Rapid PSA Test Card

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

China

Article:

1С05С2

Brief description:

Rapid PSA Test is an immunochromatography based one step in vitro test. It is designed for the rapid semi-quantitative determination of human prostate specific antigen (PSA) in serum, plasma or whole blood specimens. Rapid PSA Test is not for the use of the diagnosis of prostate cancer. It may be used as the aid for monitoring PSA level for the management of prostate cancer.

Appointment:

Semi-quantitative determination of human prostate specific antigen (PSA) in serum, plasma or whole blood specimens.

Materials provided:

1. Rapid PSA Test.
2. Instruction for use.

Materials required but not provided:

1. Whole Blood or Plasma: Vacuum Tube or Other Tube Containing Heparin or EDTA as Anticoagulant.
2. Serum: Vacuum tube or other tube containing no anticoagulant.
3. Timer or clock.

Semi-quantitative assay

It identifies if the PSA in human serum, plasma or whole blood is higher than 4 ng/ml or not. The exact concentration of the PSA cannot be determined by this assay. The test is intended to distinguish a normal PSA level result from a presumptive positive result. All positive results must be confirmed using a quantitative PSA assay.

Sensitivity:

Rapid PSA test can detect PSA in in serum, plasma or whole blood with concentration of 4.0 ng/ml or greater.

Accuracy:

100 clinical specimens containing PSA at the concentration between 0.1 and 2012 ng/ml were tested. The study showed the 100% of the specificity and 98.3% of the sensitivity.

Sample type

whole blood / serum / plasma