One step High Accuracy Chlamydia Rapid Diagnostic test Cassette , gold colloidal method, easily and quick

One step High Accuracy Chlamydia Rapid Diagnostic test Cassette , gold colloidal method, easily and quick
 
Accessories:
 
Test tubes
Dropper tips
Sterile polyester tipped applicator
(Sterile female cervical swabs)
Reagent A
Reagent B
Workstation
Package insert
 
Intended Use:
 
The Chlamydia Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in clinical specimens to aid in the diagnosis of Chlamydia infection.
 
Test Principle:
 
The Chlamydia Rapid Test Device is a qualitative, lateral flow immunoassay for the detection of Chlamydia antigen from clinical specimens.
In this test, antibody specific to the Chlamydia antigen is coated on the test line region of the strip. 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 generate a red line in the test region. The presence of this red line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a red line will always appear in the control region indicating that proper volume of specimen has been added and membrane wicking has occurred.
 
TEST PROCEDURE
 
Allow the test device, specimen, reagents, and/or controls to reach room temperature prior to testing.
 
 
Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
 
2. Extract the Chlamydia antigen:
 
For Female Cervical or Male Urethral Swab Specimens:
 
(1) Hold the Reagent A bottle vertically and add 5 full drops of Reagent A (approximately 300 µL) to the extraction tube(See illustration ①). Reagent A is colorless. Immediately insert the swab, compress the bottom of the tube and rotate the swab 15 times. Let stand for 2 minutes. (See illustration ②)
 
(2) Hold the Reagent B bottle vertically and add 6 full drops Reagent B (approximately 250ul) to the extraction tube. (See illustration ③) Reagent B is pale yellow. The solution will turn cloudy. Compress the bottom of tube and rotate the swab 15 times until the solution turns to a clear color with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand for 1 minute. (See illustration ④)
 
(3) Press the swab against the side of the tube and withdraw the swab while squeezing the tube. (See illustration ⑤).Keep as much liquid in the tube as possible. Fit the dropper tip on top of the extraction tube. (See illustration ⑥)
 

 
 
For Male Urine Specimens:
 
(1)Hold the Reagent B bottle vertically and add 6 full drops Reagent B (approximately 250ul) to the urine pellet in the centrifuge tube, then shake the tube vigorously mix until the suspension is homogeneous.
 
(2)Transfer all the solution in the centrifuge tube to an extraction tube. Let stand for 1 minute. Hold the Reagent A bottle upright and add 5 full drops of Reagent A (approximately 300 µL) then add to the extraction tube. Vortex or tap the bottom of the tube to mix the solution. Let stand for 2 minutes.
 
(3) Fit the dropper tip on top of the extraction tube.
 
Place the test device on a clean and level surface. Add 3 full drops of extracted solution (approximately 100 µL) to the specimen well (S) of the test device, then start the timer. Avoid trapping air bubbles in the specimen well (S).
 
Wait for the red line(s) to appear. Read the result at 10 minutes. Do not read 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).
 
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies 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).
 
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.
 
PERFORMANCE CHARACTERS:
 
Sensitivity
 
The Chlamydia Rapid Test Device has been evaluated with Chlamydia infected cells and specimens obtained from patients of STD clinics. The Chlamydia Rapid Test Device can detect 106org/mL Chlamydia infected cells. PCR is used as the reference method for the Chlamydia Rapid Test Device. 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 Device has a high sensitivity relative to PCR.
 
Specificity
 
 
The Chlamydia Rapid Test Device uses an antibody that is highly specific for Chlamydia antigen in specimens. The results show the Chlamydia Rapid Test Device has a high specificity relative to PCR.
For Female Cervical Swab Specimens:
 
 

 
 
 
 
For Male Urethral Swab Specimens:
 
 

 
For Male Urine Specimens:
 
 

 
 
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.