Reference Symbols Key P-5120-K Materials Maybe Required but Not Provided

1. Braunstein, G.D., Rasor, J., Adler, D., Danzer, H., and Wade,
M.E. Serum Human Chorionic Gonadotropin Levels Through- Instructions For Use (Read)
hCG • Timer

out Normal Pregnancy. Am. J. Obstet. Gynecol. 1976;

One-Step Pregnancy Test • Specimen cup
REF
Item Number
126:678. • Latex gloves
2. Krieg, A.F. Pregnancy Tests and Evaluation of Placental Store At For Professional In Vitro Use
Function in: Clinical Diagnosis and Management by Labora-
tory Methods, 16th ed., Henry, J.B. (ed.) W.B. Saunders Co.,
Expiration Date Rapid Immunoassay for the Qualitative Detection of Warning and Precautions
Contents
Human Chorionic Gonadotropin • For in vitro diagnostic use only.
Philadelphia, pp. 680, 1979. CONT
in Urine
3. Brody, S. and Carlstrom, G. Immunoasay of Human Chori- Test Device • Do not interchange materials from different product Lot’s and do
For the Early Detection of Pregnancy
DEV

onic Gonadotropin in Normal and Pathologic Pregnancy. J. not use beyond the expiration date.
Clin. Endocrinol. Metab. 1962; 22:564. IFU Instructions For Use
4. Hussa, R.O. Human Chorionic Gonadotropin, A Clinical PIP Transfer Pipette LifeSign, LLC • The Status hCG One-Step Pregnancy Test device should remain in
its sealed pouch until ready for use.
Marker: Review of its Biosynthesis. Ligand Review 1981; 3:6.
5. Swaminathan, N. and Bahl, O.P. Dissociation and Recombi- 2 Do Not Reuse
CLIA Waived
nation of the Subunits of Human Chorionic Gonadotropin. IVD For In Vitro Diagnostic Use Storage and Stability
Biochem. Biophys. Res. Commun. 1970; 40:422.
Lot Number Item No. 35135 35 Test Kit Status hCG One-Step Pregnancy Test kit should be stored at
6. Ross, G.T. Clinical Relevance of Research on the Structure of LOT
2–30°C (36–86°F) in the sealed pouch.
Human Chorionic Gonadotropin. Am. J. Obstet. Gynecol. Manufacturer
1977; 129:795. Intended Use Specimen Collection and Preparation
7. Reuter, A.M., Gaspard, U.J., Deville, J-L., Vrindts-Gevaert, Y. MF Manufactured For Status hCG One-Step Pregnancy Test is a simple immunoassay for
and Franchimont, P. Serum Concentrations of Human EC REP Authorized Representative the Qualitative Detection of Human Chorionic Gonadotropin (hCG) Urine Assay:
Chorionic Gonadotrophin and its Alpha and Beta Subunits. 1. in Urine for the Early Detection of Pregnancy.
• For optimal early detection of pregnancy, a first morning urine
CE Mark
During Normal Singleton and Twin Pregnancies. Clin. Summary and Explanation specimen is preferred since it generally contains the highest
Endocrinol. 1980; 13:305. concentration of hCG. However, randomly collected urine
Human chorionic gonadotropin (hCG) is a glycoprotein hormone
8. Morrow, C.P., et al. Clinical and Laboratory Correlates of specimens may be used.
produced by the placental trophoblastic cells shortly after the
Molar Pregnancy and Trophoblastic Disease. Am. J. Obstet fertilized ovum is implanted in the uterine wall.1-4 The primary • Collect the urine specimen in a clean glass or plastic cup.
Gynecol. 1977; 50:424-430. function of hCG is to maintain the corpus luteum during early • Urine containing excessive bacterial contamination should not be
9. Dawood, M.Y., Saxena, B.B., and Landesman, R. Human pregnancy. The appearance of hCG in both urine and serum soon used since spurious results may occur with such specimens.
Chorionic Gonadotropin and its Subunits in Hydatidiform after conception, and its rapid rise in concentration make it an
Mole and Choriocarcinoma. Am. J. Obstet. Gynecol. 1977; excellent marker for pregnancy. The hormone level may become • Bring specimens to room temperature prior to testing. Frozen
50:172–181. specimens must be completely thawed, thoroughly mixed, and
detectable in both urine and serum as early as 7 to 10 days after
10. Braunstein, G.D., Vaitukaitis, J.L., Carbone, P.P., and Ross, brought to room temperature prior to testing by allowing the
conception.1- 4 The concentration of hCG continues to rise rapidly, specimens to stand at room temperature for at least 30 minutes.
