11dhTxB₂ ELISA Test Kit
INTENDED USE
Complete ELISA kit-ready-to-use reagents
96-well microplate format
Single wash step
Assay time-2.5 hours
BACKGROUND
1.Aspirin,the foundation of antiplatelet therapy in cardiovascular
medicine,is widely prescribed by physicians to prevent heart attack
and stroke.It is estimated that more than 150,000 heart attacks
each year could be prevented by the appropriate use of aspirin
therapy.
2.Recently,physicians discovered that a significant number of
individuals taking dosages of aspirin
considered therapeutic were experiencing vascular thrombotic events
including acute coronary
syndromes,transient ischemic attacks,strokes and peripheral
vascular events.In addition,clinical researchers,utilizing a
variety of laboratory tests, discovered that some patients have a
reduced or minimal response to aspirin administration.
3.Test Kit is a quantitative enzyme-linked immunoassay (ELISA)to
determine levels of 11-dehydro thromboxane B2 (11dhTxB2) in human
urine,which aids in the determination of platelet response to
aspirin ingestion.
Product list
| Product details | Description |
| Delivery | Within 48 hours |
| Packaging Specifications | 5*8 x 12 strips, 480 wells |
| Country Of Origin | China |
| Manufacturer | 18 months |
| Preservation method | 2℃-8℃ |
| Specimen | Urine |
| Assification | class1 |
| Type | Elisa Test Kit |
PRINCIPLE AND PROCEDURE
Test Kit measures urinary 11-dehydrothromboxane B2(11dhTxB2)and is
performed as acompetitive ELISA.Diluted samples,purified 11dhTxB2
conjugated to alkaline phosphatase(AP),purified mouse monoclonal
antibody directed to 11dhTxB2 are combined and incubated in
microwells coated with a polyclonal anti-mouse antibody. Incubation
allows the endogenous 11dhTxB2 present in the samples to compete
with the purified AP-conjugated 11dhTxB2 for binding to the mouse
monoclonal anti-11dhTxB2 antibody.The monoclonal antibody then
binds to the polyclonal anti-mouse antibody coated on the
microtiter plate.The complex formed on the plate is composed of
monoclonal antibody and endogenous or AP-conjugated 11dhTxB2.After
the removal of unbound complexes by washing,the bound AP-11dhTxB2
conjugate is assayed by the addition of paranitrophenylphosphate
(pNPP)chromogenic substrate.Color develops in the wells at an
intensity inversely proportional to the sample urine concentration
of 11dhTxB2,and is read on a spectrophotometer at 405nm.Results
(pg/mL)are calculated against a reference curve prepared from the
Reference Solution provided in the kit.Final results are reported
as pg 11dhTxB2 per mg creatinine to normalize results for urine
concentration.
CLINICAL PERFORMANCE
Results are presented as positive or negative,based on a cutoff of
1500 pg 11-dehydro thromboxane B2 per mg urinary creatinine.The
detection range for 11-dehydro thromboxane B2 in the test is
300-4000 pg/mL urine.For greatest accuracy,samples that generate
values greater than 4000 pg/mL should be retested at an appropriate
dilution.The analyte concentration reported should be normalized by
dividing the measured 11 dhTxB2 by the concentration of urine
creatinine as measured by a separate assay.The test kit was
evaluated for intra-assay(72 replicates per sample within 1 kit
lot)and inter- assay(216 replicates per sample over 3 kit lots)
precision using the kit urine controls.Results are summarized in
the following table:
Control
| Overall Mean 11-dehydro thromboxane B2Concentration | Intra-assay mean CV% | Inter-assay mean CV% |
| 1 | 548 pg/mL | 10% | 13% |
| 2 | 915 pg/mL | 5% | 8% |
| 3 | 1765 pg/mL | 4% | 5% |
FEATURE
· Random Urine Sample
· Results reported as:
≤1500 pg 11dhTxB₂/mg of creatinine=ASPIRIN RESPONDER
>1500 pg 11dhTxB₂/mg of creatinine=ASPIRIN NON-RESPONDER
· Urinary 11-dehydro Thromboxane B₂ measurement
· Quantitative measurement of 11-dehydro Thromboxane B₂in human
urine which aids in the qualitative detection of acetylsalicylic
acid (ASA)effect
· NEW CAP(College of American Pathologists) proficiency sample
available beginning 2012. Three (3)samples twice per year-listed
under CAP:COAGULATION Code TBX
· Assay formats available for both manual and select automated
platforms
PREPARATIONS
1. Allow all specimens and reagents to reach room temperature
(~25°C) and mix thoroughly by gentle inversion before use.
2.Prepare Wash Buffer by diluting Wash Concentrate 20-fold with
deionized water. The diluted wash solution is stable in room
temperature for at least one week.
PRECAUTION FOR USERS
1. Handling should preclude any pipetting by mouth. Use only
pipettes with disposable tips for each specimen.
2.Do not mix materials from different master lots. Do not use kit
components beyond the expiration date.
3.All materials should be brought to room temperature before use.
