CE Marked Syphilis Test Kit Factory | Diagnostic Medical Device

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. Clinical Sensitivity, Specificity and Accuracy The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPHA Syphilis test using clinical specimens. The results show that the relative sensitivity of The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is 99.5% and the relative specificity is 99.3%.

Syphilis Rapid Test vs. TPHA

Method		TPHA		Total Results
Syphilis Rapid Test	Results	Positive	Negative	Total Results
	Positive	394	4	398
	Negative	2	540	542
Total Results		396	544	940

Relative sensitivity: 99.5% (98.2%-99.9%)* Relative specificity: 99.3% (98.1%-99.8%)* Accuracy: 99.4% (98.6%-99.8%)* * 95% Confidence Intervals

INTENDED USE

The Syphilis Rapid Test (Whole Blood/Serum/Plasma) 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.

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1.Professional Manufacturer, a national-level technologically advanced "giant" enterprise. 2.Deliver goods as order request 3.ISO13485, CE, Prepare various shipping documents 4.Reply customers questions within 24 hours

Test Diagnostic Medical Device CE marked Syphilis Test kit

PRODUCTS DETAILS

INTENDED USE

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