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QUIK-TRAK hCG Test™
For the Rapid Qualitative Determination of Human Chorionic Gonadotropin (hCG) in Urine
One-Step Cassette format with built-in quality control check
Add 3 drops of urine specimen and see results in 3 minutes or less
Sensitive to 20 mIU/mL hCG
Room Temperature Storage
Cat. No. QTCU-25 and QTCU-50
INTENDED USE
The QUIK-TRAK hCG Test™ is for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use.
SUMMARY & PRINCIPAL 1,2
Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone which is secreted by the developing placenta shortly after fertilization. During normal pregnancy, hCG can be detected as early as 6 days following conception, doubling every 1.3 to 2 days. Detection of hCG is an excellent marker for confirming pregnancy.
hCG consists of an alpha and beta sub-unit. The alpha sub-unit is shared by other glycoprotein hormones, e.g., luteinizing hormone (LH), follicle stimulating hormone (FSH), and thyroid stimulating hormone (TSH). the beta sub-units of these molecule differ and confer biological specificity to each. The QUIK-TRAK hCG Test™ detects the intact hCG molecule in urine.
The QUIK-TRAK hCG Test™ is a rapid qualitative immunoassay for the detection of human gonadotropin (hCG) in urine. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by the addition of specimen into the sample well and observing for the formation of colored lines in the result area. The specimen migrates via capillary action along the membrane and reacts with the antibody-dye conjugate. Positive hCG specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Test Zone (T) portion of the membrane. Absence of this colored line suggests a negative result. To serve as a positive procedural control, a colored line in the Control Zone (C) will always appear regardless of the presence or absence of hCG.
PRECAUTIONS
1. For In-vitro Diagnostic Use Only
2. Do not remove test device from the sealed pouch until ready for use.
3. Use appropriate precautions for collection, handling, and storage of specimens.
4. Do not use beyond the expiration date printed on the foil pouch.
REAGENTS
Sealed foil pouch containing one (1) test device comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse IgG antibodies.
STORAGE and STABILITY
Each QUIK-TRAK hCG Test™ is stable until the date printed on the foil pouch when stored unopened at room temperature (59 - 86F or 15 - 30C). Do Not Freeze!
SPECIMEN COLLECTION and PREPARATION 3
Urine specimens must be collected in a clean, dry container, either plastic or glass, without preservatives. Specimens collected at any time may be used; however, the first morning urine generally contains the highest concentration of hCG and is therefore most suitable. If testing is to be delayed more than a few hours, the urine can be stored at 2 - 8C for up to 72 hours or frozen (-20C) for 3 months, but must be brought to room temperature prior to testing. Do Not Use Serum!
Materials Provided:
Materials Required But Not Provided:
TEST PROCEDURE
NOTE: Several test may be run at one time. A new disposable dropper must be used for each specimen.
1. Bring specimen to room remperature before testing.
2. Remove the test device from the sealed pouch and place it on a dry, level surface. Label the device with patient or control identifications.
3. Holding the disposable dropper vertically, dispense 3 drops (approx. 0.12mL) of urine specimen into the sample well (marked "S" on the cassette). Wait for colored lines to appear.
3. Read test results at 3 minutes. Some positive results may be observed in 60 seconds or less depending on the concentration of hCG. Specimens containing levels of hCG below 20mIU/mL may show color development over time but should still be considered negative if the original reading at 3 minutes was negative.
INTERPRETATION of RESULTS
Negative results:
The test is negative if only one colored line appears in the Control Zone. This indicates the absence of detectable levels of hCG.
Positive results:
The test is positive if two colored lines appear. One colored line will appear in the Test Zone (T) and one in the Control Zone(C). This indicates the specimen contains detectable levels of hCG. Any colored line in the Test Zone should be considered positive. Specimens containing levels of hCG below 20 mIU/mL may show color development over time. The colored line in the Control Zone may be lighter or darker in color than the line in the Test Zone.
Invalid results:
The test is invalid if a colored line fails to appear in the Control Zone (C), even if a colored line appears in the Test Zone. If this occurs, add 2 additional drops of specimen and wait 5 minutes. If a colored line still does not appear in the Control Zone, the test is invalid and should be repeated with a new test device.
QUALITY CONTROL
A positive procedural control (Control Zone "C") is built into the QUIK-TRAK hCG Test™ device. The control line will always appear if the test is performed correctly and if the device is working properly. An absence of this control line indicates incorrect procedure or deterioration of reagents. The absence of interfering background is a negative procedural control. If background color appears in the result area which interferes with the ablility to read the test results, the results may be invalid.
If the control line fails to appear with a repeat assay, do not report patient results. Contact Ramco Laboratories Technical Service: (800) 231-6238, (281) 313 -1200, or Fax (281) 313-1251.
EXTERNAL QUALITY CONTROL
Good Laboratory Practice recommends the use of external controls to assure that the reagents and assay are performing correctly. For thiis purpose, we recommend Ramco's Bi-level Controls, Cat. No. 1225-205. Caution: Water (deionized, distilled, or tap) should NOT be used as a negative control. Normal physiological specimens contain the proper amounts of electrolytes and proteins needed to procure the correct results. External controls should be tested with each new lot or shipments or test materials once for each test kit, and as otherwise required by your laboratory's standard GLP quality control procedures.
Process controls as you would a patient sample. A positive result is indicated by the appearance of a colored line in the Test Zone (T), along with a colored line at the Control Zone (C) in the result area. A negative result is indicated by the appearance of only a colored line at the Control Zone in the result area.
