 MATERIALS the maximum line (MAX) on the test strip when immersing

MATERIALS PROVIDED the strip. See the illustration below.

 Test strips(contains anti-hCG particles and anti-hCG coated on 3. Place the test strip on a non-absorbent flat surface, start
the membrane). the timer and wait for the red line(s) to appear.
 Package insert 4. Read the result at 3 minutes when testing a urine specimen,
MATERIALS NEEDED BUT NOT PROVIDED or at 5 minutes when testing a serum specimen.
One Step Pregnancy Test Strip  Specimen collection container 5. It is important that the background is clear before the result
(Urine/Serum)  Timer is read.
A rapid, one step test for the qualitative detection of human NOTE
chorionic gonadotropin (hCG) in urine or serum. PRECAUTIONS A low hCG concentration might result in a weak line appearing in the
 For professional and in vitro diagnostic use only. Do not use test region (T) after an extended period of time; therefore, do not
For In-Vitro diagnostic and professional use only after the expiration date. interpret the result after 10 minutes.
 The test strip should remain in the closed pouch until use.
 All specimens should be considered potentially hazardous INTERPRETATION OF RESULTS
Store at 2-30°C. and handled in the same manner as an infectious agent. (Please refer to the illustration below)
 The test strip should be discarded in a proper biohazard POSITIVE: Two distinct red lines appear. One line should be in the control
INTENDED USE container after testing. region (C) and another line should be in the test region (T).
Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) is a rapid NEGATIVE: One red line appears in the control region (C). No apparent
chromatographic immunoassay for the qualitative detection of human STORAGE AND STABILITY red or pink line appears in the test region.
chorionic gonadotropin (hCG) in urine or serum to aid in the early  Store as packaged in the closed pouch at 2-30°C. INVALID: Control line fails to appear. Insufficient specimen volume or
detection of pregnancy.  The test strip is stable through the expiration date printed on the incorrect procedural techniques are the most likely reasons for
sealed pouch. control line failure. Review the procedure and repeat the test with a
INTRODUCTION new test strip. If the problem persists, discontinue using the test kit
 The test strip must remain in the closed pouch until use.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced immediately and contact your local distributor.
 Do not freeze.
by the developing placenta shortly after fertilization. In normal pregnancy, NOTE:
 Do not use beyond the expiration date.
hCG can be detected in both urine and serum as early as 7 to 10 days after The intensity of the red color in the test line region (T) will vary depending
conception .hCG levels continue to rise very rapidly, frequently exceeding on the concentration of hCG present in the specimen. However, neither
100 mIU/ml by the first missed menstrual period, and peaking in the SPECIMEN COLLECTION AND PREPARATION the quantitative value nor the rate of increase in hCG can be determined
100,000-200,000 mIU/ml range about 10-12 weeks into pregnancy. The Urine Assay by this qualitative test.
appearance of hCG in both urine and serum soon after conception, and its A urine specimen must be collected in a clean and dry container. A first
subsequent rapid rise in concentration during early gestational growth, morning urine specimen is preferred since it generally contains the
make it an excellent marker for the early detection of pregnancy. highest concentration of hCG; however, urine specimens collected at any
Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) is a rapid test that time of the day may be used. Urine specimens exhibiting visible
qualitatively detects the presence of hCG in urine or serum specimen at precipitates should be centrifuged, filtered, or allowed to settle to obtain
the sensitivity of 25 mIU/mL. The test utilizes a combination of a clear specimen for testing.
monoclonal and polyclonal antibodies to selectively detect elevated levels
of hCG in urine or serum. At the level of claimed sensitivity, Atlas hCG One Serum Assay
Step Pregnancy Test Strip (Urine/Serum) shows no cross-reactivity Blood should be collected aseptically into a clean tube without
interference from the structurally related glycoprotein hormones FSH, LH anticoagulants. Separate the serum from blood as soon as possible to
and TSH at high physiological levels. avoid hemolysis. Use clear non-hemolyzed specimens when possible.
Specimen Storage
PRINCIPLE Urine or serum specimen may be stored at 2-8°C for up to 48 hours prior
Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) is a rapid to testing. For prolonged storage, specimens may be frozen and stored EXPECTED VALUES
chromatographic immunoassay for the qualitative detection of human below -20°C. Frozen specimens should be thawed and mixed before  Negative results are expected in healthy non-pregnant women
chorionic gonadotropin (hCG) in urine or serum to aid in the early detection testing. and healthy men. Healthy pregnant women have hCG present
of pregnancy. The test utilizes a combination of antibodies including a in their urine and serum specimens. The amount of hCG will
monoclonal hCG antibody to selectively detect elevated levels of hCG. The PROCEDURES FOR USE vary greatly with gestational age and between individuals.
assay is conducted by immersing the test strip in a urine or serum specimen Allow the test strip, urine or serum specimen and/or controls to  Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) has a
and observing the formation of colored lines. The specimen migrates via equilibrate to room temperature (15-30°C) prior to testing. sensitivity of 25 mIU/mL, and is capable of detecting pregnancy
