Clearview

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Qualitative detection of Chlamydia trachomatis in both males and females



Frequently Asked Questions

 

 

Is it essential to sample with the Clearview Chlamydia Female Collection kit for endocervical swabs?

Yes. There any many different compositions of swab type and some ingredients may interfere with Clearview Chamydia MF giving false positive results.

 

Can female urine samples or male urethral swabs be tested with the Clearview Chlamydia MF test kit?

No. The test has only been validated for female endocervical swabs (using the female collection kit) and male urine samples.

 

What sort of transport media is required for the female endocervical swabs?

The swab should be transported dry in the transportation tube supplied.  Clearview Chlamydia MF is an antigen detection diagnostic test for Chlamydia trachomatis so it is not essential for the organisms to remain viable. Transport media may interfere with the test so should not be used.  If the endocervical swab is not to be tested within 1 day it may be stored at 2-8oC for up to 5 days but cannot be frozen.

 

Does the male urine sample have to be a first catch urine?

Yes.  The first catch urine must be collected into a clean dry container.  The patients should be instructed not to urinate for at least one hour prior to sample collection. If the urine sample is not to be tested within 6 hours it may be stored at 2-8oC for up to 5 days but cannot be frozen.

 

Does the male urine sample have to be diluted in deionised water?

Yes.  The purpose of using a diluted urine sample is to ensure all salts are dissolved before centrifugation so that only cellular material is spun down on centrifugation.  If the urine is not diluted in deionised water there will be a greater proportion of inhibitory substances present, which may interfere with the test.

 

Can a water bath be used instead of the Clearview Workstation?

Yes.  The use of a water bath is fine provided that the temperature of the water can be maintained at 80oC+/- 2oC.  The water bath should ideally contain a circulating pump.

 

Does the sample extract have to be cooled before adding it to the Clearview device?

Yes, The sample extract must be cooled for a minimum of 5 minutes at 18oC to 30oC before adding 5 drops to the Clearview device.

 

How long can the sample extract be stored?

The extract can be stored at 18oC to 30oC for a maximum of 3 hours.

 

Can the kit be used directly from the fridge?

No.  All components should be allowed to equilibrate at 18oC to 30oC before use.

 

A test line has appeared but it is fainter than the control line.  How should this result be interpreted?

The presence of a test line (no matter what strength) is indicative of a positive result providing that the test was read within the specified time.  The strength of the test line depends on the amount of Chlamydia trachomatis antigen in the sample; hence low-level antigen would result in a weak test line being generated.

 

How long after treatment can an infected patient be tested for cure?

As a guideline it is recommended that a patient be tested for cure no earlier than two weeks after the beginning of treatment.  Testing before this period has elapsed may yield positive results due to non-viable organism, which may not have cleared from the body.  Clearview Chlamydia MF is an antigen detection test for Chlamydia trachomatis so will detect both viable and non-viable organisms.  This clearance will be host related so the timescale is only a guideline.

 

Can Clearview Chlamydia MF diagnostic test detect the other Chlamydiae?

The antibodies used in Clearview Chlamydia MF are directed against the genus-specific lipopolysaccharide epitope of Chlamydia, so the test will also detect Chlamydia psittaci, Chlamydia pneumoniae and Chlamydia pecorum. However the test has only been validated for the detection of Chamydia trachomatis infection from female endocervical and male urine samples.

 


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