G. T. Ectopic Production of Human Chorionic Gonadotropin frequently exceeding 100 mIU/mL by the first missed menstrual
by Neoplasms. Ann. Inter. Med. 1973; 78:39-45. period and peaking in the 30,000- 100,000 mIU/mL range by 10 to
11. Steier, J.A., Bergsjo, P., and Myking, O.L. Human Chorionic 12 weeks into pregnancy. The hormone is comprised of two Specimen Storage
Gonadotropin in Maternal Plasma After Induced Abortion, non-covalently bound dissimilar subunits containing approximately • If testing will not be performed immediately, the specimens
Spontaneous Abortion, and Removed Ectopic Pregnancy. 30% carbohydrate by weight.5 The alpha subunit is structurally should be refrigerated (2–8°C) for up to 48 hours. Bring
Am. J. Obstet. Gynecol. 1984; 64:391-394. similar to other human pituitary glycoprotein hormones, whereas specimens to room temperature prior to testing.
12. Wilcox, A.J., Weinberg, C.R., O’Connor , J.F., Baird, D.D., the beta subunit confers unique biological and immunological
Schlatterer, J.P., Canfield, R.E., Armstrong, E.G., and Nisula, specificity to the molecule.6,7 • For prolonged storage, specimens may be frozen and stored
B.C. Incidence of early loss of pregnancy. N. Engl. J. Med. below –20°C. Avoid repeated freezing and thawing.
1988; 319:189-194. The Status hCG One-Step Pregnancy Test is a rapid test for detecting
13. Murray, H., Baakdah, H., Bardell, T., and Tulandi, T. Diagnosis pregnancy. The test is a solid-phase, two-site immunometric assay • If specimens are to be shipped, they should be packed in
and treatment of ectopic pregnancy. CMAJ 173: 905-912, in which a combination of monoclonal and polyclonal antibodies is compliance with Federal regulations covering the transportation
used to selectively detect hCG in urine with a high degree of sensi- of etiologic agents. For urine samples, add sodium azide to a
2005. concentration of 0.1% as a preservative and ship by the quickest
14. Cole, L.A. Immunoassay of human chorionic gonadrotropin, tivity. In the test procedure, sample is added to the sample well
means possible.
its free subunits and metabolites. Clinical Chemistry 43:12. using a dropper and sample is allowed to soak in. If hCG is present
2233-2243, 1997. in the specimen, it will react with the conjugate dye, which binds to Procedures
15. Snyder, J.A., Haymond, S., Parvin, C.A., Gronowski, A.M., the antibody on the membrane to generate a colored line. Presence
Procedural summary
and Grenache, D.G. Dynamic considerations in the measure- of two colored lines, one at the Test Position and the
other at the Control Position, indicates a positive result, while the The procedure consists of adding the specimen to the sample well
ment of human chorionic gonadotropin in aging women. in the device and watching for the appearance of colored lines on
Clinical Chemistry 51:10. 1830- 1835, 2005. absence of the line at the Test position indicates a negative result. the membrane.
Procedural notes
Reagents and Materials Provided The instructions below must be followed to achieve optimal test
Status hCG One-Step Pregnancy Test kit contains enough reagents results
and materials to perform all the tests. • Before opening the pouch, the Status hCG One-Step Pregnancy
• Status device. (Test device containing the polyclonal anti-hCG Test device must be allowed to stand at room temperature for at
coated membrane and a pad with the mouse monoclonal IgG least 30 minutes prior to testing.
(anti-hCG)-dye conjugate in a protein matrix containing 0.1%
Printed in U.S.A. Manufactured by MF Manufactured for: • Label the Status hCG device with the patient name or control
EC REP sodium azide)
P-5120-K number.
36- 9/6/12 MT Promedt Consulting GmbH • Disposable dropper
Altenhofstrasse 80
66386 St. Ingbert Princeton BioMeditech Corporation • Package insert • Handle all specimens as if capable of transmitting disease.
Germany 4242 U.S. Hwy 1, Monmouth Jct. A PBM Group Company
85 Orchard Road, • After testing, dispose of the Status hCG device, and the dropper
+49-68 94-58 10 20 New Jersey 08852, U.S.A.
1-732-274–1000 www.pbmc.com Skillman, NJ 08558
800-526-2125, 732-246-3366
www.lifesignmed.com 1
