Rapid Detection with RSV Rapid Test for Chlamydia
PRINCIPLE
It 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.
Product Detail
Brand: QL
Specimens: Urine/ Male Urethral Swab/ Female Cervical Swab
Reading time： 20 minutes.
Pack：20 T
STORAGE 2‐30°C
Materials
Materials Provided
Test devices
Test tubes
Dropper tips
Sterile polyester tipped applicator (Sterile female cervical swabs)
Reagent A
Reagent B
Workstation
Package insert
PRECAUTIONS
Please read all the information in this package insert before performing the test.
●For professional in vitro diagnostic use only. Do not use after expiration date.
●Do not eat, drink or smoke in the area where the 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 the standard procedures for proper disposal of specimens.
●Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
●Humidity and temperature can adversely affect results.
●Use only sterile swabs to obtain endocervical specimens.
●Tindazole vaginal effervescent tablets and Confort Pessaries with negative specimens may cause very weak interference effect.
DIRECTIONS FOR USE
Allow the test device, specimen, reagents, and/or controls to reach room temperature (15‐ 30 C) 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.Extract the Chlamydia antigen:
For Female Cervical or Male Urethral Swab Specimens:
- Hold the Reagent A bottle vertically and add 4 full drops of Reagent A(approximately 280 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)
- Hold the Reagent B bottle vertically and add 4 full drops Reagent B (approximately 240ul) 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)
- 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:
- Hold the Reagent B bottle vertically and add 4 full drops Reagent B (approximately 240ul) to the urine pellet in the centrifuge tube, then shake the tube vigorously mix until the suspension is homogeneous.
- 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 4 full drops of Reagent A (approximately 280 µL) then add to the extraction tube. Vortex or tap the bottom of the tube to mix the solution. Let stand for 2 minutes.
- Fit the dropper tip on top of the extraction tube.
Wait for the red line(s) to appear. Read the result at 10 minutes.Do not read the result after 20 minutes.
INTERPRETATION OF ASSAY RESULT
POSITIVE RESULT:
* A colored band appears in the control band region (C) and another colored band appears in the T band region.
NEGATIVE RESULT:
One colored band appears in the control band region (C). No band appears in the test band region (T).
INVALID RESULT:
Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
*NOTE: The intensity of the red color in the test line region (T) may vary depending on the concentration of Chlamydia antigen presents in the specimen. Therefore, any shade of red in the test region (T) should be considered positive.
The Chlamydia Rapid Test Device by QL Biotech harnesses the specificity and sensitivity required to detect the Chlamydia antigen efficiently. Upon introduction to a clinical specimen, the device initiates a lateral flow immunoassay process. This involves the migration of the specimen across a matrix that contains specific antibodies. If Chlamydia antigens are present, they bind to these antibodies, producing a visible signal within minutes. This rapid and straightforward procedure ensures healthcare professionals can make informed decisions promptly, significantly reducing the anxiety of waiting for patients and potentially curbing the spread of the infection through faster intervention. Moreover, integrating the Chlamydia Rapid Test Device into clinical practice underscores a substantial leap towards enhancing patient care. Its ease of use, combined with minimal training requirements, empowers healthcare workers across various settings to conduct the test. This democratization of testing capabilities is crucial in tackling Chlamydia infections, which require timely diagnosis to prevent severe complications. In sum, the Chlamydia Rapid Test Device by QL Biotech is not merely a tool but a testament to the synergy of innovation and care, aiming to revolutionize the landscape of infectious disease diagnostics with speed, reliability, and accessibility at its core.