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
| Method | TPHA | Total Results |
| Syphilis Rapid Test Device | Results | Positive | Negative |
| 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
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.
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
