| PRINCIPLE |
Human
Chorionic Gonadotropin (hCG) is secreted
by the developing placenta shortly after
fertilization and can be detected before
the first missed menses. The Sure-Vue™
hCG test is an immunoassay which uses serum
or urine to detect hCG. Specimen is placed
in test sample well. The sample migrates
by capillary action along a membrane which
is impregnated with monoclonal mouse-hCG
specific antibody and colored conjugate.
A positive specimen reacts with the antibody-conjugate
complex and forms a red colored line in
the T (test) window. Absence of this colored
line indicates a negative result. A red
colored line in the C (control) window serves
as a control for the procedure and appears
for all samples.
|
| CLINICAL
UTILITY |
HCG
detection is most often used to confirm
pregnancy.
|
| SPECIMEN |
1.
Type: Urine
2. Sample size: 150 uL. (four drops)
3. Store refrigerated at 2-8°C up to
72 hours or below -20°C for three months.
|
| LIMITATIONS |
1.
Diluted urine specimens with low specific
gravity may not contain enough hCG for detection.
If pregnancy is still suspected, a first
morning specimen should be obtained.
2. A number of conditions other that pregnancy,
including trophoblastic disease and certain
nontrophoblastic neoplasms, cause elevated
levels of hCG. These diagnoses should be
considered if appropriate to the clinical
evidence.
|
| SENSITIVITY |
Sensitivity:
Assay will detect urine hCG concentrations
of 25 mIU/mL or greater.
|
| SPECIFICITY |
Specificity:
100%
|
| COMPUTER
CODES |
Order
Code: PRGU
Workcenter: 262
Testing site: 263
|
| QUALITY
CONTROL |
For
the following locations that obtain hCG packs
directly from Chemical Pathology: MOTT OR,
MAIN OR, ADS, KELLOGG OUTPATIENT SURGERY:
Quality Control is performed by Chemical
Pathology personnel daily
on the packs issued to these units.
|
| PROCEDURE |
Test
kits, specimens, and controls must be at room
temperature prior to testing.
1. Remove test cartridge from pouch. Label
cartridge with sample ID.
2. Dispense 4 drops of specimen (approximately
0.15 mL) into the round sample well. Wait
for colored lines to appear.
3. Read results after 4 minutes and no
later than 30 minutes. Weak positive samples
may take a full 4 minutes to show a line
in the test window. Positive results may
be accepted as soon as control line is visible.
NOTE: If no colored line appears in control
window add two more drops of urine and wait
4 more minutes.
|
| INTERPRETATION
AND REPORTING |
NEGATIVE
The test is negative if a colored line appears
only in the C (control) window.
POSITIVE
The test is positive if a colored line appears
in the T (test) window and a colored line
appears in the C (control) window. Any intensity
colored line in the T (test) window should
be considered positive. Colored lines may
be lighter or darker than each other.
INVALID RESULT
The test is invalid if no colored line appears
in the C (control) window, even if a colored
line appears in the T (test) window.
QUESTIONABLE SPECIMENS
are those which show a barely detectable
verical T (test) line. Report as Questionable
Negative. Recommend repeating pregnancy
test in 48 hours if “Questionable
Negative” or on the first morning
specimen.
|
| MATERIALS
AND REAGENTS |
Sure-Vue™
hCG test kits contain 50 individually sealed
test cartridges with disposable pipets. Test
cartridges contain monoclonal mouse-hCG colored
conjugate and hCG antibody coated on a membrane.
Store test packs at room temperature until
expiration date listed on kits.
|
| REFERENCES |
1.
Schwartz S, Berger P, and Wick G: Epitope-selective
monoclonal antibody based immunoradiometric
assay of predictable specificity for differential
measurement of choriogonadotropin and its
subunits, Clin Chem 31:1322-28, 1985.
2.
Braunstein GD, Rasor J, Adler D, Danzer
H, Wade ME: Serum human chorionic gonadotropin
levels through normal pregnancy. Am J Obstet
Gynecol, 126: 678-681, 1976.
3.
Sure-Vue™ Serum/Urine hCG product
insert., Fisher Scientific Company, April
1999.
|
REVISED
BY |
DATE |
COMMENTS |
| DMH |
11/23/99 |
New
Procedure - Sure-Vue™ Qualitative Serum/Urine
hCG (Replaces Abbott Combo +Plus™) |
| DXT |
12/1/99 |
Modified
Quality Control Section |
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