Chlamydia Antigen Rapid Test

INTENDED USE
Chlamydia Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis antigen in female cervical swab and male urethral swab specimen. The test results are intended to aid in the diagnosis of Chlamydia infection in people.
 

SUMMAR
MATERIALS

TEST PROCEDURE

1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Extract the Chlamydia antigen according to the specimen type.

• Hold the reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300μl) to the extraction tube. Reagent 1 is colorless. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
• Hold the reagent 2 bottle vertically add 6 drops of reagent 2 (approx. 250μl) to the extraction tube. The solution would turn turbid. Compress the bottle of tube and rotate the swab 15 times until the solution turn clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand 1 minute.
• Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.

1. Place the test cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx. 100μl) to each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
2. Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read 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:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

PERFORMANCE CHARACTERIST

The Chlamydia Antigen Rapid Test has been evaluated with specimens obtained from patients of STD clinics. PCR is used as the reference method. The results show that Chlamydia Antigen Rapid Test has a high sensitivity and specificity relative to the reference method.
Table: Chlamydia Antigen Rapid Test vs. PCR kit  

Method		PCR		Total Results
Chlamydia Antigen Rapid Test	Results	Positive	Negative
	Positive	97	5	102
	Negative	8	324	332
Total Result		105	329	434

Relative Sensitivity: 92.38% (95%CI: 85.54%~96.65%) 
Relative Specificity: 98.48% (95%CI:96.49%~99.50%) 
Accuracy: 97.00% (95%CI:94.93%~98.40%)
Cross-Reactivity
Cross reactivity of Chlamydia Antigen Rapid Test with other organisms has been studied using suspensions of 10⁷ org/test. The following organisms were found negative when tested with the Chlamydia Antigen Rapid Test and did not produce any positive result:

Acinetobacter calcoaceticus	Klebsiella pneumoniae	Proteus mirabilis
Salmonella choleraesius	Neisseria meningitides	Neisseria gonnorhea
Pseudomona aeruginosa	Enterococcus faecium	Candida albicans
Group B/C Streptococcus	Staphylococcus aureus	Proteus vulgaris
Branhamella catarrhalis	Hemophilus influenzae	Gardnerella vaginalis
Enterococcus faecalis

Detection Of Limit
The detection limit of Chlamydia was studied by rapid test of Chlamydia antigen. According to the test results, the lowest detection limit of Chlamydia Antigen Rapid Test is 5*10⁴IFU/mL.
Hook Effect
The Chlamydia Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. Results: The lower the concentration, the weaker the reading. The current test results show that the product does not appear hook effect.