AccuBiotech Co., Ltd.
Accurate, Reliable, Cost Effective
ACCU-TELL® 1. For professional in vitro diagnostic use only. Do not use after
the expiration date.
HCG Cassette (Urine) 2. The test should remain in the sealed pouch until ready to use.
For in vitro diagnostic Use only 3. All specimens should be considered potentially hazardous and
handled in the same manner as an infections agent.
4. The used test should be discarded according to local
For Urine Samples regulations.
This package insert is applied to the below products: STORAGE AND STABILITY
Store as packaged at room temperature or refrigerated (2-30°C).
Catalog No. Product Name
The test is stable through the expiration date printed on the sealed
ABT-FT-B1 HCG Cassette (Urine)
pouch or label of the closed canister. The test must remain in the
sealed pouch or closed canister until use. DO NOT FREEZE. Do
A rapid test for the qualitative detection of human chorionic not use beyond the expiration date.
gonadotropin (hCG) in urine.
For professional in vitro diagnostic use only SPECIMEN COLLECTION AND PREPARATION
Urine Assay
INTENDED USE A urine specimen must be collected in a clean and dry container. A
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ACCU-TELL HCG Cassette (Urine) is a rapid chromatographic first morning urine specimen is preferred since it generally contains
immunoassay for the qualitative detection of human chorionic the highest concentration of hCG; however, urine specimens
gonadotropin in urine to aid in the early detection of pregnancy. collected at any time of the day may be used. Urine specimens
exhibiting visible precipitates should be centrifuged, filtered, or
SUMMARY allowed to settle to obtain a clear specimen for testing.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone Specimen Storage
produced by the developing placenta shortly after fertilization. In Urine specimens may be stored at 2-8℃ for up to 48 hours prior to
normal pregnancy, hCG can be detected in both urine and serum testing. For prolonged storage, specimens may be frozen and
1,2,3,4
or plasma as early as 7 to 10 days after conception. hCG stored below -20℃. Frozen specimens should be thawed and
levels continue to rise very rapidly, frequently exceeding mixed before testing.
2,3,4
100mIU/mL by the first missed menstrual period, and peaking in
the 100,000-200,000mIU/mL range about 10-12 weeks into MATERIALS
pregnancy. The appearance of hCG in both the urine and serum or Materials provided
plasma soon after conception, and its subsequent rapid rise in Test cassettes
concentration during early gestational growth, make it an excellent Package insert
marker for the early detection of pregnancy. Materials required but not provided
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ACCU-TELL HCG Cassette (Urine) is a rapid test that qualitatively Specimen collection containers
detects the presence of hCG in urine specimen at the sensitivity of Timer
25mIU/mL. The test utilizes a combination of monoclonal and
polyclonal antibodies to selectively detect elevated levels of hCG in TEST PROCEDURE
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urine. At the level of claimed sensitivity, ACCU-TELL HCG 1. Bring the pouch to room temperature (15-30℃) before opening
Cassette (Urine) shows no cross-reactivity interference from the it. Remove the cassette from the sealed pouch and use it as
structurally related glycoprotein hormones hFSH, hLH and hTSH at soon as possible.
high physiological levels. 2. Place the cassette on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approximately
PRINCIPLE 120ul) to the specimen well of the cassette, and then start the
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ACCU-TELL HCG Cassette (Urine) is a rapid chromatographic timer. Avoid trapping air bubbles in the specimen well. See
immunoassay for the qualitative detection of human chorionic illustration below.
gonadotropin in urine to aid in the early detection of pregnancy. 3. Wait for the colored line(s) to appear. The result should be read
The test uses two lines to indicate results. The test utilizes a at 3 minutes.
combination of antibodies including a monoclonal hCG antibody to NOTE: A low hCG concentration might result in a weak line
selectively detect elevated levels of hCG. The control line is appearing in the test line region (T) after an extended period of
composed of goat polyclonal antibodies and colloidal gold particles. time; therefore, do not interpret the result after 10 minutes.
