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Atellica IM total PSA II (tPSAII) assay is for in vitro diagnostic use in the quantitative measurement of total prostate-specific antigen (PSA) in human serum and plasma (EDTA and lithium-heparin) using the Atellica IM Analyzer.

This assay is indicated as an aid in the detection of prostate cancer in conjunction with a digital rectal exam (DRE) in men aged 50 years and older. Prostate biopsy is required for diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.

The Atellica IM total PSA II (tPSAII) assay consists of:

tPSAII ReadyPack® primary reagent pack

• Lite Reagent (10.0 mL/reagent pack): Unlabeled monoclonal mouse anti-fPSA antibody (~250 ng/mL); monoclonal mouse anti-PSA antibody (~180 ng/mL) labeled with acridinium ester; buffer; bovine serum albumin (BSA); preservative.
• Solid Phase (20.0 mL/reagent pack): Monoclonal mouse anti-PSA antibody (~3.5 μg/mL) labeled with biotin and bound to streptavidin paramagnetic particles; buffer; BSA; bovine gamma globulin (BGG); sodium azide (< 0.1%); preservative.
  • Storage: Unopened at 2–8°C (Until expiration date on product), Onboard (42 days).

tPSAII CAL (2.0 mL/vial): Purified PSA from human seminal fluid in buffer; BSA; NaN3 (< 0.1%).

• Storage: Unopened at 2–8°C (Until expiration date on product), Opened at 2–8°C (30 days), On the system at room temperature (8 hours).

The tPSAII assay will have two configurations: 100 tests kit and 500 tests kit (5 x 100T in the carton).

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