Principle/Policy: | Certification: | Specimen: | Materials: | Reagents: | Standardization: N.A. | Procedure: | Limitations: | Results Derivation: | Expected Result(s) | Quality Control: | References:
The QuickVue Urine hCG test uses a monoclonal antibody specific to the beta subunit of hCG in single-step technology to accurately detect hCG. This test is performed as a definitive function. Results of the test could trigger therapeutic interaction without reflex laboratory analysis.
Urine is added to the Sample Well on the Test Cassette. If hCG is present in the specimen at a level of 25 mIU/ml or greater, a pink-to-red Test (T) Line will appear along with a blue procedural Control (C) Line in the Result Window. If hCG is present at very low levels, or not present in the specimen, only a blue procedural Control Line will appear in the Result Window.
1. Orientation, authorization and competency of staff and licensed practitioners performing POCT are provided by the director’s (named on the CLIA certificate) designee as indicated in the “Point of Care (POCT) Program” procedure.
2. hCG testing will be performed by Nursing Service personnel who have been specifically certified:
A. To be certified, the requirements of the hCG Urine; QuickVue; POCT Self-Instructional/Competency documentation packet must be completed.
B. If the individual seeking certification is unable to demonstrate acceptable performance of Quality Control, he/she must be retrained and successfully re-tested for authorization to perform hCG testing.
C. Re-certification is required annually:
a. Re-certification for an individual may be required more often if deemed necessary. When an instructor observes improper technique, he/she may decertify the operator on the spot. Arrangements for re-certification of that individual must then be made through their immediate supervisor.
b. To be re-certified, an operator must successfully complete the hCG Urine; QuickVue; POCT Self-Instructional/Competency documentation packet.
D. This test requires blue-spectrum differentiation and should not be attempted by individuals with blue colorblindness. Colorblindness testing will be performed during test certification, if it has not already been done. Record on Competency documentation sheet the date that the colorblindness test was performed and the result of the test. If you have not been tested for colorblindness, contact Employee Health Services before proceeding.
4. The certification records of operators and instructors are reviewed by the Clinical Educators for the department, or the department supervisor and will be maintained on site.
5. MMC: Emergency & Ambulatory Departments: The Quick-Vue Urine hCG Log is reviewed by the department Supervisor monthly. The logs are then sent to the UCL Office of the Technical Director quarterly for review. Logs will be returned to the department for storage.
6. Physicians performing waived testing are exempt from training and competency documentation.
1 ml of urine collected into a clean, dry, plastic or glass container is acceptable but first voided, morning specimens are usually the best because they typically contain the highest concentration of hCG. Bloody urine specimens and specimens exhibiting visible precipitates should be centrifuged and the supernatant used for testing. Specimens must be at room temperature prior to testing. Specimens must be gently mixed prior to testing.
Note: A 70 ml urine specimen will take about 1½ hr to reach room temperature from chilled 8°C.
Note: Urine that is red in color may prevent the accurate reading of test results by masking the positive line.
QuickVue® Urine hCG kit (CardinalHealth #B6775-50)
The test kit is to be stored at room temperature (15 - 30°C), out of direct sunlight. Stable until the expiration date listed on the box.
Urine hCG controls (CardinalHealth #B6775-14)
Store controls at room temperature. Allow controls to reach room temperature prior to testing.
Stable until the expiration date listed on the box.
The person who sets up the test must also read the test and report results.
1. Remove a QuickVue Test Cassette from the foil pouch just before use and place it on a clean, dry, level surface.
2. Label the cassette with patient name or control identifiers.
3. Using a transfer pipette supplied with the kit, dispense three (3) drops of urine specimen, or using the control dropper bottles dispense three (3) drops of control, into 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.
Note: A new transfer pipette is used for each specimen and control.
4. Set a timer for 3 minutes.
5. Urine specimens: Read result at 3 minutes. Results read after 3 minutes are to be considered invalid and the test must be re-run. This should be noted in the test log.
