Candida Albicans, Trichomonas Vaginalis and Gardnerella Vaginalis Antigen Combo Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HTCG070G
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The Candida albicans, Trichomonas vaginalis and Gardnerella Vaginalis Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Candida albicans antigen, Trichomonas vaginalis antigen and Gardnerella Vaginalis antigen in female cervical swab and male urethral swab specimen. The test results are designed to help diagnose people with candida albicans infections, trichomonas vaginalis infections, and Gardnerella vaginalis infections.  
 

SUMMAR
MATERIALS

Materials Provided

Individually packed test devices	Dropper tips
Buffer	Workstation
Disposable sampling swabs (Female Cervical)	Extraction Tubes
Package insert
Materials Required but Not provided
Sterile Male Urethral Swabs	Timer

TEST PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

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 Candida albicans, Trichomonas vaginalis antigen and Gardnerella vaginalis antigen according to the specimen type.

• For Female Cervical or Male Urethral Swab Specimen:

• Hold the buffer bottle vertically and add 10 drops of buffer (approx. 300μl) to the extraction tube. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
• 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 4 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.

Note: It is recommended to use the buffer within 6 months after opening the vial.

 

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

Clinical Sensitivity, Specificity and Accuracy

The Candida albicans, Trichomonas vaginalis and Gardnerella Vaginalis Antigen Combo Rapid Test has been evaluated with specimens obtained from patients of STD clinics. Culture is used as the reference method.  The results show that Candida albicans Antigen, Trichomonas vaginalis Antigen and Gardnerella vaginalis Antigen Combo Rapid Test has a high sensitivity and specificity relative to the reference method.
Table: Candida albicans Antigen Rapid Test vs. Culture

Method		Culture		Total Results
Candida albicans Antigen Rapid Test	Results	Positive	Negative
	Positive	125	6	131
	Negative	3	107	110
Total Result		128	113	241

Relative Sensitivity: 97.66% (95%CI: 93.30%~99.51%)
Relative Specificity: 94.69% (95%CI: 88.80%~98.03%)
Accuracy: 96.27% (95%CI: 93.03%~98.28%)
Table: Trichomonas vaginalis Antigen Rapid Test vs. Culture 

Method		Culture		Total Results
Trichomonas vaginalis Antigen Rapid Test	Results	Positive	Negative
	Positive	96	5	101
	Negative	6	202	208
Total Result		102	207	309

Relative Sensitivity: 94.12% (95%CI: 87.64%~97.81%)
Relative Specificity: 97.58% (95%CI: 94.45%~99.21%)
Accuracy: 96.44% (95%CI: 93.72%~98.21%)
Table: Gardnerella vaginalis Antigen Rapid Test vs. Culture 

Method		Culture		Total Results
Gardnerella vaginalis Antigen Rapid Test	Results	Positive	Negative
	Positive	99	6	105
	Negative	4	200	204
Total Result		103	206	309

Relative Sensitivity: 96.12% (95%CI: 90.95%~98.93%)
Relative Specificity: 97.09% (95%CI: 93.77%~98.92%)
Accuracy: 96.76% (95%CI: 94.13%~98.44%)
Cross-Reactivity
Cross reactivity of Candida albicans Antigen, Trichomonas vaginalis Antigen and Gardnerella vaginalis Combo Rapid Test with other organisms has been studied using suspensions of 10⁷ org/test. The following organisms were found negative when tested with the Candida albicans Antigen , Trichomonas vaginalis Antigen and Gardnerella vaginalis 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	Proteus vulgaris
Group B/C Streptococcus	Staphylococcus aureus	Enterococcus faecalis
Branhamella catarrhalis	Hemophilus influenzae

Detection Of Limit
The detection limit of Candida albicans was studied by rapid detection of Candida albicans antigen. According to the test results, the lowest detection limit of this product is 3x10⁶ CFU/ml.
The detection limit of Trichomonas vaginalis was studied by rapid detection of Trichomonas vaginalis antigen. According to the test results, the lowest detection limit of this product is 5x10⁴ org/ml.
The detection limit of Gardnerella vaginalis was studied by rapid detection of Gardnerella vaginalis antigen. According to the test results, the lowest detection limit of this product is 0.27×10⁴CFU/ml.
Hook Effect
The Candida albicans Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. The hook effect of the product was 3×10⁹ CFU/ml by rapid detection of
Candida albicans antigen.
The Trichomonas vaginalis Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. The hook effect of the product was 5x10⁸ org/ml by rapid detection of
Trichomonas vaginalis antigen.
The Gardnerella vaginalis Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. The hook effect of the product was 0.27×10⁹CFU/ml by rapid detection of
Gardnerella vaginalis.