 following good laboratory practices. Consider each material that Negative • Urine samples collected after consumption of a large amount of The data demonstrate the excellent correlation between Status hCG
comes in contact with specimen to be potentially infectious. Only one pinkish-purple line, at the Control Position (C). fluids may contain a lower hCG concentration. If such a sample is One-Step Pregnancy Test and and Tandem® Icon™ II. The clinical
negative, a first morning specimen should be obtained and accuracy and sensitivity of the two tests are found comparable.
retested.
Physicians’ Office Laboratory Evaluation (Proficiency Study)
Test Procedure • Urine samples collected after consumption of a large amount of Reproducibility of Status hCG™ test was evaluated at three
fluids may contain a lower hCG concentration. If such a sample is physicians’ offices using a total of 60 blind control samples. The
(examples of negative results) negative, a first morning specimen should be obtained and
STEP 1 panels consisted of 5 negative (–), 5 low positive (25 mIU/mL hCG),
retested. 5 moderate positive (200 mIU/ mL hCG), and 5 high positive (500
For each test, open one Status hCG pouch, and NOTE: In the absence of hCG, or in the case that the hCG
concentration is below the detection limit of the test, there will be no mIU/mL hCG) samples. The results obtained at each site agreed
label the Status device with the patient ID. • In rare occasions, persistent low levels of hCG present in men and 100% with expected results.
apparent line at the Test Position (T); rather, there may be a uniform
in nonpregnant women (concentrations 3 to 100 mIU/mL) may
STEP 2 background color over the membrane area. The Control line at the
result in positive results.14,15 Sensitivity
Holding the dropper in a vertical position, add 3 drops of Control Position (C) should be clearly visible.
sample into the Sample well (S). Standard controls (calibrated to the WHO 3rd International
Invalid
User Quality Control Standard) ranging from 5 mIU/mL to 40 mIU/mL were tested in 5
STEP 3 A distinctive colored line at the Control Position (C) should always Internal Control: Each Status hCG One-Step Pregnancy Test device replicates. The results confirmed the sensitivity of 25 mIU/mL at 3–5
Read the results at 3–5 minutes. appear. The test is invalid if no Control line forms. has a built-in control. The Control line is an internal positive minute assay time.
Do not interpret the results after 5 minutes. procedural control. A distinct reddish-purple Control line should
appear at C position indicating an adequate sample volume is used, Specificity
the sample and reagent are wicking on the membrane, and the test Thirty-six urine specimens collected from menopausal women were
reagents at the Control line and the conjugate-color indicator are studied. Specimens from menopausal women are known to
reactive. In addition, the clearing background in the Result window interfere frequently with
is considered as an additional procedural control by providing a pregnancy tests due to cross-reactivity with other gonadotropin
(examples of invalid results)
distinct readable result. This may be considered an internal negative hormones such as Leutenizing hormone. These specimens were
procedural control. If background color appears in the Result assayed with Status hCG One-Step Pregnancy Test . All 36
NOTE: If there is no distinct pinkish-purple line visible at the Control window which interferes with your ability to read the test result and
Add 3 drops specimens were found negative.
Position, the test is inconclusive. The Control line should always obscure the formation of the control band, your result may be
appear. If there is a suspected procedural error, the result should be
considered inconclusive. It s recommended that in these cases the invalid. If the problem persists, contact LifeSign for technical
assistance at 1-800-526-2125. The assay is free of interference from other commonly known
test be repeated with a new test device. homologous hormones when tested against the levels specified
below (Table 2).
hCG

