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%
☀ Reliable: Accuracy higher than 97.5%, early detection of the
presence of TP Antibody
☀ Convenient: Room Temperature Storage, Built-In Control
☀ Simple: No Instrument Required
☀ 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.
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.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for
the duration of the shelf life (24 months).
Sample Collection and Preparation
Whole Blood ( Finger stick Specimens)
☀ Clean the area to be lanced with an alcohol swab.
☀ Squeeze the end of the fingertip and pierce it with a sterile
lancet.
☀ Wipe away the first drop of blood with sterile gauze or cotton.
☀ Allow the second drop to flow directly into a sample well.
Plasma
☀ Have a certified phlebotomist collect whole blood into a purple,
blue or green top collection tube (containing EDTA, citrate or
heparin, respectively) by veinpuncture.
☀ Separate the plasma by centrifugation.
☀ Carefully withdraw the plasma for testing or label and store it
at 4°C for up to five days. Plasma may be frozen at -20°C for at
least three months.
Serum
☀ Have a certified phlebotomist collect whole blood into a red top
collection tube (containing no anticoagulants) by veinpuncture.
☀ Allow the blood to clot.
☀ Separate the serum by centrifugation.
☀ Carefully withdraw the serum for testing or label and store it at
4°C for up to five days. Serum may be frozen at -20°C for at least
three months.
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.
Limitation
1. This Rapid Test is a qualitative test for the detection of
anti-Tp antibody in human serum or plasma. The intensity of the
test band does not correlate with the antibody concentration in the
specimen.
2. A negative result for an individual subject indicates absence of
detectable anti-Tp antibodies . However, a negative test result
does not preclude the possibility of exposure to or infection with
Tp.
3. A negative result can occur if the quantity of the anti-Tp
antibody present in the specimen is below the detection limits of
the assay, or the antibodies that are detected are not present
during the stage of disease in which a sample is collected.
4. Some specimens containing unusually high titer of heterophile
antibodies or rheumatoid factor may affect expected results.
5. The results obtained with this test should only be interpreted
in conjunction with other diagnostic procedures and clinical
findings.
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.
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.
