Chlamydia Rapid Test Cassette (Swab/Urine)
REF ICH-502
English
Urine cup (For male urine specimens only)
Positive control
Centrifuge tube (For male urine specimens only)
Negative control
Sterile male urethral swabs
Timer
Method
PCR
Total
Results
Chlamydia
Rapid Test
Cassette
Results
Positive
Negative
Positive
42 4 46
Negative 3 156
159
Total Results
45
160
205
Method
PCR
Total
Results
Chlamydia
Rapid Test
Cassette
Results
Positive
Negative
Positive
50 5 55
Negative 8 115
123
Total Results
58
120
178
Method
PCR
Total
Results
Chlamydia
Rapid Test
Cassette
Results
Positive
Negative
Positive
35 0 35
Negative 2 60
62
Total Results
37
60
97
Acinetobacter calcoaceticus
Pseudomona aeruginosa
Proteus mirabilis
Acinetobacter spp
Neisseria meningitides
Neisseria gonnorhea
Enterococcus faecalis
Salmonella choleraesius
Group B/C Streptococcus
Enterococcus faecium
Candida albicans
Hemophilus influenzae
Staphylococcus aureus
Proteus vulgaris
Branhamella catarrhalis
Klebsiella pneumoniae
Gardnerella vaginalis
Test Cassette
Extraction tube
Extraction reagent 1 (0.2M NaOH)
Sterile female cervical swabs
Extraction reagent 2 (0.2 M HCl)
Workstation
Package insert
Dropper tip
Index of Symbols
Attention, see
instructions for use
Tests per
kit
Authorized
Representative
For in vitro
diagnostic use only
Use by
Do not reuse
Store between 2-30°C
Lot
Number
REF
Catalog #
Do not use if package
is damaged
Number: 145020902
Effective date: 2016-06-22
Chlamydia
Chlamydia
3 Drops of Solution
Positive Negative
Invalid
23
Package Insert
A rapid test for the qualitative detection of Chlamydia antigen in female cervical swab, male urethral
swab and male urine specimens.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Chlamydia Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative
detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine
specimens to aid in the diagnosis of Chlamydia infection.
【SUMMARY】
Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world.
It is composed of elementary bodies (the infectious form) and reticulate or inclusion bodies (the
replicating form). Chlamydia trachomatis 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 cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased
incidence of ectopic pregnancy and infertility.1 Vertical transmission of the disease during parturition from
to neonate can result in inclusion conjunctivitis or pneumonia. In men, complication of Chlamydia
includes urethritis and epididymitis. At least 40% of the nongonococcal urethritis cases are associated
with Chlamydia infection. Approximately 70% of women with endocervical infections and up to 50% of
men with urethral infections are asymptomatic. Traditionally, Chlamydia infection has been diagnosed by
detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and
specific laboratory method, but it is labor intensive, expensive, long (18-72 hours) and not routinely
available in most situations.
The Chlamydia Rapid Test Cassette (Swab/Urine) is a rapid test to qualitatively detect the Chlamydia
antigen from female cervical swab, male urethral swab and male urine specimens.
【PRINCIPLE】
The Chlamydia Rapid Test Cassette (Swab/Urine) is a qualitative, lateral flow immunoassay for the
detection of Chlamydia antigen from female cervical, male urethral and male urine. In the test, antibody
specific to the Chlamydia antigen is coated on the test line region of the test. During testing, the
extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles. The mixture
migrates up to react with the antibody to Chlamydia on the membrane and generates a color line in the
test region. The presence of this colored line in the test line region indicates a positive result, while its
absence indicates a negative result. To serve as a procedural control, a colored line will always appear
in the control line region, indicating that proper volume of specimen has been added and membrane
wicking has occurred.
【REAGENT】
The test contains Chlamydia antibody coated particles and Chlamydia antibodies coated on the
membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only. Do not use after the expiration date.
2. Do not eat, drink or smoke in the area where the specimens and kits are handled.
3. Handle all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow the standard procedures for proper
disposal of specimens.
4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when
specimens are assayed.
5. The used test should be discarded according to local regulations.
6. Humidity and temperature can adversely affect results.
7. Do not use test if pouch is damaged.
【STORAGE AND STABILITY】
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable
through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until
use. DO NOT FREEZE. Do not use beyond the expiration date.