6. Record the results on the Urine hCG QuickVue Test log.
Conditions other than normal pregnancy may be associated with detectable hCG, including for example, ectopic pregnancy or molar pregnancy. Patients with trophoblastic and non trophoblastic disease may have elevated hCG levels, therefore, the possibility of hCG secreting neoplasms should be eliminated prior to the diagnosis of pregnancy.
1. Positive results:
The test is positive if one red colored line appears in the T (test) region and one blue colored line appears in the C (control) region.
Note: The line in the T (test) region may be lighter, darker or the same intensity as the line in the C (control) region.
2. Negative results:
The test is negative if a blue colored line appears only in the C (control) region.
3. Equivocal results:
If uncertain whether even a faint strip of color has developed in the T (test) region, don’t attempt to decide by committee. Call the test "Equivocal" and suggest retest on a follow-up sample.
“Expected” or “normal” results are completely dependent upon the clinical circumstances. Healthy males should be “negative”.
1. Endogenous Control:
Described in the test procedure above, is a function check endogenous to the analytical system, which provides effective, real time, quality control on a unit use basis. For every single analysis, Testing Personnel will verify with a check mark in the space provided on the requisition that the blue colored line appeared in the C (control) region of the device and the background was clear.
A. Internal Positive Control:
The appearance of a blue Control Line in the C region of the device is a positive procedural control. Correct procedural technique, specimen flow and device performance are confirmed when a blue colored line appears in the C (control) region of the membrane. If the blue colored line fails to appear in the C (control) region, the test result is invalid.
B. Internal Negative Control:
A clear background is an internal negative procedural control. The background color should be white to light pink and should not interfere with the reading of the test result. If a more intensely red background color appears, it may interfere with the ability to read the test result, therefore the test should be repeated.
C. If the endogenous control fails, do NOT report the patient result!
The specific failure will be documented by leaving the appropriate check box on the Log blank or empty.
Notify the Site Supervisor or the UCL Technical Director. Indicate in the designated Urine hCG QuickVue Test log who was contacted along with the date and time of the contact.
2. Exogenous Controls:
A. CMS “Waived” status.
B. Nursing personnel authorized to perform the testing will run the positive and negative urine hCG controls on a rotational basis for each lot number of each shipment received regardless of whether the lot number has changed. Nursing Service or the Site Supervisor will ensure that those individuals who are authorized to perform the test run the assigned controls on a rotational basis.
C. These control trials must generate the expected reaction response. Record results on the Urine hCG QuickVue Test log.
D. If a control fails to generate the expected reaction response, do not use the kit; complete the following procedure:
a. Repeat the Q.C. test.
b. Document the failed test result and repeat test on the designated laboratory test log. Notify the Site Supervisor and the office of the UCL Technical Director immediately.
c. Indicate in the designated Urine hCG QuickVue Test log who was contacted along with the date and time of the contact.
3. When a new kit is opened, record the lot number in the designated laboratory test log. Check the new kit lot # against the previous lot #. Indicate on the log if the lot # is the same as the current lot or if it is a new lot #.
1. Susie McBeth, JCAHO regional agent, JCAHO Division of Research. Oakbrook Terrace, IL 60181; (630) 792-5000 4/9/2001.
2. Sure-Vue® Serum/Urine hCG Package Insert. Fisher Scientific Co. Houston, TX. 3/03
3. QuickVue One-Step hCG Combo test package insert. Quidel Corporation. San Diego, CA.
i. June 2003 L. McGovern (Revised: III.1.2nd Note, VII.5, VIII., IX.4.B., XI., XII.6.)
ii. February 2004 L. McGovern (Revised for QuickVue hCG)
iii. June 2004 S. Raymond/L. McGovern (Revised: language/protocol updated for CMS status)
iv. February 2007 L. McGovern (Revised: I.; XI.2.B.)
v. October 2009 L. McGovern, S. Raymond (Revised: II.1. added)
Medical Director; P.A.:
Technical Director; P.A.:
Representative: Nursing Service Mercy
Representative: Crescent Com. Health Ctr.
Representative: Cascade Medical Ctr.
January 2011 L. McGovern (Revised: II.5.; VII.3.; XI.2.B.)
January 2012 S. Jaeger (Revised: XII.; rev history)