CLINICAL SIGNIFICANCE/PURPOSE

The QuickVue One-Step 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. hCG is a hormone produced by the placenta shortly after implantation and is an excellent marker for confirming pregnancy.

REAGENTS/SUPPLIES/MATERIALS

  1. Individually wrapped test Cassette
  2. Disposable pipette
  3. Package insert
  4. Watch/clock that measures minutes or timer
  5. Specimen collection container
  6. External positive and negative hCG controls

WARNINGS AND PRECAUTIONS

  1. Kit contents are for in vitro diagnostic use.
  2. Do not use kit contents and controls after expiration date printed on the outside label.
  3. Do not interchange the caps of reagent bottles.
  4. Use appropriate precautions in the collection, handling, and disposal of the specimen and used kit contents.
  5. Standard precautions and guidelines must be followed when performing test.
  6. Dispose of containers and unused contents appropriately. Refer to IC02 – Infection Control General.
  7. To obtain accurate results, you must follow the Package Insert instructions. The Package Insert instructions should be checked with each new lot/shipment for changes in the manufacturer’s instructions.

KIT STORAGE/STABILITY

  1. Store kits and controls at room temperature (59-86̊ F), out of direct sunlight.
  2. Kit contents/controls are stable until the expiration date printed on the outer box carton.

QUALITY CONTROL

  1. Built-in Quality Control Features
  1. 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.
  2. 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 result.
  1. External Quality Control Testing
  1. External controls will be performed with each new lot or shipment of test materials.
  2. Results are recorded on the Urine hCG QC Log.

PATIENT IDENTIFICATION

  1. If performing more than one patient test, test Cassettes must have a patient label affixed to them.
  2. Use a new pipette for each sample/test.

SPECIMEN COLLECTION/STORAGE

  1. For patient testing, collect urine specimen in clean container.
  2. 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.
  3. Urine specimens may be kept at room temperature for 8 hours or refrigerated at 36-46 degrees F for up to 72 hours. Samples may be frozen once at -20 degrees C or below. If frozen, mix after thawing. Do not refreeze.

PROCEDURE

  1. Remove the QuickVue test Cassette from the foil pouch just before use and place it on a clean, dry, level surface.
  2. For patient testing - Using a new, disposable pipette, collect sample and add 3 DROPS of urine to the Round Sample Well on the test Cassette.

For quality control testing – gently mix the hCG Controls by shaking the vials prior to use. Add 3 DROPS of either the Positive or Negative Control to the Round Sample Well on the test Cassette.

  1. Do not handle or move the Cassette until the test is complete and ready for reading.
  2. WAIT THREE MINUTES AND READ.
  3. If the Positive Control was used first for quality control testing, repeat the test with the Negative Control, or vice versa.

INTERPRETATION OF RESULTS

Positive:

Any pink to red Test Line (T) AND a blue Control Line (C) is a positive result for the detection of hCG.

Negative:

A blue Control Line (C) AND NO pink Test Line (T) is a negative result.

Invalid Result:

The test result is invalid if a blue Control Line (C) is not visible in 3 minutes. If this happens, retest using a new sample and new Test Cassette.

LIMITATIONS

  1. The contents of the kit are for us in the qualitative detection of hCG in urine.
  2. Controls should not be diluted and may be incompatible with other assays.
  3. Test results must always be evaluated with other data available to the physician.
  4. 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, including, for example, ectopic pregnancy or molar pregnancy. Patients with trophoblastic and nontrophoblastic disease may have elevated hCG levels, therefore the possibility of hCG secreting neoplasms should be eliminated prior to the diagnosis of pregnancy.
  5. hCG may remain detectable for a few days to several weeks after delivery, abortion, natural termination or hCG injections.
  6. Abnormal pregnancies cannot be diagnosed by qualitative hCG results. The above conditions should be ruled out when diagnosing pregnancy.
  7. 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. Another specimen should be collected after 48 – 72 hours and tested. If waiting for 48 hours is not medically advisable, the test result should be confirmed with a quantitative hCG test.

EXPECTED VALUES

Specimens containing as low as 25 mlU/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, peaking in excess of 100,000 mlU/mL in approximately 10-12 weeks. For some patients, and hCG level of 25 mlU/mL can be detected as early as 2-3 days before expected menses.

REPORTING FORMAT

  1. Record the test result on the Urine hCG Patient Test Log and/or the QC Log as NEG (Negative) or POS (Positive).
  2. If the Built-in Quality Control is present, record as YES.
  3. If the Built-in Quality Control is unacceptable/not present, record as NO (invalid test) and repeat the test using a new test cassette.
  4. Record the test result for patient testing on the Preoperative Assessment form in the patient’s medical record.

COMPETENCY

Competency evaluations will be conducted during new employee orientation and annually thereafter for OISC staff performing testing. Competency records will be maintained in personnel files in the office of the Administrator.

RELATED DOCUMENTATION LOGS

QuickVue Urine hCG Patient Test Log

QuickVue Urine hCG QC Log

REFERENCE

QuickVue One –Step hCG Urine Test package insert, Quidel Corp., San Diego, CA, 06/14.

hCG Control set package insert, Quidel Corp., San Diego, CA, 06/10.

POCT02 – Quidel QuickVue One-Step hCG Urine Test Page 1 of 4