【SPECIMEN COLLECTION AND PREPARATION】
The Chlamydia Rapid Test Cassette (Swab/Urine) can be performed using female cervical swab,
male urethral swab and male urine specimens.
The quality of specimens obtained is of extreme importance. Detection of Chlamydia requires a
vigorous and thorough collection technique that provides cellular material rather than just body fluids.
To collect Female Cervical Swab Specimen:
Use the swab provided in the kit. Alternatively, any plastic-shaft swab may be use.
Before specimen collection, remove excess mucus from the endocervical area with a 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 the Chlamydia organism. Firmly rotate the swab
360°in one direction (clockwise or counterclockwise), let stand for 15 seconds, then withdraw the
swab. Avoid contamination from exocervical or vaginal cells. Do not use 0.9% sodium chloride to
treat swabs before collection specimens.
If the test is to be conducted immediately, put the swab into the extraction tube.
To collect Male Urethral Swab Specimens:
Standard plastic-or wire-shaft sterile swabs should be used for urethral specimen collection.
Instruct patients not to urinate for at least 1 hour period to specimen collection.
Insert the swab into the urethral about 2-4cm, rotate the swab 360°in one direction (clockwise or
counterclockwise), let stand for 10 seconds, then withdraw. Do not use 0.9% sodium chloride to
treat swabs before collection swab.
If the test is to be conducted immediately, put the swab into the extraction tube.
To collect Male Urine Specimens:
Collect 15-30ml 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 container. Transfer 10ml of the urine specimen into a
centrifuge tube, add 10ml 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 the tube by blotting onto absorbent pad.
If the test is to be conducted immediately, treat the urine pellet according to the Directions for Use.
It is recommended that specimens be processed as soon as possible after collection. If
immediately testing is not possible, the patient swab specimens should be placed in a dry transport
tube for storage or transport. The swab may be stored for 4-6 hours at room temperature (15-30℃)
or 24-72 hours refrigerated (2-8℃) for 24 hours. Do not freeze. All specimens should be allow to
reach the room temperature (15-30℃) before testing.
【MATERIALS】
【DIRECTIONS FOR USE】
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30℃)
prior to testing.
1. Remove the test cassette from the seal pouch and use it as soon as possible. Best result 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 Cervical or Male Urethral Swab Specimen:
Hold the reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300ul) to the extraction
tube. Reagent 1 is colorless. Immediately insert the swab, compress the bottom of tube and rotate
swab 15 times. Let stand for 2 minutes.
Hold the reagent 2 bottle vertically add 6 drops of reagent 2 (approx. 250ul) to the extraction tube.
The solution would turn turbid. Compress the bottle of tube and rotate the swab 15 times until the
solution turn clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or
brown. Let stand 1 minute.
Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as
much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.
For Male Urine Specimens:
Hold the reagent 2 bottle vertically and add 6 drops of (approx. 250ul) reagent 2 to the urine pellet
in the centrifuge tube, then shake the tube vigorously until the suspension is homogeneous.
Transfer all the solution in the centrifuge tube to an extraction tube. Let stand for 1 minute. Hold
the reagent 1 bottle upright and add 5 drops of (approx. 300ul) reagent 1 to the extraction tube.
Vertex or tap the bottom of the tube to mix the solution. Let stand for 2 minutes.
Fit the dropper tip on top of the extraction tube.
3. Place the test cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx.
100ul) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the
specimen well.
4. Wait for the color to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another
apparent colored line should be in the test line region (T). A positive result indicates that Chlamydia was
detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of
Chlamydia present in the specimen. Therefore, any shade of color in the test line region (T) should be
considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line
region (T). A negative result indicates that Chlamydia antigen is not present in the specimen, or is
present below the detectable level of the test.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the procedure and repeat the test with a new
test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
【QUALITY CONTROL】
A procedural control is included in the test. A colored line appearing in the control line region (C) is
considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane
wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative
controls be tested as good laboratory practice to confirm the test procedure and to verify proper test
performance.
【LIMITATIONS】
1. The Chlamydia Rapid Test Cassette (Swab/Urine) is for in vitro diagnostic use only. This test should
be used for the detection of Chlamydia antigen from female cervical swab, male urethral swab and
male urine specimens. Neither the quantitative value nor the rate of increase in Chlamydia antigen
concentration can be determined by this qualitative test.
