One Step Syphilis Home Test Kit 4mm Strip Rapid Chromatographic Immunoassay

Private Syphilis blood Home Testing kits, 99% accuracy, 4mm cassette home use test kit.

Product Name:

Syphilis blood Home Testing kits

Intended Use:

The Syphilis Rapid Test Device (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.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

EXPECTED VALUE

The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) has been compared with a leading commercial TPHA Syphilis test, demonstrating an overall accuracy greater than or equal to 99.4%.

PERFORMANCE CHARACTERS:

Clinical Sensitivity, Specificity and Accuracy

The Syphilis Rapid Test Device (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 Device vs. TPHA

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

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 negative, low positive, medium positive and high positive values 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 Rapid Test Device (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.