The assay is conducted by immersing the test cassette in a urine
specimen and observing the formation of colored lines. The
specimen migrates via capillary action along the membrane to
react with the colored conjugate. Positive specimens react with the
specific antibody-hCG-colored conjugate to form a colored line at
the test line region of the membrane. Absence of this colored line
suggests a negative result. To serve as a procedural control, a
colored line will always appear in the control line region indicating
that proper volume of specimen has been added and membrane
wicking has occurred.
INTERPRETATION OF RESULTS
REAGENTS (Please refer to the illustration above)
The test contains anti-hCG particles and anti-hCG coated on the POSITIVE: Two distinct colored lines appear. One line should
membrane. be in the control line region(C) and another line should be in the
test line region (T). One line may be lighter than the other; they do
PRECAUTIONS not have to match. This means that you are probably pregnant.
Please read all the information in this package insert before NEGATIVE: One colored line appears in the control line region
performing the test. (C). No line appears in the test line region (T). This means that you
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ACCU-TELL HCG Cassette (Urine) Effective Date: 2018-02
AccuBiotech Co., Ltd. Accurate, Reliable, Cost Effective
are probably not pregnant. Other hCG Rapid
INVALID: The result is invalid if no colored line appears in the Method
Test Total Results
control line region (C), even if a line appears in the test line ACCU- Results Positive Negative
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region (T). You should repeat the test with a new test cassette. TELL HCG Positive 117 0 117
Cassette
QUALITY CONTROL Negative 0 296 296
(Urine)
A procedural control is included in the test. A colored line appearing Total Results 117 296 413
in the control line region (C) is considered an internal procedural
Sensitivity: ＞99.9% (97.5%~100%)*
control. It confirms sufficient specimen volume, adequate
membrane wicking. A clear background is an internal negative Specificity: ＞99.9%(99.0%~100%)*
procedural control. If a background color appears in the result
Accuracy: ＞99.9 %( 99.3%~100%) *
window and interferes with the ability to read the test result, the
result may be invalid. It is recommended that a positive hCG * 95% Confidence Intervals
control (containing 25-250mIU/mL hCG) and a negative hCG
control (containing "0"mIU/mL hCG) be evaluated to verify proper Sensitivity and Cross-Reactivity
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test performance when a new shipment of tests is received. ACCU-TELL HCG Cassette (Urine) detects hCG at a
concentration of 25mIU/mL or greater. The test has been
LIMITATIONS standardized to the W.H.O. International Standard. The addition of
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1. ACCU-TELL HCG Cassette (Urine) is a preliminary qualitative LH (300mIU/mL), FSH (1,000mIU/mL), and TSH (1,000μIU/mL) to
test, therefore, neither the quantitative value nor the rate of negative (0mIU/mL hCG) and positive (25mIU/mL hCG) specimens
increase in hCG can be determined by this test. showed no cross-reactivity.
2. Very dilute urine specimens, as indicated by a low specific Precision
gravity, may not contain representative levels of hCG. If Intra-Assay
pregnancy is still suspected, a first morning urine specimen Within-run precision has been determined by using 10 replicates of
should be collected 48 hours later and tested. three specimens containing 25mIU/ml, 100mIU/ml, 250mIU/ml and
3. Very low levels of hCG (less than 50mIU/mL) are present in 0mIU/ml of HCG. The negative and positive values were correctly
urine specimens shortly after implantation. However, because a identified 100% of the time.
significant number of first trimester pregnancies terminate for Inter-Assay
5
natural reasons, a test result that is weakly positive should be Between-run precision has been determined by using the same
confirmed by retesting with a first morning urine specimen three specimens of 25mIU/ml, 100mIU/ml, 250mIU/ml and
collected 48 hours later. 0mIU/ml of HCG in 10 independent assays. Three different lots of
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4. This test may produce false positive results. A number of ACCU-TELL HCG Cassette (Urine) have been tested. The
conditions other than pregnancy, including trophoblastic disease specimens were correctly identified 100% of the time.