External Control: External controls may also be used to assure that

Limitations Table 2
S

the reagents are working properly and that the assay procedure is
T
C

followed correctly. It is recommended that a control be tested Homologous Hormones:

• Elevated hCG levels have been reported in patients with both Urine
gestational and nongestational trophoblastic diseases.8,9,10 The before using a new lot or a new shipment of kit as good laboratory
testing practice and that users follow federal, state, and local hFSH 1000 mIU/mL
hCG of trophoblastic neoplasms is similar to that found in
Interpretation of Results pregnancy, so these conditions, including choriocarcinoma and guidelines for quality control requirements. For information on how hLH 500 mIU/mL
hydatidiform mole, should be ruled out before pregnancy is to obtain controls, contact LifeSign’s Technical Services.
Positive hTSH 1000 µIU/mL
diagnosed.
Two pinkish-purple lines, one each in the Test Position (T) and in the Other Interfering Substances
Control Position (C). Each of the following indicates a positive test Expected Values
• An extremely low concentration of hCG during the early stage of At the level of claimed sensitivity, Status hCG One-Step Pregnancy
result Status hCG One-Step Pregnancy Test is capable of detecting hCG Test showed no interference when the following potentially
pregnancy can give a negative result. In this case, testing of
another specimen obtained at least 48 hours later is level of 25 mIU/mL in urine(calibrated against the WHO 3rd interfering substances, both endogenous and exogenous, were
recommended. International Standard). HCG levels in normal early pregnant women added to urine samples which had hCG levels of 0 and 25 mIU/mL
vary and hCG levels often exceed 100 mIU/mL by the first day of the (Table 3).
• The hCG level may remain detectable for several weeks after missed menstrual period.1 The test is usually capable of detecting
normal delivery, delivery by caesarean section, spontaneous hCG by the first day of the missed menstrual period. Table 3. Potentially Interfering Substances added to Urine and
(examples of positive results)
abortion, or therapeutic abortion.11 Tested with the Status hCG One Step Pregnancy Test
NOTE: A specimen containing a detectable level of hCG will
Performance Charateristics Table 3
generate a pinkish-purple line in the Test Position (T) within 3–5 • The hCG level in the case of spontaneous abortion may be very Clinical Evaluation
minutes. The time required to generate the line is dependent on the low and eventually decrease. The test is highly sensitive, and Concentration Added
specimens which test positive during the initial days after A total of 247 blind clinical urine samples were studied. These Substance Added
hCG concentration in the sample. Positive results may be detected in Urine
conception may later be negative due to natural termination of the specimens were assayed with Status hCG One-Step Pregnancy Test
in as early as one (1) minute, depending on the hCG concentration. and Tandem® Icon™ II according to the package inserts (Table 1). Drugs:
To be interpreted as positive, the pinkish-purple line at the Test pregnancy. Natural termination occurs in 22% of clinically Acetaminophen 20 mg/dL
unrecognized pregnancies and 31% of pregnancies overall.12 Thirty-six (36*) samples are from menopausal women.
position should be clearly distinguishable from the background Acetylsalicylic Acid 20 mg/dL
color of the membrane. In strong positive tests, the color intensity Subsequent testing of a new urine sample after an additional 48 Ampicillin 20 mg/dL
of the Control line (C) may be much lighter than that of the Test line hours is recommended in order to confirm that the hCG level is Table 1 (Urine Assay) Ascorbic Acid 20 mg/dL
(T). Note: The high dose hook effect has been found to occur at rising as indicated in a normal pregnancy. Atropine 20 mg/dL
Status hCG One-Step Pregnancy Test vs. Tandem®Icon™ II with Urine Caffeine 20 mg/dL
approximately 500,000 mIU/mL. For samples with extremely high Specimens
concentration of hCG, the higher the hCG concentration, the lighter • The concentration of hCG may be very low in the case of ectopic Gentisic Acid 20 mg/dL
pregnancy.13 A suspected ectopic pregnancy may be further Test Result (# of Samples) Phenothiazine 20 mg/dL
the color band at the test region may appear.
evaluated using a quantitative hCG assay. Phenylpropanolamine 20 mg/dL
Tandem®Icon™ II Status hCG Salicylic Acid 20 mg/dL
a. Two strong pinkish-purple lines, one each at the Test (T) and Tetracycline 20 mg/dL
• Very high levels of hCG may exist in certain pregnancies and Positive 78 78
Control (C) Positions pathological conditions (e.g., choriocarcinoma and hydatidiform Urinary Analytes:
Negative 133 133 Bilirubin 2 mg/dL
b. One strong pinkish-purple line at the Test Position (T) and one mole). This may weaken the intensity of test line
Menopausal Not Determined 36 (Negative) Glucose 2000 mg/dL
light pinkish-purple line at the Control Position (C). Hemoglobin 25 mg/dL
• The physician should evaluate data obtained with this kit in light
c. One light pinkish-purple line at the Test Position (T) and one of other clinical information. Overall Accuracy: 100% Ketones 100 mg/dL
pinkish-purple colored line at the Control Position (C). Albumin 2000 mg/dL
Relative Sensitivity: 100% -
• Samples which contain excessive bacterial contamination or Homologous Hormones:
Relative Specificity: 100% hFSH 1000 mIU/mL
which have been subjected to repeated freezing and thawing
should not be used because such specimens can give spurious hLH 500 mIU/mL
hTSH 1000 µIU/mL
results.

