Treponema Pallidum(TP) Rapid Diagnostic Kit (Colloidal Gold)
For the qualitative detection of Syphilis antibodies in
serum/plasma and whole blood
Main Features
☀ High Sensitivity: 100%
☀ Specificity: 100%
☀ Simple: No Instrument Required
☀ Reliable: Accuracy higher than 97.5%, early detection of the
presence of TP Antibody
☀ Convenient: Room Temperature Storage, Built-In Control
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
Intended Use
The Syphilis Rapid Diagnostic Test is a qualitative test for the
detection of antibodies to Syphilis in human serum/plasma and whole
blood. It is considered as an initial screening test for Syphilis
antibodies. All positive specimens must be confirmed with Western
Blot or other qualified EIA.
Principle
Syphilis Rapid Diagnostic Test is a chromatographic immunoassay
(CIA) for the detection of antibodies to Syphilis in human serum or
plasma. Syphilis specific antigens are precoated onto membrane as a
capture reagent on the test region.
During the test, specimen is allowed to react with the colloidal
gold particles, which have been labeled with Syphilis specific
antigens. Antibodies to Syphilis, if present, a red colored band
will develop on the membrane in proportion to the amount of
Syphilis antibodies present in the specimen.
Absence of this red colored band in the test region suggests a
negative result. To serve as a procedural control, a red colored
band in the control region will always appear regardless the
presence of antibodies to Syphilis. The RDT is simple, rapid,
sensitive and specific.
Reagents and Materials Provided
☀ Blood diluent in a dropper bottle.
☀ One sealed pouched cassette with desiccant & a disposable pipe.
☀ One piece of operating instruction with 40 test pouches.
Assay Procedure
Serum or Plasma Sample
Add 2 drops of serum or plasma into sample well. Observe the result
in 120 minutes.
Whole Blood Sample
Add 1 drop of whole blood into sample well, after all blood
completely absorbed. Add 2 drop of whole blood diluent. Observe the
result in 20 minutes.
Interpretation of Results
Negative:
No apparent band in the test region (T), Only one red band appears
in the control region (C). This indicates that no TP antibodies
have been detected.
Positive:
In addition to one red band in the control region (C), a red band
will appear in the test region (T). This indicates that the
specimen contains TP antibodies.
Invalid:
If no band appears in the control region(C), regardless of the
presence or absence of band in the test region (T). It indicates a
possible error in performing the test. The test should be repeated
using a new device.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for
the duration of the shelf life (24 months).
Warning and Precautions
☀ FOR IN VITRO DIAGNOSTIC USES ONLY.
☀ All patient samples should be treated as if capable of
transmitting diseases.
☀ Do not interchange reagents from different lots or use test kit
beyond expiration date.
☀ Icteric, lipemic, hemolysed, heat treated and contaminated sera
may cause erroneous results.
Precision
Within run and between run precisions have been determined by
testing 10 replicates with three of the samples: a negative, a weak
positive, and a strong positive sample. The negative, weaker
positive, and strong positive samples were correctly identified in
all of the tests every time.
