CE marked Women health Chlamydia Trachomatics Antigen Rapid Test Kit

Introduction

Intende to use

Rapid immunoassay for direct qualitative detection of Chlamydia trachomatis antigen from endocervical or endourethral swab specimens.

Specimen collection  medical diagnostic CT rapid  test kits

For female endocervical specimens:

• Use only Dacron tipped sterile swabs. It is recommended to use the swab supplied by the kits manufacturer. Swabs with cotton tips are not recommended
• Before specimen collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard . With the swab , insert into the endocervix and pass the squamocolumnar junction until most of the tip is no longer visible. This will permit acquisition of columnar or cubical epithelial cells which are the main reservoir of Chlamydia organism. Firmly rotate (clockwise or anticlockwise) the swab in a circle and stay for 5-10 seconds without contamination with exocervical or vaginal cells
• Put the swab into the extraction tube, if the test may be run immediately

For male urethral specimens:

• Standard Dacron tipped sterile swabs should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection
• Insert the swab into the urethra about 2-4cm; firmly rotate (clockwise or anticlockwise) a circle and stay for 5-10 seconds , withdraw it, and place it into the extraction tube, if the swab may be tested immediately. If not, place the specimen into a dry transport tube for transport and storage. The swabs maybe stored for 4-6 hours at room temperature (15-30°C) or 24-48 hours at 2-8°C, freeze is forbidden.
• All specimens should be brought back into room temperature of 15-30°C before testing.

For male urine specimens

• Collect the first urine (approximately 15-30ml) in the morning. The maximum of C.trachomatics antigens can be detected from the first urine in the morning.
• Specimen should be stored 24 hours at 2-8°C, if immediate testing is not allowed
• Shake and mix the specimen, 10ml specimen is drawn into centrifugal tube with 10ml distilled water, centrifugate the mixture at 3000rpm/s for 15-20 mins.
• Discard the supernatant carefully. Turn over the centrifugal tube, absorb the residual urine with absorbent paper.

Operating Steps 

Prepare endocervical or Urethral swab specimens:

1)     Add 5-6drops (approximately 200µl) of Lysis solution A into the extraction tube vertically. Immerse the specimen swab into the extraction tube. Squeeze the tube and twirl the swab for 15 times. Then keep the swab in the extraction tube for 2 mins

2)     Add 5-6drops (approximately 200µl) of Lysis solution B into the same extraction tube.Deposit may be produced in the mixture. Squeeze the tube and twirl the swab for 15 times. Then keep the swab in the extraction tube for one minute. The solution will be brown if the swab with blood. Wring all extractive from swab and discard the swab. Finally, cover the extraction tube with a filtration tip.

Prepare urine specimen

Add 5-6 drops (approximately 200µl) of Lysis solution B into the tube. Shake to mix well (use vortex mixer if necessary). Transfer the mixture from centrifugal tube to extraction tube, add 5-6 drops (approximately 200µl) of Lysis solution A, and squeeze the wall of tube 15 times and stay for one minute.

Performance procedure 

Dispense 2 drops of extracted samples from extraction tube to the sample well(S) on the test cassette, read the result within 10-15 minutes.  Do not interpret the result after 15 minutes 

Performance Characteristics

1.     Positive Coincidence Rate:100%

2.     Negative Coincidence Rate:100%

3.     Analytical Sensitivity:The detection value of C.trachomatics should be higher than 2x10³  IFU/ml

4.     Analytical Specificity: Compared with 8 different kinds infection factors and the test coincidence rate is 8/8.

5.     Intra-batch Discrepancy: The test results are same in one batch

6.     Inter-batch Discrepancy: The test results are same in different batch

Storage and stability

• The kit should be stored at 2-30°C in a cool and dry place, protected from light
• The validity duration is 12 months
• Do not freeze.
• Do not use after the expiration date indicated on the package.

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