Orient New Life Medical Co.,Ltd.

 

Quality is life.

 

Home
Products
About Us
Factory Tour
Quality Control
Contact Us
Request A Quote
Company News
Home ProductsHome Testing Kits

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

Certification
Good quality Home Testing Kits for sales
Good quality Home Testing Kits for sales
We are satisfied with your quality & services so far. The HIV 1/2 antibody Test performance is perfect.

—— Katrina

I have to say that New Life provides high quality products. The FOB, Troponin I, HIV, HCV, Drug Abuse test all performed very well in our market.

—— Clemen

Your Dengue IgG/IgM and Malaria test perfromed well. Now we want to try your Filariasis test in our market.

—— Primo

I'm Online Chat Now

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

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

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

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Price: USD0.15-USD1
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
Detailed Product Description
Category: Infectious Format: Strip/cassette
Specimen: Swab Testing Time: 5-15 Minutes
Shelf Life: 24 Months Accuracy: 96.72%
Application: Chlamydia

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

Method PCR Total Results  

Chlamydia Rapid
Test Device

Results Positive Negative RelativeSensitivity:87.5%
Positive 35 3 38 RelativeSpecificity:96.5%
Negative 5 83 88 RelativeAccuracy:93.7%
Total Results 40 86 126  

 
 
 
 
For Male Urethral Swab Specimens:
 
 

Method PCR Total Results  

Chlamydia Rapid
Test Device

Results Positive Negative RelativeSensitivity:82.7%  
Positive 43 6 49 Relativespecificity:93.9%  
Negative 9 93 102 RelativeAccuracy:90.1%  
Total Results 52 99 151  

 
For Male Urine Specimens:
 
 

Method PCR Total Results    
 

Chlamydia Rapid
Test Device

Results Positive Negative   RelativeSensitivity:87.5%
  Positive 21 1 22 RelativeSpecificity: 98.0%
  Negative 3 50 53 Relative Accuracy: 94.7%
  Total Results 24 51 75    

 
 
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.
 
 
 

ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry

 
 
 
 
 

Contact Details
Orient New Life Medical Co.,Ltd.

Contact Person: Jerry Meng

Send your inquiry directly to us (0 / 3000)