2 3
 following good laboratory practices. Consider each material that Negative • Urine samples collected after consumption of a large amount of The data demonstrate the excellent correlation between Status hCG
comes in contact with specimen to be potentially infectious. Only one pinkish-purple line, at the Control Position (C). fluids may contain a lower hCG concentration. If such a sample is One-Step Pregnancy Test and and Tandem® Icon™ II. The clinical
negative, a first morning specimen should be obtained and accuracy and sensitivity of the two tests are found comparable.
retested.
Physicians’ Office Laboratory Evaluation (Proficiency Study)
Test Procedure • Urine samples collected after consumption of a large amount of Reproducibility of Status hCG™ test was evaluated at three
fluids may contain a lower hCG concentration. If such a sample is physicians’ offices using a total of 60 blind control samples. The
(examples of negative results) negative, a first morning specimen should be obtained and
STEP 1 panels consisted of 5 negative (–), 5 low positive (25 mIU/mL hCG),
retested. 5 moderate positive (200 mIU/ mL hCG), and 5 high positive (500
For each test, open one Status hCG pouch, and NOTE: In the absence of hCG, or in the case that the hCG
concentration is below the detection limit of the test, there will be no mIU/mL hCG) samples. The results obtained at each site agreed
label the Status device with the patient ID. • In rare occasions, persistent low levels of hCG present in men and 100% with expected results.
apparent line at the Test Position (T); rather, there may be a uniform
in nonpregnant women (concentrations 3 to 100 mIU/mL) may
STEP 2 background color over the membrane area. The Control line at the
result in positive results.14,15 Sensitivity
Holding the dropper in a vertical position, add 3 drops of Control Position (C) should be clearly visible.
sample into the Sample well (S). Standard controls (calibrated to the WHO 3rd International
Invalid
User Quality Control Standard) ranging from 5 mIU/mL to 40 mIU/mL were tested in 5
STEP 3 A distinctive colored line at the Control Position (C) should always Internal Control: Each Status hCG One-Step Pregnancy Test device replicates. The results confirmed the sensitivity of 25 mIU/mL at 3–5
Read the results at 3–5 minutes. appear. The test is invalid if no Control line forms. has a built-in control. The Control line is an internal positive minute assay time.
Do not interpret the results after 5 minutes. procedural control. A distinct reddish-purple Control line should
appear at C position indicating an adequate sample volume is used, Specificity
the sample and reagent are wicking on the membrane, and the test Thirty-six urine specimens collected from menopausal women were
reagents at the Control line and the conjugate-color indicator are studied. Specimens from menopausal women are known to
reactive. In addition, the clearing background in the Result window interfere frequently with
is considered as an additional procedural control by providing a pregnancy tests due to cross-reactivity with other gonadotropin
(examples of invalid results)
distinct readable result. This may be considered an internal negative hormones such as Leutenizing hormone. These specimens were
procedural control. If background color appears in the Result assayed with Status hCG One-Step Pregnancy Test . All 36
NOTE: If there is no distinct pinkish-purple line visible at the Control window which interferes with your ability to read the test result and
Add 3 drops specimens were found negative.
Position, the test is inconclusive. The Control line should always obscure the formation of the control band, your result may be
appear. If there is a suspected procedural error, the result should be
considered inconclusive. It s recommended that in these cases the invalid. If the problem persists, contact LifeSign for technical
assistance at 1-800-526-2125. The assay is free of interference from other commonly known
test be repeated with a new test device. homologous hormones when tested against the levels specified
below (Table 2).
hCG

External Control: External controls may also be used to assure that

Limitations Table 2
S

the reagents are working properly and that the assay procedure is
T
C

followed correctly. It is recommended that a control be tested Homologous Hormones:

