t-PSA iClia

Intended Use

t-PSA CLIA Kit is intended for the in vitro quantitative measurement of total Prostate Specific Antigen (t-PSA) in human serum/plasma as an aid in clinical observation, prognostic and recurrence monitoring of prostate cancer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result at 25 minutes
• Analytical sensitivity : 0.005 ng/ml.
• Linearity: 0.005 ng/ml. to100 ng/ml.
• Long shelf life: 12 months at 2-8^oC
• Onboard stability of reagents: 30 days at 2-8^oC
• Convenient pack size: 50 Test Pack
• Prompt service back-up

Principle

t-PSA CLIA Kit is a sandwich immunoassay using microparticle acridinium ester-labeled chemiluminescent technology. In the first step, human serum/plasma and anti-t-PSA IgG labeled magnetic microparticle are mixed and incubated in an assay cup, which allows t-PSA in sample to bind to microparticle and forms microparticle-anti-t-PSA antibody/ antigen complex. Next, after washing, AE Conjugate (anti-t-PSA IgG labeled acridinium ester) is added and incubated. The above complex is combined with AE Conjugate and formed microparticle-anti-t-PSA antibody/antigen/antibody immune complex. Excess acridinium ester conjugate is removed by washing and finally the bound acridinium ester is detected by addition of chemiluminescent substrate. The relative light unit (RLU) intensity is proportional to the amount of t-PSA. According to the t-PSA RLU-concentration standard curve, the RLU tested can be interpreted to t-PSA concentration in the sample expressed as ng/mL.

Performance Characteristics

Limit of Blank (LoB) : <0.004 ng/ml.

Accuracy: The accuracy of t-PSA iClia was detected with 60 clinical specimens and compared with Roche CLIA. The co-relation co-efficient is >0.990.

Precision:

1. The test results are repeatable with Prostate-specific antigen (t-PSA) samples (Low and High) and kit controls in within run precision testing with CV <10 %.
2. The test results are reproducible with Prostate-specific antigen (t-PSA) samples (Low and High) and kit controls in between run precision testing with CV <10%.
3. The test results are reproducible with Prostate-specific antigen (t-PSA) samples (Low and High) and kit controls in between instrument precision testing with CV <10%.

Ordering Information