Chlamydia MF Test (Clearview)

Clearview Chlamydia MF is a rapid immunoassay for the direct qualitative detection of Chlamydia trachomatis antigen in either female endocervical swab specimens or male urine specimens.

Principle:
Chlamydia antigen is extracted from the swab or urine pellet specimen at 80ºC with extraction reagent (R1). Following the extraction, the only one-step required is to add the extract to the sample window of the test unit. The appearance of a line in the result window indicates the presence of chlamydial antigen. The absorbent pad in the sample window contains a latex-labeled monoclonal antibody directed against agenus-specific lipopolysaccharide epitope of Chlamydia. The extract rehydrates the labeled antibody and the extracted antigens react with this to form a complex. The pad is in contact with a test strip which contains a region of immobilized monoclonal anti-Chlamydia antibody in the result window. The extract-latexmixture moves by capillary action along the strip.

• The formation of a line in the RESULT window indicates the presence of chlamydial antigen in the extract. The line is formed due to the binding of the chlamydial antigen to the latex-labelled antibody and the subsequent immobilization of this complex by the zone of antibody located in the Result window. If no antigen is present, the Result window will remain clear. 
• Do not freeze 

Procedure:
Note: Ensure that the heating apparatus is at 80°C ± 2°C, and all reagents, devices and specimens are at 18-30°C before beginning the assay.

1. Female Endocervical Swab Specimen
    Preparation:(No specimen preparation required) 

    Extraction:

• Ensure heating apparatus is at 80ºC ± 2ºC. 
• Place the tube into the heating apparatus and leave for 10-12 minutes. 
• Remove the tube and rotate the swab in the tube. 
• Remove liquid from the swab by pinching the rim of the extraction tube between thumb and finger and gently removing the swab from the tube. 
• Discard the swab. 
• Allow the swab extract to cool for at least 5 minutes at room temperature. The extract can remain at room temperature for up to 3 hours without affecting the result of the test. 
• Remove a test unit from the foil .
• Cap the extraction tube with the attached dropper and apply 5drops of extract to the Sample Window of the test unit. 
• Read the test fifteen minutes after adding the extract to Sample Window. Test results remain stable for up to 20 minutes. 

2. Male Urine Specimen
    Preparation:

• Mix the urine specimen by collection. 
• Transfer 10 ml of the urine specimen into a centrifugation tube and add 10 ml of distilled water.
• Centrifuge the specimen at 3000g for 15 minutes. 
• Carefully pour off the supernatant and discard. 
• Keep the tube inverted and remove any supernatant from the rim of the tube by blotting onto absorbent paper. 

    Extraction: 

• Ensure heating apparatus is at 80ºC. Remove the dropper from the bottle of R1 and pipette 0.6 ml into the tube. 
• Vortex mix for a minimum of 30 seconds. 
• Transfer the resuspended pellet to the extraction tube. 
• Place into the heating apparatus and heat for 10-12 minutes. 
• Remove the tube and allow to cool for at least 5 minutes at room temperature. The extract can remain for up to 3 hours without affecting the result. 
• Remove a test unit from the foil and cap the extraction tube with the attached dropper, and apply 5 drops of extract to the Sample Window. 

Interpretation:

• A line appearing in the Control Window (C) within 15 minutes shows that the test has worked correctly. If no line appears in the Control Window within 15 minutes the test must be repeated with a new Clearview Chlamydia MF device. The remaining extract can be used for this purpose provided it has been prepared for less than 3 hours. Alternatively, a fresh specimen may be collected following the procedures described earlier. 
• A positive result is indicated by a line in the Result Window (B) at 15 minutes. A difference of intensity may occur between the lines in the Result and the Control Windows, but this does not affect the interpretation of the results. A negative result is indicated if no line has formed in the result window at the 15 minute read time.