Updated Quidel hCG

2019 Urine hCG Review Guide and Competency

QUIDEL QuickVue ® hCG Urine TEST 

Objectives

At the completion of this course you should be able to do the following:

  • Know how to perform urine hCG testing using the Quidel QuickVue test.
  • Understand the quality control requirements and how to perform external control testing.
  • Explain how to correctly interpret a urine pregnancy result.
  • Discuss the limitations of the test.
  • Understand how to troubleshoot any testing issues.
  • Review and know the location of the Quidel QuickVue One-Step hCG Urine Test policy.

The competency consists of a review and test. The test is located at the end of the review material. 


Intended Use

The Quidel Quickview hCG Urine Test is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. 



Storage and Stability

KitQuickVue testhCG controls

  • Store at room temperature (59°F to 86°F).
  • Store out of direct sunlight.
  • Kit contents are stable until the expiration date printed on outer kit contents.

Controls

  • Store at room temperature (59°F to 86°F).
  • Do not freeze.


Warnings and Precautions

Kit

  • Do not use kit contents after expiration date printed on the outside of the kit.
  • Use appropriate precautions in the collection, storage, handling and disposal of patient samples and used kit contents.
  • Use Standard Precautions when handling patient specimens.
  • Dispose of containers and unused contents according to waste stream policy.
  • To obtain accurate results, you must follow the Package Insert instructions.

Controls

  • DO NOT use beyond the labeled expiration date marked on the outer kit label.
  • DO NOT interchange the caps of any reagent bottles.
  • HANDLE THESE REAGENTS AS IF THEY WERE POTENTIALLY INFECTIOUS.
  • Dispose of containers and unused contents according to waste stream policy.


Quality Control

Built-in Quality Control Features

  • The QuickVue test provides several levels of internal procedural controls with each test run.
    • The appearance of a blue procedural Control Line is an internal positive control. This indicates that sufficient sample fluid was added for capillary flow to occur and the correct procedural technique was used. If this line does not develop, the test result is considered invalid.
    • A clear background in the test result window is an internal background negative control. If the test has been performed correctly, the background should be white to light pink within 3 minutes and not interfere with the reading of the test results.

External Quality Control Testing

  • External controls are used to assure that all reagents and procedures are performing properly.
  • The Positive Control contains purified hCG in a buffered solution.
  • The Negative Control contains no detectable hCG.
  • External controls should be tested with each new lot or shipment of test materials.
  • Assure that the kit lot number has had external controls performed before patient testing.


Specimen Collection and Storage

Collection

  • Collect urine specimens in clean, single use containers.
  • First morning specimens generally contain the highest concentrations of hCG and are recommended for early detection of pregnancy, however any urine specimen is suitable for testing.

Storage

  • Specimens may be kept at room temperature for 8 hours or refrigerated at 36°F to 46°F for up to 72 hours.
  • Samples may be frozen once at -20°C or below. If frozen, mix after thawing. Do not refreeze.


Test Procedure

Patient Testing

If performing more than one patient test, place a patient label on the test Cassette. Use a new Pipette for each sample/test.

  • Collect urine specimen in clean container.
  • Perform hand hygiene and don clean gloves.
  • Check kit expiration date.
  • Remove the QuickVue test Cassette form the foil pouch just before use and place it on a clean, dry, level surface.
  • Using one of the Disposable Pipettes supplied, collect sample and add 3 DROPS of urine to the Round Sample Well on the test Cassette.
  • The test Cassette should not be handled or moved until the test is complete and ready for reading.
  • WAIT 3 MINUTES AND READ. Note: Some positive results may be seen earlier.

Control Testing

  • Perform hand hygiene and don clean gloves.
  • Check kit and control expiration date.
  • Remove test Cassette from the foil pouch just before using and place it on a clean, dry, level surface.
  • Gently mix the hCG Controls by shaking the vials prior to use.
  • Add 3 DROPS of either the Positive or Negative Control to test Cassette sample well. 
  • WAIT 3 MINUTES AND READ.
  • If the Positive Control was used first, repeat the test with the Negative Control or vice versa.


Interpretation of Results

Positive (+):

Any pink-to-red Test Line (T) with a blue Control Line (C) hCG urine test results


Negative (-):

A blue Control Line (C) and no pink Test Line (T)


Invalid Result (∅):

The test result is invalid if a blue Control Line (C) is not visible at 3 minutes. If this happens, retest using a new sample and a new test Cassette or contact Quidel Technical Support.



Limitations

  • The contents of this kit are for use in the qualitative detection of hCG in urine.
  • While pregnancy is the most likely reason for the presence of hCG in urine, elevated hCG concentrations unrelated to pregnancy have been reported in some patients. Conditions other than normal pregnancy may be associated with detectable hCG (i..e, ectopic pregnancy or molar pregnancy).
  • hCG may remain detectable for a few days to several weeks after delivery, abortion, natural termination or hCG injections.
  • Early pregnancy associated with a low level of hCG may show color development after the 3 minute procedure time. If a negative result is obtained but pregnancy is suspected, hCG levels may be too low or urine may be too dilute for detection. The test result should be confirmed with a quantitative hCG test available through the Allina Health laboratory.


Expected Values

  • Specimens containing as low as 25 mIU/mL hCG will yield positive results when tested with the QuickVue test.
  • In normal pregnancy,hCG can be detected as early as 6 days following conception with concentrations doubling every 32-48 hours.
  • For some patients, an hCG level of 25 mIU/mL can be detected as early as 2-3 days before expected menses.


Documentation

  • A patient sticker should be placed on the QuickVue Urine hCG Patient Test Log  with the Test Result, documentation that the Control was present, kit Lot Number and Expiration Date, and initials of individual performing test.
  • On the QuickVue Urine hCG QC Log, the date of testing/date received, initials of individual performing testing, the kit lot number and expiration date, the lot number, expiration date, and result of Positive and Negative Controls should be documented.
  • The results of patient testing should also be documented in the medical record on the Preoperative Nursing Assessment.


Policies

Click on the link below to review the OISC Quidel QuickVue One-Step hCG Urine Test policy. The policy can also be found in the OISC Policy and Procedure Manual located in Phase 1 Recovery.

POCT02 – QuickVue One-Step hCG Urine


Take the following 2019 Urine hCG Competency Test.

You must score 80%. The test can be taken multiple times until this score is reached.

Click the Next button to start the test.