商品编号


20229



品牌


Quidel



公司


Quidel,inc.



公司分类


hCG



Size

50/12

商品信息

Description:
Test Kit
Features & Benefits:






Sofia hCG Fluorescent Immunoassay (FIA), with Kinetic Check
TM
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.

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Feature
Benefit



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 Name
Product 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.