirming syphilis. Its movements include the following.
a) Rotating, rotating around its long axis;
b) Snake-like, full-body bending like a snake;
c) Move and retract the distance between the spirals.
A.1.5.2 Undetected spirochetes cannot exclude the diagnosis of syphilis, and negative results may indicate.
a) insufficient number of spirochetes (single dark field microscopy with a sensitivity of less than 50%);
b) the patient has received antibiotics or medication to kill Treponema pallidum;
c) Damage is close to natural regression.
A.2 Tremella spiral staining check
A.2.1 Principle
Treponema pallidum is silver-brown and can be dyed brownish black by silver solution. Treponema pallidum can be observed under ordinary microscope.
A.2.2 Materials
Ordinary optical microscope, blunt knife (scrape), Canadian gum, Roger's fixative, tannic mordant, Fontana silver solution, none
Water alcohol.
A.2.3 Drawing
Same as A.1.3.
A.2.4 Method
A.2.4.1 Smear drying. The specimen is applied to a clean glass slide and sliced and dried naturally in the air (not allowed to be dried by fire).
A.2.4.2 Fixation. Fix the smear with Rogge's fixative for 2 min to 3 min.
A.2.4.3 Washing. Wash the oil on the slide with absolute alcohol.
A.2.4.4 mordant. Add 2~3 drops of bismuth mordant to the smear, slightly heat to produce steam, dye for 30s.
A.2.4.5 Silver staining. Wash with water, add Fontana silver solution on the smear, slightly heat to produce steam, dye for 30s.
A.2.4.6 Microscopic examination. Washed, dried, covered with a glass slide, sealed with Canadian gum (the purpose of sealing is to prevent the use of mirror oil, make specimens
Decolorization, while conducive to long-term preservation), with oil mirror inspection.
A.2.5 Results and explanation
A.2.5.1 Observation under the microscope. Treponema pallidum is dyed brown.
A.2.5.2 Interpretation of clinical significance with dark field microscopy. When the specimen is positive, if there is typical skin mucosal damage, it can be diagnosed.
If the specimen is negative, syphilis cannot be completely excluded and should be reviewed if necessary. Attention should be paid to the identification of saprophytic spirochetes.
A.3 Treponema pallidum nucleic acid amplification test
A.3.1 Principle
A polymerase chain reaction (PCR) method was employed. Through specific primers and thermal cycling reactions under specific conditions, the tissue fluid in the lesion site, drenched
Treponema pallidum in samples of puncture fluid and cerebrospinal fluid for nucleic acid detection, in the diagnosis of early syphilis, neurosyphilis and congenital syphilis
Have a certain value.
A.3.2 Materials
A.3.2.1 PCR primers. Treponema pallidum nucleic acid amplification detection generally uses primers such as bmp, tpp47, polA and other gene sequences.
A.3.2.2 Main reagents. including reagents required for nucleic acid extraction and purification and PCR.
A.3.3 Drawing
Same as A.1.3.
A.3.4 Method
A.3.4.1 Nucleic acid extraction. Silica gel column centrifugation, magnetic silica gel particle separation, etc., and commercial kits are operated according to the instructions.
Perform nucleic acid extraction.
A.3.4.2 PCR amplification reaction. PCR amplification reaction system includes four kinds of deoxynucleotides, PCR buffer, Taq DNA polymerase, primers (sets)
The PCR includes an internal primer and an external primer), and the corresponding program is used for amplification according to different detection purposes.
A.3.4.3 Analysis of amplification products. At present, fluorescence quantitative analysis methods are commonly used.
A.3.5 Results and explanation
A.3.5.1 Each test needs to be a positive control and a negative control at the same time. Only the positive control amplifies the expected fragment, and the negative control does not.
Amplification of any fragment is considered experimental and can be used to determine the positive or negative result of the nucleic acid test.
A.3.5.2 Clinical significance is the same as dark field microscopy, but the sensitivity of PCR is higher than that of dark field microscopy.
A.4 syphilis serological examination
A.4.1 Meaning and classification
When the human is infected with Treponema pallidum 4 weeks to 10 weeks, a certain amount of non-specific antibodies against lipid-like antigens can be produced in the serum (reverse
Specific antibodies to anti- Treponema pallidum antigens. These antibodies can all be detected by immunological methods. Serological examination is a supplementary diagnosis
An important means of breaking syphilis.
According to the different antigens used in the test, the syphilis serological tests are divided into two categories. one is a non-treponema pallidum serological test (also known as syphilis)
Non-specific antibody test), mainly including VDRL, RPR, TRUST, etc.; the other is syphilis serological test (also known as syphili...
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