• Elevated hCG levels have been reported in patients with both Urine
gestational and nongestational trophoblastic diseases.8,9,10 The before using a new lot or a new shipment of kit as good laboratory
testing practice and that users follow federal, state, and local hFSH 1000 mIU/mL
hCG of trophoblastic neoplasms is similar to that found in
Interpretation of Results pregnancy, so these conditions, including choriocarcinoma and guidelines for quality control requirements. For information on how hLH 500 mIU/mL
hydatidiform mole, should be ruled out before pregnancy is to obtain controls, contact LifeSign’s Technical Services.
Positive hTSH 1000 µIU/mL
diagnosed.
Two pinkish-purple lines, one each in the Test Position (T) and in the Other Interfering Substances
Control Position (C). Each of the following indicates a positive test Expected Values
• An extremely low concentration of hCG during the early stage of At the level of claimed sensitivity, Status hCG One-Step Pregnancy
result Status hCG One-Step Pregnancy Test is capable of detecting hCG Test showed no interference when the following potentially
pregnancy can give a negative result. In this case, testing of
another specimen obtained at least 48 hours later is level of 25 mIU/mL in urine(calibrated against the WHO 3rd interfering substances, both endogenous and exogenous, were
recommended. International Standard). HCG levels in normal early pregnant women added to urine samples which had hCG levels of 0 and 25 mIU/mL
vary and hCG levels often exceed 100 mIU/mL by the first day of the (Table 3).
• The hCG level may remain detectable for several weeks after missed menstrual period.1 The test is usually capable of detecting
normal delivery, delivery by caesarean section, spontaneous hCG by the first day of the missed menstrual period. Table 3. Potentially Interfering Substances added to Urine and
(examples of positive results)
abortion, or therapeutic abortion.11 Tested with the Status hCG One Step Pregnancy Test
NOTE: A specimen containing a detectable level of hCG will
Performance Charateristics Table 3
generate a pinkish-purple line in the Test Position (T) within 3–5 • The hCG level in the case of spontaneous abortion may be very Clinical Evaluation
minutes. The time required to generate the line is dependent on the low and eventually decrease. The test is highly sensitive, and Concentration Added
specimens which test positive during the initial days after A total of 247 blind clinical urine samples were studied. These Substance Added
hCG concentration in the sample. Positive results may be detected in Urine
conception may later be negative due to natural termination of the specimens were assayed with Status hCG One-Step Pregnancy Test
in as early as one (1) minute, depending on the hCG concentration. and Tandem® Icon™ II according to the package inserts (Table 1). Drugs:
To be interpreted as positive, the pinkish-purple line at the Test pregnancy. Natural termination occurs in 22% of clinically Acetaminophen 20 mg/dL
unrecognized pregnancies and 31% of pregnancies overall.12 Thirty-six (36*) samples are from menopausal women.
position should be clearly distinguishable from the background Acetylsalicylic Acid 20 mg/dL
color of the membrane. In strong positive tests, the color intensity Subsequent testing of a new urine sample after an additional 48 Ampicillin 20 mg/dL
of the Control line (C) may be much lighter than that of the Test line hours is recommended in order to confirm that the hCG level is Table 1 (Urine Assay) Ascorbic Acid 20 mg/dL
(T). Note: The high dose hook effect has been found to occur at rising as indicated in a normal pregnancy. Atropine 20 mg/dL
Status hCG One-Step Pregnancy Test vs. Tandem®Icon™ II with Urine Caffeine 20 mg/dL
approximately 500,000 mIU/mL. For samples with extremely high Specimens
concentration of hCG, the higher the hCG concentration, the lighter • The concentration of hCG may be very low in the case of ectopic Gentisic Acid 20 mg/dL
pregnancy.13 A suspected ectopic pregnancy may be further Test Result (# of Samples) Phenothiazine 20 mg/dL
the color band at the test region may appear.
evaluated using a quantitative hCG assay. Phenylpropanolamine 20 mg/dL
Tandem®Icon™ II Status hCG Salicylic Acid 20 mg/dL
a. Two strong pinkish-purple lines, one each at the Test (T) and Tetracycline 20 mg/dL
• Very high levels of hCG may exist in certain pregnancies and Positive 78 78
Control (C) Positions pathological conditions (e.g., choriocarcinoma and hydatidiform Urinary Analytes:
Negative 133 133 Bilirubin 2 mg/dL
b. One strong pinkish-purple line at the Test Position (T) and one mole). This may weaken the intensity of test line
Menopausal Not Determined 36 (Negative) Glucose 2000 mg/dL
light pinkish-purple line at the Control Position (C). Hemoglobin 25 mg/dL
• The physician should evaluate data obtained with this kit in light
c. One light pinkish-purple line at the Test Position (T) and one of other clinical information. Overall Accuracy: 100% Ketones 100 mg/dL
pinkish-purple colored line at the Control Position (C). Albumin 2000 mg/dL
Relative Sensitivity: 100% -
• Samples which contain excessive bacterial contamination or Homologous Hormones:
Relative Specificity: 100% hFSH 1000 mIU/mL
which have been subjected to repeated freezing and thawing
should not be used because such specimens can give spurious hLH 500 mIU/mL
hTSH 1000 µIU/mL
results.

