Chlamydia Diagnostic Test Kit for Swab/Urine Samples Professional Grade
|
Detailed Product Description
|
Chlamydia Rapid Test (Swab/Urine)
【INTENDED USE】 The Chlamydia Rapid Test (Swab/Urine) is a rapid visual immunoassay
for the qualitative presumptive detection of Chlamydia trachomatis
in female cervical swab, male urethral swab and male urine
specimens. This kit is intended for use as an aid in the diagnosis
of Chlamydia infection.
【INTRODUCTION】 The genus Chlamydia includes three species: Chlamydia trachomatis,
the recently described Chlamydia pneumoniae, primarily associated
with humans, and Chlamydia psittasi, primarily associated with
animals. Chlamydia trachomatis comprises 15 known serovars, is
associated with trachomatis and gentourinary infection, and three
serovars are associated with lymphogranuloma venereum (LGV).
Chlamydia trachomatis infections are the most common bacterial
sexually transmitted diseases. Approximately 4 million new cases
occur each year in the United States, primarily cervicitis and
nongonococcal urethritis. This organism also causes conjunctivitis
and infant pneumonia. Chlamydia trachomatis infection has both a
high prevalence and asymptomatic carriage rate, with frequent
serious complications in both women and neonates. Complications of
chlamydia infection in women include cervictis, urethritis,
endometritis, pelvic inflammatory diseases (PID) and increased
incidence of ectopic pregnancy and infertility. Vertical
transmission of the disease during parturition from mother to
neonate can result in inclusion conjunctivitis and pneumonia. In
men, at least 40% of cases of nongonococcal urethritis are
associated with chlamydia infection and epididymitis. Approximately
70% of women with endocervical infections and up to 50% of men with
urethral infections are symptomatic. Chlamydia psittasi infection is associated with respiratory disease
in individuals exposed to infected birds and is not transmitted
from human to human. Chlamydia pneumonia, first isolated in 1983,
is associated with respiratory infections and pneumonia.
Traditionally, chlamydia infection has been diagnosed by the
detection of chlamydia inclusions in tissue culture cells. Culture
method is the most sensitive and specific laboratory method, but it
is labour intensive, expensive, lengthy (2-3 days) and not
routinely available in most institutions. Direct tests such as
immunofluorescence assay (IFA) require specialized equipment and a
skilled operator to read the result.
【PRINCIPLE】 The Chlamydia Rapid Test detects Chlamydia trachomatis through
visual interpretation of color development on the internal strip.
Antigen-specific lipopolysaccharide (LPS) monoclonal antibody is
immobilized on the test region of the membrane. During testing, the
specimen reacts with monoclonal anti-Chlamydia antibodies
conjugated to colored particles and precoated onto the sample pad
of the test. The mixture then migrates through the membrane by
capillary action and interacts with reagents on the membrane. If
there is sufficient chlamydia antigen in the specimen, a colored
band will form at the test region of the membrane. The presence of
this colored band indicates a positive result, while its absence
indicates a negative result. The appearance of a colored band at
the control region serves as a procedural control, indicating that
the proper volume of specimen has been added and membrane wicking
has occurred.
【MAIN CONTENTS】 • One pouch containing a rapid test cassette with desiccant. • Reagent 1 • Reagent 2 • Swab • Extraction Tube with tip • Package insert 【PRECAUTIONS】 • For professional in vitro diagnostic use only. • Do not use after the expiration date indicated on the package. Do
not use the test if the foil pouch is damaged. Do not reuse tests. • This kit contains products of animal origin. Certified knowledge
of the origin and/or sanitary state of the animals does not
completely guarantee the absence of transmissible pathogenic
agents. It is therefore recommended that these products be treated
as potentially infectious, and handled by observing usual safety
precautions (e.g., do not ingest or inhale). • Avoid cross-contamination of specimens by using a new extraction
tube for each specimen obtained. • Read the entire procedure carefully prior to testing. • Do not eat, drink or smoke in any area where specimens and kits
are handled. Handle all specimens as if they contain infectious
agents. Observe established precautions against microbiological
hazards throughout the procedure and follow standard procedures for
the proper disposal of specimens. Wear protective clothing such as
laboratory coats, disposable gloves and eye protection when
specimens are assayed. • Do not interchange or mix reagents from different lots. Do not
mix solution bottle caps. • Humidity and temperature can adversely affect results. • When the assay procedure is complete, dispose of swabs carefully
after autoclaving them at 121°C for at least 20 minutes.
Alternatively, swabs can be treated with 0.5% sodium hypochlorite
(i.e., household bleach) for one hour before disposal. • Used testing materials should be discarded according to local
regulations. • Do not use cytology brushes with pregnant patients.
【STORAGE AND STABILITY】 • Store at 2 ~ 30 º C in the sealed pouch for 24 months. • Keep away from direct sunlight, moisture and heat. • DO NOT FREEZE. • Care should be taken to protect the components of this kit from
contamination. Do not use if there is evidence of microbial
contamination or precipitation. Biological contamination of
dispensing equipments, containers or reagents can lead to false
results.
【SAMPLE COLLECTION】 • The quality of specimen obtained is of extreme importance.
