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Sofia hCG Fluorescent Immunoassay (FIA), with Kinetic CheckTM technology uses advanced immunofluorescence-based lateral-flow technology to detect human Chorionic Gonadotropin (hCG) in urine specimens. Sofia hCG FIA uses monoclonal antibodies specific to the beta subunit of hCG to capture and detect hCG, which enhances specificity as the alpha subunit of hCG is nearly identical to the alpha subunit found in LH, FSH and TSH.

To perform the Sofia hCG FIA, a urine specimen is collected and dispensed into the Sample Well on the Test Cassette. The Cassette is placed inside Sofia for an automatically defined development time.

The Kinetic Check technology gives the user greater flexibility, up to 5 minutes, before placing the Cassette into Sofia for analysis.

Sofia will scan the test strip and measure the immunofluorescent signal by processing the results using method-specific algorithms. The test results can also be automatically printed on an integrated printer if this option is selected.

An internal control line helps ensure that the rapid hCG test has been executed properly, that the kit reagents are performing appropriately, and that adequate flow has occurred through the test strip. Another fluorescent line should form at the Control position on the test strip each time a specimen or control is tested. If no control line is detected, the test will be reported as invalid by Sofia. The enhanced sensitivity of the Sofia hCG FIA gives you accuracy and confidence in rapid testing.

Sofia hCG FIA is one in a growing menu of the fluorescent antibody tests available for use on Sofia. This easy-to-use qualitative fluorescent test can be used as an aid in the early detection of pregnancy.

 

Features & Benefits

FeatureBenefit

Kinetic Check technology

Helps prevent interpretation of overdeveloped test cassettes

Monoclonal antibodies specific to the beta subunit of hCG

Ensures greater specificity in the presence of LH, FSH and TSH

Results in 3 minutes

Fast time to results for truly rapid pregnancy testing

Objective result

Eliminates the subjectivity of a visual result

Room temperature storage

No refrigerator space needed. No need to wait for reagents to warm up. Rapid hCG tests can be run immediately as needed

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Urine

Positive agreement*

>99%

Negative agreement*

>99%

Shelf life

18 months from date of manufacture

CLIA complexity

Moderate

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
20229

Test Kit

50/12
20266 XUS

Test Kit

50/12