2 3
 Reference Symbols Key P-5120-K Materials Maybe Required but Not Provided
1. Braunstein, G.D., Rasor, J., Adler, D., Danzer, H., and Wade,
M.E. Serum Human Chorionic Gonadotropin Levels Through- Instructions For Use (Read)
hCG • Timer

out Normal Pregnancy. Am. J. Obstet. Gynecol. 1976;

One-Step Pregnancy Test • Specimen cup
REF
Item Number
126:678. • Latex gloves
2. Krieg, A.F. Pregnancy Tests and Evaluation of Placental Store At For Professional In Vitro Use
Function in: Clinical Diagnosis and Management by Labora-
tory Methods, 16th ed., Henry, J.B. (ed.) W.B. Saunders Co.,
Expiration Date Rapid Immunoassay for the Qualitative Detection of Warning and Precautions
Contents
Human Chorionic Gonadotropin • For in vitro diagnostic use only.
Philadelphia, pp. 680, 1979. CONT
in Urine
3. Brody, S. and Carlstrom, G. Immunoasay of Human Chori- Test Device • Do not interchange materials from different product Lot’s and do
For the Early Detection of Pregnancy
DEV

onic Gonadotropin in Normal and Pathologic Pregnancy. J. not use beyond the expiration date.
Clin. Endocrinol. Metab. 1962; 22:564. IFU Instructions For Use
4. Hussa, R.O. Human Chorionic Gonadotropin, A Clinical PIP Transfer Pipette LifeSign, LLC • The Status hCG One-Step Pregnancy Test device should remain in
its sealed pouch until ready for use.
Marker: Review of its Biosynthesis. Ligand Review 1981; 3:6.
5. Swaminathan, N. and Bahl, O.P. Dissociation and Recombi- 2 Do Not Reuse
CLIA Waived
nation of the Subunits of Human Chorionic Gonadotropin. IVD For In Vitro Diagnostic Use Storage and Stability
Biochem. Biophys. Res. Commun. 1970; 40:422.
Lot Number Item No. 35135 35 Test Kit Status hCG One-Step Pregnancy Test kit should be stored at
6. Ross, G.T. Clinical Relevance of Research on the Structure of LOT
2–30°C (36–86°F) in the sealed pouch.
Human Chorionic Gonadotropin. Am. J. Obstet. Gynecol. Manufacturer
1977; 129:795. Intended Use Specimen Collection and Preparation
7. Reuter, A.M., Gaspard, U.J., Deville, J-L., Vrindts-Gevaert, Y. MF Manufactured For Status hCG One-Step Pregnancy Test is a simple immunoassay for
and Franchimont, P. Serum Concentrations of Human EC REP Authorized Representative the Qualitative Detection of Human Chorionic Gonadotropin (hCG) Urine Assay:
Chorionic Gonadotrophin and its Alpha and Beta Subunits. 1. in Urine for the Early Detection of Pregnancy.
• For optimal early detection of pregnancy, a first morning urine
CE Mark
During Normal Singleton and Twin Pregnancies. Clin. Summary and Explanation specimen is preferred since it generally contains the highest
Endocrinol. 1980; 13:305. concentration of hCG. However, randomly collected urine
Human chorionic gonadotropin (hCG) is a glycoprotein hormone
8. Morrow, C.P., et al. Clinical and Laboratory Correlates of specimens may be used.
produced by the placental trophoblastic cells shortly after the
Molar Pregnancy and Trophoblastic Disease. Am. J. Obstet fertilized ovum is implanted in the uterine wall.1-4 The primary • Collect the urine specimen in a clean glass or plastic cup.
Gynecol. 1977; 50:424-430. function of hCG is to maintain the corpus luteum during early • Urine containing excessive bacterial contamination should not be
9. Dawood, M.Y., Saxena, B.B., and Landesman, R. Human pregnancy. The appearance of hCG in both urine and serum soon used since spurious results may occur with such specimens.
Chorionic Gonadotropin and its Subunits in Hydatidiform after conception, and its rapid rise in concentration make it an
Mole and Choriocarcinoma. Am. J. Obstet. Gynecol. 1977; excellent marker for pregnancy. The hormone level may become • Bring specimens to room temperature prior to testing. Frozen
50:172–181. specimens must be completely thawed, thoroughly mixed, and
detectable in both urine and serum as early as 7 to 10 days after
10. Braunstein, G.D., Vaitukaitis, J.L., Carbone, P.P., and Ross, brought to room temperature prior to testing by allowing the
conception.1- 4 The concentration of hCG continues to rise rapidly, specimens to stand at room temperature for at least 30 minutes.