2. This test will only indicate the presence of Chlamydia antigen in specimens from both viable and nonviable Chlamydia. Performance with specimens other than female cervical swabs, male urethral
swabs and male urine has not been assessed.
3. Detection of Chlamydia is dependent on the number of organisms present in the specimen. This can
be affected by specimen collection methods and patient factors such as age, history of Sexually
Transmitted Diseases (STDs), presence of symptoms, etc. The minimum detection level of this test
may vary according to serovar. Therefore, the test results should be interpreted in conjunction with
other laboratory and clinical data available to the physician.
4. Therapeutic failure or success cannot be determined as antigen may persist following appropriate
antimicrobial therapy.
5. Excessive blood on the swab may cause false positive results.
Materials Provided
Materials Required But Not Provided
(Please refer to the illustration above)
【EXPECTED VALUES】
For women attending STD clinics and other high-risk populations, the prevalence of Chlamydia infection
has been repeated to between 20% and 30%. In a low-risk population such as those patients attending
obstetrics and gynecology clinics, the prevalence is approximately 5% or less.
Reports show that for men attending STD clinics, the prevalence of Chlamydia infection is approximately
8% in asymptomatic men and 11% in symptomatic men.
asymptomatic men are less than 5%.3
【PERFORMANCE CHARACTERISTICS】
The Chlamydia Rapid Test Cassette (Swab/Urine) has been evaluated with specimens obtained from
patients of STD clinics. PCR is used as the reference method for the Chlamydia Rapid Test Cassette
(Swab/Urine). Specimens were considered positive if PCR indicated a positive result. Specimens were
considered negative if PCR indicated a negative result. The results show that Chlamydia Rapid Test
Cassette (Swab/Urine) has a high sensitivity relative to PCR.
The Chlamydia Rapid Test Cassette (Swab/Urine) uses an antibody that is highly specific for Chlamydia
antigen in female cervical swab, male urethral swab and male urine specimens. The results show that
the Chlamydia Rapid Test Cassette (Swab/Urine) has a high specificity relative to PCR.
Relative Sensitivity: 93.3% (81.7%-98.6%)* Relative Specificity: 97.5% (93.7%-99.3%)*
Relative accuracy: 96.6% (93.1%-98.6%)* *95% Confidence Intervals
Relative Sensitivity: 86.2% (74.6%-93.9%)* Relative Specificity: 95.8% (90.5%-98.6%)*
Relative accuracy: 92.7% (87.8%-96.1%)* *95% Confidence Intervals
Relative Sensitivity: 94.6% (81.8%-99.3%)* Relative Sensitivity: >99.9% (95.1%-100%)*
Relative Accuracy: 97.9% (92.7%-99.7%)* *95% Confidence Intervals
The antibody used in the Chlamydia Rapid Test Cassette (Swab/Urine) has been shown to detect all
known Chlamydia serovars. Chlamydia psittasi and Chlamydia pneumoniae strains have been tested
with the Chlamydia Rapid Test Cassette (Swab/Urine), and were shown to cross react when tested in
suspensions of 109 Colony Forming Units (CFU)/ml. Cross reactivity with other organisms has been
studied using suspensions of 109 CFU/ml. The following organisms were found negative when tested
with the Chlamydia Rapid Test Cassette (Swab/Urine):
【BIBLIOGRAPHY】
1. Sanders J.W. et al Evaluation of an Enzyme Immunoassay for Detection of Chlamydia trachmatis in
Urine of Asymptomatic Men. J.Clinical Microbiology, 32,24-27, (1994).
2. Jaschek, G. et al Direct Detection of Chlamydia trachomatis in Urine Specimens from Symptomatic
and Asymptomatic Men by Using a Rapid Polymerase Chain Reaction Assay. J. Clinical Microbiology,
31,1209-1212, (1993).
3. Schachter, J Sexually transmitted Chlamydia trachomatis infection. Postgraduate Medicine, 72, 60-69,
(1982).
For Female Cervical Swab Specimens
For Male Urethral Swab Specimens
Sensitivity
Specificity
For Male Urine Specimens
Cross Reactivity
1,2
Normal carriage rates of Chlamydia in
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