LIMITATIONS 4,5,6,7
1. A specimen with a low level of hCG may show color development over time.
2. The contents of this kit are for use in the qualitative detection of hCG.
3. A number of conditions (see Interfering Substances section) other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms, can cause elevated levels of hCG. These diagnoses should be considered if appropriate to clinical evidence.
4. Normal pregnancy cannot be distinguished from an ectopic pregnancy based on hCG levels alone. Spontaneous miscarraige may also cause confusion in interpreting assay results.
5. Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). These specimens may demonstrate either false positive or false negative results when tested with assays which employ mouse monoclonal antibodies.
6. hCG levels may remain detectable for several weeks after normal delivery, delivery by caesarean section, spontaneous abortion, therapeutic abortion or hCG injections.
7. Do not use test devices which have become wet or which have been left out of the foil pouch for more than 24 hours.
8. Positive results from early pregnancy may later prove negative due to natural termination of the pregnancy. This is estimated to occur in 22% of clinically unrecognized pregnancies and 31% of pregnancies overall. It is therefore recommended when using a sesitive hCG assay, such as QUIK-TRAK hCG Test™, that weak positive results be retested 48 - 72 hours later.
9. If a urine specimen is too dilute (i.e. low specific gravity) it may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine should be obtained 48 - 72 hours later and retested.
10. As with all pregnancy tests, the final diagnosis should be based on a correlation of test results with typical clinical signs and symptoms.
EXPECTED VALUES
Urine specimens from healthy men and healthy non-pregnant women do not have hCG levels detectable by the QUIK-TRAK hCG Test™. In normal preganancy, levels of 20 mIU/mL hCG can be reached 2 to 3 days before the first missed menstrual period. hCG levels peak about 8 weeks after the last menstrual period and then decline to lower values during the remainder of the pregnancy. Following delivery, hCG levels rapidly decrease and usually return to normal within days after parturition.
PERFORMANCE CHARACTERISTICS
Accuracy by Comparison: A study was performed using a total of 150 positive and 150 negative urine specimens. These specimens were assayed with the QUIK-TRAK hCG Test™ and the Abbot TestPack Plus urine test according to their package inserts, and yielded 100% correlation.
The accuracy study was also performed by determining the qualitative recovery of known amounts of hCG added to negaitve urine pools. The following concentrations of hCG were added to negative urine pools and yielded 100% correlation to the expected results: O mIU/mL, 20 mIU/mL, 50 mIU/mL and 100 mIU/mL.
Specificity: A study was performed using positive and negative urine specimens spiked with 500 mIU/mL, 1000uIU/mL hTSH, and 1000 mIU/mL hFSH. No cross-reactivity was observed.
Standardization: The QUIK-TRAK hCG Test™ is standaradized in accordance with the WHO 3rd I.S. for human chorionic gonadotropin.
Clinical Studies: An evaluation of the QUIK-TRAK hCG Test™ was conducted at four clinics using patient urine samples. Testing was performed by clinic personnel with diverse educational backgrounds and work experience. The results obtained at each site had 100% agreement with the expected results.
Precision: Within run precision was determined by using 12 replicates of four specimens containing 0, 20, 50, and 100 mIU/mL of hCG. The negative and positive values were correctly identified 100% of the time. Between run precision was determined by using the same four specimens containing 0, 20, 50, and 100 mIU/mL of hCG in 11 different assays, using three different lots of test devices. Again, the negative and positive values were correctly identified 100% of the time.
Sensiitiivity: The QUIK-TRAK hCG Test™ for pregnancy detects hCG concentrations of 20 mIU/mL and greater in urine specimens in accordance with the WHO 3rd I.S. Specimens containing high levels of hCG (1,000,000 mIU/mL), when tested, consistently gave positive results.
INTERFERING SUBSTANCES
High urine hCG levels may occur in patients suffering from chorionic epithelioma or hydatid mole. In these cases a false positive may occur. Excretion of hCG is often decreased in extra uterine pregnancy, toxemia of pregnancy or threatened abortion. Such circumstances can yield false negative results.
Potentially interfering subtances were added to urine which had hCG levels of 0 and 20 mIU/mL. In all cases, no interference with the expected results were observed.
Homologous Hormones:
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hTSH 1000 uIU/mL
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hLH 500mIU/mL
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hFSH 1000mIU/mL
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WHO 68/38
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WHO 2nd IRP HMG
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WHO 2nd IRP HMG
REFERENCES
1. Braunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Am J Obstet Gynecol, 126: 678-681, 1976.
2. Braunstein, G.D., Vaitukaitis, J.L., Carbone, P.P. and Ross, G.T., Ann. Inter. Med., 78, 39-45 (1973).
3. Morgan, F.J., Canfield, R.E., Vaitukaitis, J.L., Carbone, P.P. and Ross, G.T., Endocrinology, 94, 1601-1606 (1974).
4. Koher, G. and Milstein, C., Nature, 256, 495-497 (1975).
5. Thompson, R.J., Jackson, A.P., and Langolis, N., Clin. Chem, 32, 476 -481 (1982).
6. Engavall, E., Methods in Enzymology, 70, 419-439 (1980).
7. Razor, J.L. and Braunstein, G.D., Obstet, Gynecol., 50, 553-558 (1997).
8. Lenton, E.A., Neal, L.M., and Sulaiman, R., Fertility and Sterility, 37, 773-778 (1982).
Ramco Laboratories, Inc.
4100 Greenbriar Dr., Suite #200
Stafford, Texas 77477
800-231-6238 or 281-313-1250
Revised 4/04/05
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