G. T. Ectopic Production of Human Chorionic Gonadotropin frequently exceeding 100 mIU/mL by the first missed menstrual
by Neoplasms. Ann. Inter. Med. 1973; 78:39-45. period and peaking in the 30,000- 100,000 mIU/mL range by 10 to
11. Steier, J.A., Bergsjo, P., and Myking, O.L. Human Chorionic 12 weeks into pregnancy. The hormone is comprised of two Specimen Storage
Gonadotropin in Maternal Plasma After Induced Abortion, non-covalently bound dissimilar subunits containing approximately • If testing will not be performed immediately, the specimens
Spontaneous Abortion, and Removed Ectopic Pregnancy. 30% carbohydrate by weight.5 The alpha subunit is structurally should be refrigerated (2–8°C) for up to 48 hours. Bring
Am. J. Obstet. Gynecol. 1984; 64:391-394. similar to other human pituitary glycoprotein hormones, whereas specimens to room temperature prior to testing.
12. Wilcox, A.J., Weinberg, C.R., O’Connor , J.F., Baird, D.D., the beta subunit confers unique biological and immunological
Schlatterer, J.P., Canfield, R.E., Armstrong, E.G., and Nisula, specificity to the molecule.6,7 • For prolonged storage, specimens may be frozen and stored
B.C. Incidence of early loss of pregnancy. N. Engl. J. Med. below –20°C. Avoid repeated freezing and thawing.
1988; 319:189-194. The Status hCG One-Step Pregnancy Test is a rapid test for detecting
13. Murray, H., Baakdah, H., Bardell, T., and Tulandi, T. Diagnosis pregnancy. The test is a solid-phase, two-site immunometric assay • If specimens are to be shipped, they should be packed in
and treatment of ectopic pregnancy. CMAJ 173: 905-912, in which a combination of monoclonal and polyclonal antibodies is compliance with Federal regulations covering the transportation
used to selectively detect hCG in urine with a high degree of sensi- of etiologic agents. For urine samples, add sodium azide to a
2005. concentration of 0.1% as a preservative and ship by the quickest
14. Cole, L.A. Immunoassay of human chorionic gonadrotropin, tivity. In the test procedure, sample is added to the sample well
means possible.
its free subunits and metabolites. Clinical Chemistry 43:12. using a dropper and sample is allowed to soak in. If hCG is present
2233-2243, 1997. in the specimen, it will react with the conjugate dye, which binds to Procedures
15. Snyder, J.A., Haymond, S., Parvin, C.A., Gronowski, A.M., the antibody on the membrane to generate a colored line. Presence
Procedural summary
and Grenache, D.G. Dynamic considerations in the measure- of two colored lines, one at the Test Position and the
other at the Control Position, indicates a positive result, while the The procedure consists of adding the specimen to the sample well
ment of human chorionic gonadotropin in aging women. in the device and watching for the appearance of colored lines on
Clinical Chemistry 51:10. 1830- 1835, 2005. absence of the line at the Test position indicates a negative result. the membrane.
Procedural notes
Reagents and Materials Provided The instructions below must be followed to achieve optimal test
Status hCG One-Step Pregnancy Test kit contains enough reagents results
and materials to perform all the tests. • Before opening the pouch, the Status hCG One-Step Pregnancy
• Status device. (Test device containing the polyclonal anti-hCG Test device must be allowed to stand at room temperature for at
coated membrane and a pad with the mouse monoclonal IgG least 30 minutes prior to testing.
(anti-hCG)-dye conjugate in a protein matrix containing 0.1%
Printed in U.S.A. Manufactured by MF Manufactured for: • Label the Status hCG device with the patient name or control
EC REP sodium azide)
P-5120-K number.
36- 9/6/12 MT Promedt Consulting GmbH • Disposable dropper
Altenhofstrasse 80
66386 St. Ingbert Princeton BioMeditech Corporation • Package insert • Handle all specimens as if capable of transmitting disease.
Germany 4242 U.S. Hwy 1, Monmouth Jct. A PBM Group Company
85 Orchard Road, • After testing, dispose of the Status hCG device, and the dropper
+49-68 94-58 10 20 New Jersey 08852, U.S.A.
1-732-274–1000 www.pbmc.com Skillman, NJ 08558
800-526-2125, 732-246-3366
www.lifesignmed.com 1