Download Urine hCG Pregnancy Test

Page 1 of 4
Title: Manual Urine Pregnancy Screen Testing
Manual: Point of Care Testing
Section: General
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3010
Date Issued: March 2001
Purpose
This is a Point of Care Test (POC) and falls under the Ministry of Health and Long-Term Care Testing
Policy for Hospitals and Other Facilities. This policy states, “Under current legislation, only
physicians can authorize point of care testing. In these circumstances, the ordering physician
must take responsibility for the tests performance and the test results produced.” Physicians
can either perform the test themselves or have a properly trained Registered Nurse perform the test in
accordance with the following procedure.
Quality Assurance

A quality assurance program will be maintained for this test according to the guidelines set
forth in the Quality Assurance; Point of Care Testing Policy.
Principle




Solid phase, sandwich format immunochromatographic assay.
HCG in sample binds to a monoclonal anti-hCG dye conjugate.
hCG-anti-hCG dye conjugate is captured using an immobilized polyclonal anti-hCG.
Excess anti-hCG dye conjugate is captured using an immobilized antibody to the anti-hCG
dye conjugate.
Specimen
PATIENT PREPARATION:
No special patient preparation is necessary.
TYPE:
 Random urine, first morning is best
 Urines with low specific gravity may yield false negative results.
HANDLING CONDITIONS:
 Store urine specimens at room temperature up to 8 hours, or at 2 -8C up to 72 hours.
 Bring samples to room temperature before testing.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 2 of 4
Title: Manual Urine Pregnancy Screen Testing
Manual: Point of Care Testing
Section: General
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3010
Date Issued: March 2001
Material:
 hCG urine/serum test devices – Nova Century Scientific Catalog Number: FHC-202 (Box of 40
devices)
 pipette (included with each test kit)
 timer
 sample collection containers
Testing devices are to be ordered directly from the Brantford General Laboratory, 751-5544 ext.
2448. The laboratory will Quality Control the box prior to sending to Day Surgery
PREPARATION:
 Test device must be at room temperature before using.
 Use test device as soon as possible after opening, no longer than 1 hour.
STORAGE REQUIREMENTS:
 Test devices are stored at room temperature, out of direct sunlight.
 Test devices can also be stored at 4 - 8C, but brought to room temperature before use.
 Test devices are stable to the expiry date printed on the foil pouches.
 Do not freeze.
Calibration

None required
Quality Control Material
INTERNAL
The labeled antibody conjugate is captured in both the test and control bands. The presence of the
control band in the results window is an internal positive quality control which validates the
proper function of the test system, the environment and the operator.
The appearance of the control band assures proper function of the detection component and
adequate capillary migration of the sample.
The appearance of the control band assures proper storage and handling of the test device.
The appearance of the control band assures an adequate amount of fluid was added to the test
device.
The clearing background acts as a negative control as it should appear white to light grey and not
interfere with the reading of results
The Internal Quality Control Band (IQC) must be documented with every test result on the patient’s
chart.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 3 of 4
Title: Manual Urine Pregnancy Screen Testing
Manual: Point of Care Testing
Section: General
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3010
Date Issued: March 2001
ADDITIONAL QUALITY CONTROL:
 Additional QC (Positive and Negative) is to be run on each new lot number and/or shipment and
Documented in Meditech by BCHS lab
Procedure
1.
Test must be ordered by a physician and performed by a properly trained physician or
registered nurse.
2.
Remove test device and transfer pipette from foil pouch and place on a flat surface.
3.
Verify the patients name to be tested and that the urine is properly labeled. Record the
name on the testing device.
4.
Using transfer pipette, squeeze bulb and aspirate specimen.
5.
Dispense three full drops (~100ul) into the sample well of the test device.
6.
Set a timer and read the results in 3 minutes for urine. Do not interpret results after 10
minutes.
Positive
- Two red bands; one at T (test) and one at C (control)
Negative
- one band only at the C (control)
Inconclusive - two red bands with the T (test) being very faint – Send serum to Lab for STAT
quantitative Serum Pregnancy test
Test is invalid and must be repeated if no red band is seen in the Control Position. Do
not report results if test is invalid.
Contact the BGH Laboratory if problems with invalid tests are encountered.
 Urine should be stored at 2-8ºC for 24 hours before discarding to allow for confirmation testing if
required.
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled
Page 4 of 4
Title: Manual Urine Pregnancy Screen Testing
Manual: Point of Care Testing
Section: General
Document Number:
Issuing Authority: Medical Director, Laboratory Services
POCT.GEN.3010
Date Issued: March 2001
Reporting Results
REPORTING FORMAT:
 If the test meets the QC criteria the results are reported as Positive or Negative.
 If the band in the test area is very faint result as Inconclusive
 Do not report invalid tests.
 The Internal QC must be checked and documented with the test result..
Results will be reported and transmitted to the patient’s electronic medical record via glucose meter
1. Power on the meter
2. Scan your Id barcode
3. From the Main Menu screen touch Patient Test.
4. From the Patient Test Menu touch Other Test.
5. Touch Pregnancy.
6. Select the desired test from the display list.
7. Scan the Patient ID
8. Touch √ to enter the current date and proceed to the next screen.
9. Touch √ to enter the current time and proceed to the next screen
10. Select the result of the Internal Control as acceptable or not acceptable by touching the
appropriate button.
11. Select the patient test result as positive or negative or inconclusive by touching the appropriate
button.
12. Touch √ to validate results
13. Results will post in the EMR
Limitations of the Procedure
 Dilute urines (low specific gravity) may not have representative levels of hCG.
 False negative results may occur if levels of hCG are below the sensitivity of the test (25
mIU/ml).
References
 n.c.s hCG Method Insert; Catalog Number; FHC-202
 NCCLS; GP2-A2; Clinical Laboratory Technical Procedure Manuals-2nd Edition
DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS
intranet site. Any documents appearing in paper form are NOT controlled