Core Laboratory 
Core Laboratory 

Cancer

Our combination of comprehensive tumor markers and harmonized instrument families provide your laboratory with clinically relevant results for the most debilitating, costly and commonly occurring cancers. Rediscover personalized oncology testing solutions for early detection, diagnosis and monitoring needs.

For in vitro diagnostic use only.

Early Detection

The clinical laboratory can play a key role in the early detection of cancer, which may greatly increase the chances of successful treatment.

Effective Management

Oncology biomarkers can provide affordable, reliable, accurate, non-invasive, and sensitive information to help effectively manage cancer.

Oncology Biomarkers

Approximately 1 in 5 women will develop a pelvic mass in their lifetime. The Risk of Ovarian Malignancy Algorithm (ROMA) calculation can help determine the likelihood that this mass is a malignancy prior to surgery.


Assays engineered to provide reliable assistance in cancer diagnosis and monitoring of patient response to therapy 

Abbott offers a wide variety of assays to test for many types of cancers including, breast, colon, gastrointestinal, liver, ovarian, pancreatic, testicular and prostate cancer. The Abbott oncology solution can help you reduce laboratory operational costs while maintaining the quality standards necessary to have a meaningful positive impact to the quality and cost of health care.

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intended use and important safety information

For In Vitro Diagnostic Use Only

 

CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory. 

 

For complete assay information, see the assay specific package insert.

 

ARCHITECT AFP

Intended Use:  The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of alpha-fetoprotein (AFP) in:

1. Human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer.

2. Human serum, plasma and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (NTD). Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD.

Important Safety Information: The concentration of alpha-fetoprotein (AFP) in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the AFP assay used.  Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining AFP levels serially is changed, additional sequential testing should be carried out. Prior to changing assays, the laboratory MUST:

1. For Cancer Management - Confirm baseline values for patients being serially monitored.

2. For Prenatal Testing - Establish a range of expected values for the new assay based on serum or plasma and amniotic fluid from pregnant women with confirmed gestational age. 

United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

ARCHITECT Free PSA

Intended Use:  The ARCHITECT Free PSA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free prostate specific antigen (PSA) in human serum. The ARCHITECT Free PSA assay is intended to be used in conjunction with the ARCHITECT Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and DRE non-suspicious for cancer to determine the % free PSA value. The ARCHITECT % free PSA value can be used as an aid in discriminating between prostate cancer and benign disease.

Important Safety Information: The concentration of free PSA in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the free PSA assay used. Values obtained with different assay methods cannot be used interchangeably. United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

ARCHITECT Total PSA

Intended Use: The ARCHITECT Total PSA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total PSA (both free PSA and PSA complexed to alpha-1-antichymotrypsin) in human serum: 

1. As an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostatic biopsy is required for diagnosis of cancer.

2. As an adjunctive test to aid in the management of prostate cancer patients.

Important Safety Information: The concentration of total PSA in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the total PSA assay used. Values obtained with different assay methods, including Abbott PSA assays, cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining total PSA levels serially is changed, additional sequential testing should be carried out. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

 

 
 
 
 
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