One Step Chlamydia Rapid Test (Secretion/Swab) Cassette STD Rapid Screen Test

【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.

【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, untilmost of the tip is no longer visible. This will permit acquisitionof columnaror cuboidal epithelial cells which are the main reservoir of chlamydiaorganisms. Firmly rotate the swab for 15 - 20 seconds without contaminationwith exocervical or vaginal cells.

• If the swab may be tested immediately, replace the swab intotheextractiontube.

For male urethral specimens:

• Standard wire-shafted fiber-tipped swabs or cytology brushes (not provided)should be used for urethral specimen collection. Instruct the patientsnottourinate at least one hour prior to specimen collection.

• Insert the swab 2-4 cm into the urea, rotate for 3-5 seconds andwithdrawit.If the swab may be tested immediately, replace the swab intotheextractiontube.

For male urine specimens:

• Collect 15-30 mL of clean first morning urine in a sterile urinecup. Firstmorning urine specimens are preferred to achieve the highest concentrationsof Chlamydia antigen.

• Mix the urine specimen by inverting the container. Transfer 10mLoftheurine specimen into a centrifuge tube, add 10 mLdistilledwaterandcentrifuge at 3,000 rpm for 15 minutes.

• Carefully discard the supernatant, keep the tube inverted andremoveanysupernatant from the rim of tube by blotting onto absorbent paper.

• If the test is to be conducted immediately, treat the urine pellet accordingtothe Directions for Use.

• Do not place the swab in any transport device containing medium. Transportmedium interferes with the assay, and viability of organisms is not requiredfor the assay. If immediate testing is not possible, patient samplesshouldbeplaced in a dry transport tube for storage or transport. The swabsmaybestored 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 24hours.Do not freeze. All specimens should be allowed to reach a roomtemperatureof 15- 30°C before testing.

【DIRECTION OF USE】

Allow the test, specimen, reagents, and/or controls toreachroomtemperature (15- 30C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and useit assoonaspossible. Best results will be obtained if the test is performedimmediatelyafter 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 Ragent1tothe extraction tube.

• Immerse the patient swab into the extraction tube and wait 2minutes. Whilewaiting, use a circular motion to roll the swab against thesideoftheextraction tube so that the liquid is expressed fromthe swab andcanreabsorb.

• Add 6 drops of Reagent 2. Squeeze the swab firmly against thetubetoexpelas much liquid as possible from the swab for 1 minute. Discardtheswabfollowing guidelines for handling infectious agents. Fit the dropper tipontopof the extraction tube.

• The extracted specimen can remain at roomtemperature for 60minuteswithout 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.

【PERFORMANCE CHARACTERISTIC】

Chlamydia Rapid Test vs. PCR

Female Cervical Specimens:

Relative Sensitivity 99.99%

Relative Specificity 99.90%

Male Urethral Specimens:

Relative Sensitivity 99.99%

Relative Specificity 99.88%

Male Urine Specimens:

Relative Sensitivity 99.99%

Relative Specificity 99.90%

Cross-Reactivity

The antibody used in the Chlamydia Rapid Test has been shown to detect all known Chlamydia serovars. Chlamydia psittasi and Chlamydia pneumoniae strains have been tested with the Chlamydia Rapid Test (Swab/Urine), and were shown to cross react when tested in suspensions of 10 9 Colony Forming Units (CFU)/mL.