Syphilis Antibody Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HTP063T
• Blood Sampling Needle: None
• 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
Syphilis Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.

SUMMAR
MATERIALS

Materials Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge Micropipette

Timer Lancets

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 mL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer.

1. Wait for the colored line(s) to appear. Read results 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 TP antibodies 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 TP antibodies 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 Syphilis Antibody Rapid Test has correctly identified specimens of a performance panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens.

Method		TPPA		Total Results
Syphilis Antibody Rapid Test	Results	Positive	Negative
	Positive	101	8	109
	Negative	3	94	97
Total Result		104	102	206

Relative Sensitivity: 97.12% (95%CI: 91.80%~99.40%)
Relative Specificity: 92.16% (95%CI: 85.13%~96.55%)
Accuracy: 94.66% (95%CI: 90.65%~97.30%)
Cross-Reactivity
Cross reactivity of Syphilis Antibody Rapid Test with other positive specimens has been studied. The following positive specimens were found negative when tested with the Syphilis Antibody Rapid Test and showed no cross-reactivity.

HAMA	RF	HBsAg
HBsAb	HBeAg	HBeAb
HBcAb	HCV	HIV
H. Pylori	MONO	CMV
Rubella	TOXO

Detection Of Limit
The results show that the minimum detection limit of Syphilis was 10 times dilution. The minimum detection limit for Syphilis is 20 times dilution.
Hook Effect
The present test results show that the hook effect of Syphilis is 128 times higher.

Precision

Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 10 independent assays on the same four specimens:a negative, a low positive, a medium positive and a high positive. Three different lots of the Syphilis Antibody Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.