capillary action along the membrane to react with the colored conjugate. as early as 1 day after the first missed menses.
Positive specimens react with the specific antibody-hCG-colored conjugate 1. Bring the pouch to room temperature before opening it.
and form a colored line at the test line region of the membrane. Absence of Remove the test strip from the sealed pouch and use it as
QUALITY CONTROL
this colored line suggests a negative result. To serve as a procedural control, soon as possible.
 A procedural control is included in the test. A red line
a colored line will always appear at the control line region if the test has 2. With arrows pointing toward the urine or serum specimen,
appearing in the control region (C) is the internal procedural
been performed properly. immerse the test strip vertically in the urine or serum
control. It confirms sufficient specimen volume and correct
specimen until the sample starts to migrate. Do not pass
procedural technique. A clear background is also required.
  It is recommended that a positive hCG control (containing hCG) and positive (25 mIU/ml hCG) specimens showed no cross-reactivity. ATLAS MEDICAL
25-250 mIU/mL hCG) and a negative hCG control (containing Unit 4, William James House
"0" mIU/mL hCG) be evaluated to verify proper test INTERFERING SUBSTANCES Cowley Rd, Cambridge, CB4 0WX
performance when a new shipment of test devices are The following potentially interfering substances were added to hCG negative Tel: ++44 (0) 1223 858 910
received. and positive specimens. Fax: ++44 (0) 1223 858 524
SUBSTANCE CONCENTRATION
LIMITATIONS Acetaminophen 20 mg/ml
 Very dilute urine specimens, as indicated by a low specific PPI017A01
gravity, may not contain representative levels of hCG. If Acetylsalicylic Acid 20 mg/ml Rev C (08.10.2015)
pregnancy is still suspected, a first morning urine specimen Ascorbic Acid 20 mg/mL
should be collected 48 hours later and tested.
Atropine 20 mg/mL
 False negative results may occur when the levels of hCG are
Bilirubin (serum) Bilirubin 40 mg/dL
Product Single use.
below the sensitivity level of the test. When pregnancy is still
suspected, a first morning urine or serum specimen should be (urine) 2 mg/dL Reference No. Do not re-use.
collected 48 hours later and tested. Caffeine 20 mg/mL Do not use if
For in-vitro
 Very low levels of hCG (less than 50 mIU/mL) are present in Gentisic Acid 20 mg/mL the pouch is
urine or serum specimen shortly after implantation. However, diagnostic use.
Glucose 2 g/dL damaged.
because a significant number of first trimester pregnancies
For Self-Testing
terminate for natural reasons, a test result that is weakly Hemoglobin 1 mg/dL Store at
positive should be confirmed by retesting with a first morning use.
Triglycerides (serum) 1200 mg/dL
urine or serum specimen collected 48 hours later. Number of tests
Caution.
 A number of conditions other than pregnancy, including in the pack.
trophoblastic disease and certain non-trophoblastic neoplasms None of the substances at the concentration tested interfered in the assay.
Read product
including testicular tumors, prostate cancer, breast cancer, and
REFERENCES insert before Manufacturer.
lung cancer, cause elevated levels of hCG. Therefore, the
presence of hCG in urine or serum specimen should not be 1. Batzer FR. “Hormonal evaluation of early pregnancy”, Fertil. use.
used to diagnose pregnancy unless these conditions have been Steril. 1980; 34(1): 1-13 Lot (batch)
Expiry date.
ruled out. 2. Catt KJ, ML Dufau, JL Vaitukaitis “Appearance of hCG in pregnancy number.
 This test provides a presumptive diagnosis for pregnancy. A plasma following the initiation of implantation of the blastocyte”, J. Manufacturer
confirmed pregnancy diagnosis should only be made by a Clin. Endocrinol. Metab. 1975; 40(3): 537-540 Manufacturer fax
telephone
physician after all clinical and laboratory findings have been 3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade “Serum human number.
number.
evaluated. chorionic gonadotropin levels throughout normal pregnancy”, Am. J.
 False Negative results may occur to samples of women who are [Link]. 1976; 126(6): 678-681
pregnant for more than 5 weeks. This is due to excess hCG 4. Lenton EA, LM Neal, R Sulaiman “Plasma concentration of
variants in the urine that had been noticed in some uncommon human chorionic gonadotropin from the time of implantation
cases of 10 weeks of pregnancy . If such cases are suspected , a until the second week of pregnancy”, Fertil. Steril. 1982; 37(6):
dilution of 1:10 of the samples need to be retested to confirm 773-778
the negative results. 5. Steier JA, P Bergsjo, OL Myking “Human chorionic
gonadotropin in maternal plasma after induced abortion,
PERFORMANCE CHARACTERISTICS spontaneous abortion and removed ectopic pregnancy”,
Accuracy Obstet. Gynecol. 1984; 64(3): 391-394
A multi-center clinical evaluation was conducted comparing the results 6. Dawood MY, BB Saxena, R Landesman “Human chorionic
obtained using Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) gonadotropin and its subunits in hydatidiform mole and
to another commercially available urine/serum membrane hCG test. The choriocarcinoma”, Obstet. Gynecol. 1977; 50(2): 172-181
urine study included 155 specimens and both assay identified 76 negative
and 79 positive results. The serum study included 57 specimens and both
assays identified 38 negative and 19 positive results. The results
demonstrated a 100% overall agreement (for an accuracy of > 99%) of
Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) in comparison
to the other serum/urine membrane hCG test.

SENSITIVITY AND SPECIFICITY

Atlas hCG One Step Pregnancy Test Strip (Urine/Serum) detects hCG at a
concentration of 25 mIU/ml or greater. The test has been standardized to
the W.H.O. Third International Standard. The addition of LH (300 mIU/ml),
FSH (1,000 mIU/ml), and TSH (1,000 mIU/ml) to negative (0 mIU/ml