PRODUCT INFO

About Inverness Medical TestPack® hCG Urine

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testpack_urine_boxInverness Medical TestPack® hCG Urine is a rapid immunoassay for the qualitative detection of human Chorionic Gonadotrophin (hCG) in urine for early detection of pregnancy.

Urine is added to the Sample Well of the reaction disc with the aid of a transfer pipette, and allowed to migrate through the membrane until it reaches the End of Assay Window. As the urine proceeds through the membrane, it mobilises the anti hCG monoclonal antibody-colloid. If hCG is present in the sample, it will form a complex with the antibody-colloid. The antibody-colloid complex migrates through the membrane and is captured by the immobilised anti hCG monoclonal antibody in the result window, providing a visual indication of the presence of hCG.

The test should be read when the End of Assay Window has turned pink/red. If hCG is present in the urine at levels of 25mIU/ml or greater, a Plus sign (+) appears in the result window. A Minus sign (-) indicates no hCG was detected.

TestPack  hCG Urine also provides the following integral control features:

  • The plus/minus format provides an easy to interpret result for positive and negative patient samples.
  • The appearance of a pink/red colour in the End of Assay Window indicates that the test is complete.
  • The appearance of the Positive On Board Control (POS CTL √ ) and the Minus Sign (–) gives an extra measure of quality control by demonstrating the functionality of the antibody-colloid complex and capture antibody systems, since they will only appear if the reagents are chemically active. The POS CTL (√ ) and the Minus Sign (–) should always appear for the test to be valid.
  • An additional Negative On Board Control (NEG CTL X) indicates non-specific binding and invalidates the test. 

Features and Benefits

Features

  • Easy to use
    • Assay time - the test tells you when it is ready to read
    • Sample migration – indicated by presence of the Minus Bar
    • Antibody functionality – indicated by presence of the Positive On Board Control
    • Non-specific binding – indicated by presence of the Negative On Board Control
  • Detects hCG in urine to levels of 25mIU/ml
  • Highly specific

Benefits 

  • No training required
  • The test tells you when it is ready to read

          – no need for a timer

  • Rapid results allow immediate follow up
  • Unique in-built controls give complete confidence throughout testing

On-Board Controls

hCG Urine OBC 

TestPack hCG Urine provides the following integral control features: 

minus sign

The Minus Sign
A functional control showing that the sample has run through the test correctly.

Positive control

The Positive Control
Demonstrates the functionality of the antibodies that detect hCG. It will always be produced in a valid test whether or not hCG is present in the sample.

End of Assay

End of Assay
Indicates the test is ready and must be read immediately – no need for a timer

Negative Control

The Negative Control
Indicates a non-specific binding entity in the sample that could cause a false positive result.

Product Specifications

Catalogue no.

505798

Method

Lateral Flow

Time to Result

At appearance of End of Assay (approx. 5 minutes)

Storage

2 - 30oC

Shelf Life

24 months from date of manufacture

Sensitivity

25 mIU/ml

Specificity

100%*

Sample Type

Urine

Kit Size

20 tests

Kit Contents

20 Reaction Discs
20 transfer Pipettes
1 Package Insert

*determined by comparison with a commercially available  hCG test.

Accuracy

In a study, 300 urine specimens collected from women for the purpose of pregnancy testing, were evaluated withTestPack hCG Urine and a commercially available hCG urine test.

Of the 300 urine specimens evaluated, 131 specimens tested positive by both methods and 169 specimens tested negative by both methods. An agreement of 100% (300/300) was determined for these specimens. Therefore the relative sensitivity and relative specificity were found to be 100%.

TestPackhCG Urine

Commercially available hCG test

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Source: Inverness Medical

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