and certain non-trophoblastic neoplasms including testicular Interfering Substance
tumors, prostate cancer, breast cancer, and lung cancer, cause The following potentially interfering substances were added to
6,7
elevated levels of hCG. Therefore, the presence of hCG in hCG negative and positive specimens.
urine should not be used to diagnose pregnancy unless these Acetaminophen 20 mg/dL Caffeine 20 mg/dL
conditions have been ruled out. Acetylsalicylic Acid 20 mg/dL Gentisic Acid 20 mg/dL
5. This test may produce false negative results. False negative Ascorbic Acid 20 mg/dL Glucose 2 g/dL
results may occur when the levels of hCG are below the Atropine 20 mg/dL Hemoglobin 1 mg/dL
sensitivity level of the test. When pregnancy is still suspected, a Bilirubin 2 mg/dL
first morning urine specimen should be collected 48 hours later None of the substances at the concentration tested interfered in
and tested. In case pregnancy is suspected and the test the assay.
continues to produce negative results, see a physician for further
diagnosis. BIBLIOGRAPHY
6. This test provides a presumptive diagnosis for pregnancy. A 1. Batzer FR. Hormonal evaluation of early pregnancy, Fertil.
confirmed pregnancy diagnosis should only be made by a Steril. 1980; 34(1): 1-13
physician after all clinical and laboratory findings have been 2. Catt KJ, ML Dufau, JL Vaitukaitis Appearance of hCG in
evaluated. pregnancy plasma following the initiation of implantation of the
blastocyte, J. Clin. Endocrinol. Metab. 1975; 40(3): 537-540
EXPECT VALUE 3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade Serum
Negative results are expected in healthy non-pregnant women and human chorionic gonadotropin levels throughout normal
healthy men. Healthy pregnant women have hCG present in their pregnancy, Am. J. Obstet. Gynecol. 1976; 126(6): 678-681
urine and serum specimens. The amount of hCG will vary greatly 4. Lenton EA, LM Neal, R Sulaiman Plasma concentration of
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with gestational age and between individuals. ACCU-TELL HCG human chorionic gonadotropin from the time of implantation until
Cassette (Urine) for Urine has a sensitivity of 25mIU/mL, and is the second week of pregnancy, Fertil. Steril. 1982; 37(6): 773-
capable of detecting pregnancy as early as 1 day after the first 778
missed menses. 5. Steier JA, P Bergsjo, OL Myking Human chorionic
gonadotropin in maternal plasma after induced abortion,
PERFORMANCE CHARACTERISTICS spontaneous abortion and removed ectopic pregnancy, Obstet.
Accuracy Gynecol. 1984; 64(3): 391-394
A multi-center clinical evaluation was conducted comparing the 6. Dawood MY, BB Saxena, R Landesman Human chorionic
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results obtained using ACCU-TELL HCG Cassette (Urine) to gonadotropin and its subunits in hydatidiform mole and
another commercially available urine hCG Rapid test. The study choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181
included 413 urine specimens, and both assays identified 296 7. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross Ectopic
negative and 117positive results. The results demonstrated >99% production of human chorionic gonadotropin by neoplasms, Ann.
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overall accuracy of ACCU-TELL HCG Cassette (Urine) when Intern Med. 1973; 78(1): 39-45
compared to the other hCG Rapid Test.
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ACCU-TELL HCG Cassette (Urine) Effective Date: 2018-02
AccuBiotech Co., Ltd. Accurate, Reliable, Cost Effective
GLOSSARY OF SYMBOLS
Temperature
Catalog number
limitation
Consult instructions
Batch code
for use
In vitro diagnostic
Use by
medical device
Manufacturer Do not reuse
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ACCU-TELL HCG Cassette (Urine) Effective Date: 2018-02