Detection of chlamydia requires a vigorous and thorough collection
technique which provides cellular material rather than just body fluids. Do not use 0.9% sodium chloride to treat swabs before collecting
specimens. For female cervical specimens: • Use the swab provided with the kit. • Before specimen collection, remove excess mucus from the
endocervical area with a separate swab or cotton ball and discard.
The swab should be inserted into the endocervical canal, past the
squamocolumnar junction, until most of the tip is no longer
visible. This will permit acquisition of columnar or cuboidal
epithelial cells which are the main reservoir of chlamydia
organisms. Firmly rotate the swab for 15 - 20 seconds without
contamination with exocervical or vaginal cells. • If the swab may be tested immediately, replace the swab into the
extraction tube. For male urethral specimens: • Standard wire-shafted fiber-tipped swabs or cytology brushes (not
provided) should be used for urethral specimen collection. Instruct
the patients not to urinate at least one hour prior to specimen
collection. • Insert the swab 2-4 cm into the urea, rotate for 3-5 seconds and
withdraw it. If the swab may be tested immediately, replace the
swab into the extraction tube. For male urine specimens: • Collect 15-30 mL of clean first morning urine in a sterile urine
cup. First morning urine specimens are preferred to achieve the
highest concentrations of Chlamydia antigen. • Mix the urine specimen by inverting the container. Transfer 10 mL
of the urine specimen into a centrifuge tube, add 10 mL distilled
water and centrifuge at 3,000 rpm for 15 minutes. • Carefully discard the supernatant, keep the tube inverted and
remove any supernatant from the rim of tube by blotting onto
absorbent paper. • If the test is to be conducted immediately, treat the urine
pellet according to the Directions for Use. • Do not place the swab in any transport device containing medium.
Transport medium interferes with the assay, and viability of
organisms is not required for the assay. If immediate testing is
not possible, patient samples should be placed in a dry transport
tube for storage or transport. The swabs may be stored for 4 hours
at room temperature (15-30°C) or 24 hours refrigerated (2- 8°C).
The urine specimens can be stored refrigerated (2-8°C) for 24
hours. Do not freeze. All specimens should be allowed to reach a
room temperature of 15- 30°C before testing.
【DIRECTION OF USE】 Allow the test, specimen, reagents, and/or controls to reach room
temperature (15- 30°C) prior to testing. 1. Remove the test cassette from the sealed foil pouch and use it
as soon as possible. Best results will be obtained if the test is
performed immediately after opening the foil pouch. 2. Extract the Chlamydia antigen according to the specimen type. For Female endocervical or Male urethral swab specimens: • Place a clean extraction tube in the workstation. Add 5 drops of
Ragent 1 to the extraction tube. • Immerse the patient swab into the extraction tube and wait 2
minutes. While waiting, use a circular motion to roll the swab
against the side of the extraction tube so that the liquid is
expressed from the swab and can reabsorb. • Add 6 drops of Reagent 2. Squeeze the swab firmly against the
tube to expel as much liquid as possible from the swab for 1
minute. Discard the swab following guidelines for handling
infectious agents. Fit the dropper tip on top of the extraction
tube. • The extracted specimen can remain at room temperature for 60
minutes without affecting the test result. For Male urine specimens: • Add 6 drops of Reagent 2 to the urine pellet in the centrifuge
tube, then draw the liquid up and down with a pipette to vigorously
mix until the suspension is homogeneous. • Transfer all the solution in the centrifuge tube to an extraction
tube. Let stand for 2 minute. Hold the Reagent 2 bottle upright and
add 5 drops of Reagent 1 to the extraction tube. Vortex or tap the
bottom of the tube to mix the solution. Let stand for 1 minutes. • Fit the dropper tip on top of the extraction tube. 3. Add 2 drops (approximately 50 µL) of extracted specimen from the
extraction tube to the specimen well (S) of the test cassette. Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result window. As the test begins to work, color will migrate across the membrane. 4. Wait for the colored band(s) to appear. The result should be
read at 10 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】 POSITIVE: The presence of two lines as control line (C) and test line (T)
within the result window indicates a positive result. NEGATIVE: The presence of only control line (C) within the result window
indicates a negative result. INVALID: If the control line (C) is not visible within the result window
after performing the test, the result is considered invalid. Some
causes of invalid results are because of not following the
directions correctly or the test may have deteriorated beyond the
expiration date. It is recommended that the specimen be re-tested
using a new test. For further operation or performance details, please refer to final instruction manual.
|
| Product Tags: Urine Samples Chlamydia Diagnostic Test Kit Swab Chlamydia Diagnostic Test Kit Professional Grade Chlamydia Diagnostic Test Kit |
Related Products
|
First Response HIV 1+2/Syphilis Combo Card Test in Human Serum, Plasma or Whole Blood |
|
Dewei Hepatitis E Virus IgM Antibody Check HEV Rapid Test Cassette |
|
One Step CHW Test Canine Heartworm Antigen Rapid Diagnostic Kit 10 Test Box |
|
Cost Effective Giardia Lamblia Antigen (GIA)Rapid Test in Human Feces |
|
CE Vibrio Cholerae Rapid Test Kit O1/O139 Stool Detection Qualitative Rapid Test |
|
Rapid HCG Pregnancy Urine Test Dipstick Strip Pen CE ISO13485 NMPA Approved |
Email to this supplier