hCG-1000 MIDSTREAM TEST
Check4®-hCG(hl) Test-Instructions for professional use
Product Code 3060
The Check4®hCG(hl)-1000 Midstream test is a rapid qualitative
assay for the detection of human chorionic gonadotropin in
urine.
The method employs a unique combination of monoclonal-dye
conjugate and polyclonal-solid phase antibodies to selectively
identify hCG in the test samples. The sensitivity of the test has
been adjusted to1,000 mIU/mL. As the test sample flows
through the absorbent portion of the device, the labelled
antibody-dye conjugate binds to the hCG forming an antibodyantigen complex. This complex binds to the anti-hCG antibody
in the positive reaction zone and produces a pink band when the
hCG concentration is greater than 1,000 mIU/mL. In the
absence of hCG, there is no line in the positive reaction zone.
The reaction mixture continues flowing through the absorbent
portion of the dipstick past the positive reaction zone and
control zone. Unbound conjugate binds to the reagents in the
control zone, producing a pink band, demonstrating that the
reagents are functioning correctly. The device in a different
plastic casing has been used in telephone follow up and selftesting after early medical abortion11.
II. KIT COMPONENTS
Each box contains everything needed to perform 20 tests :
- hCG-1000 Midstream tests :
20
- Home use instruction leaflet :
20
-Professional use instruction leaflet
1
III. STORAGE AND STABILITY
1- All hCG-1000 Midstream test kit components should be
stored at room temperature (+4°C to +30°C) in the foil pouch.
2- Do not freeze the test kit.
3- hCG-1000 Midstream test is stable until the expiry date stated
on the package label.
IV. PRECAUTIONS
1- This test is designed for in vitro diagnostic use only.
2- Please carefully read this instruction leaflet before using the
test.
3- Do not use beyond the expiry date which appears on the foil
package label.
4- Do not use a test from a damaged foil pouch.
V. ASSAY PROCEDURE
1- Remove the hCG-1000 Midstream test from its protective foil
pouch. Discard the desiccant. The midstream test must be
handled by the end opposite to its absorbent pad shown as the
left hand side on the diagram opposite.
2- Remove the right hand side cap to expose the absorbent pad.
Hold the midstream absorbent pad under the urine flow for 5 to
10 seconds (or dip for 5 to 10 seconds directly into urine which
can be collected in a clean and dry container).
3- Put the midstream test on a flat surface and read results at 10
minutes. Some positives may appear before 10 minutes which
means the test is complete.
VI. READING TEST RESULTS
1. Negative : One coloured band (control band) at 10 minutes.
Right = Absorbent pad
Test area
Control area
Left side
2. Positive : In addition to the control band, a clearly
distinguishable band also appears in the test region indicating
presence of hCG in the sample.
3. Inconclusive : In the absence of control band, the test is
inconclusive. In this case, it is recommended that the test be
repeated or a fresh specimen be obtained and tested 48 hours
later.
VII. PERFORMANCE CHARACTERISTICS
a) Sensitivity
The sensitivity of the hCG-1000 Midstream test is
1,000mIU/mL, using WHO 4th International Standard
N° 75/589.
b) Specificity
31 negative urine samples collected from non pregnant women
have been assayed with hCG-1000 Midstream test and a
commercially available rapid test according to the given
procedures. Results are summarized in the following table.
hCG-1000
Midstream
Test
I. PRINCIPLE
Rapid Test
+
-
Total
+
-
0
0
0
31
0
31
According to the above results specificity is : 31 x 100 = 100 %
31
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c) Hook effect
Specimens containing high levels of hCG (1,000,000 mIU/mL)
consistently showed positive results when tested with the hCG1000 Midstream test.
d) Cross reactivity
The following concentration of homologous hormones are found
to have no interference with hCG-1000 Midstream test :
hTSH
hLH
hFSH
1,000 µIU/mL
500 mIU/mL
1,000 mIU/mL
WHO 68/38
WHO 2nd IS 80/552
WHO 1st IS 83/575
Menopausal urines :
A study was performed using 50 urine specimens from non
pregnant or post-menopausal women. Specimens from postmenopausal women were chosen because urine from these
individuals frequently interferes with pregnancy tests, due to
cross reactivity with other gonadotropin hormones.
All 50 urine specimens tested over 5 days were negative when
tested with hCG-1000 Midstream test.
e) Interferences
Potentially interfering substances were added to urine which had
hCG levels of 0 and 25 mIU/mL. The level of interfering
substances was determined to be in excess of levels that would
be excreted after 8 hours by the human kidney.
In each case, no interference with the expected results of
hCG-1000 Midstream test was observed.
Acetaminophen
Albumin
Ampicillin
Ascorbic acid
Atropin
Bilirubin
Caffeine
Gentisic acid
Glucose
Haemoglobin
Tetracycline
20 mg/dL
1.4 g/dL
20 mg/mL
20 mg/dL
20 mg/dL
30 mg/mL
20 mg/mL
20 mg/mL
2 g/dL
30 mg/mL
40 mg/mL
VIII. LIMITATIONS
1- In addition to pregnancy, hCG has been found in patients
with both gestational and non-gestational trophoblastic disease.
Since the hCG of trophoblastic neoplasms is similar to that
found in pregnancy, these conditions, which include
choriocarcinoma and hydatidiform mole, should be ruled out
before a diagnosis of pregnancy is reached.
2- A normal pregnancy cannot be distinguished from an ectopic
pregnancy based on hCG levels alone. Also, spontaneous
miscarriage may cause confusion in interpreting test results.
3- hCG levels may remain detectable for several weeks after
normal delivery, delivery by caesarean section, spontaneous
abortion or therapeutic abortion.
4- As it is true with any diagnostic procedure, the physician
should evaluate data obtained by the use of this kit in light of
other clinical information.
5- The presence of hydroxyethyl-cellulose in the composition of
catheter lubricant may give false positive results with hCG-1000
Midstream test at a concentration equal or higher than 0.1%.
IX. BIBLIOGRAPHY
1- Braunstein, G.D., Rasor, J., Adler, D., Danzer, H., and
Wade, M.E., 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., and Ross,
G.T., Endocrinology, 94, 1601-1606 (1974).
4- Kohler, G. and Milstein, C., Nature, 256, 495-497 (1975).
5- Thompson, R.J., Jackson, A.P., and Langlois, N., Clin.
Chem., 32, 476-481 (1986).
6- Engvall, E., Methods in Enzymology, 70, 419-439 (1980).
7- Rasor, J.L., and Braunstein, G.D., Obstet. Gynecol., 50,
553-558 (1977).
8- Lenton, E.A., Neal, L.M., and Sulaiman, R., Fertility and
Sterility, 37, 773-778 (1982).
9- Elliott, M.M., Kardana, A. Lustbader, J.W. and Cole L.A.
Endocrine, 7, 15-32 (1997).
10- Cola, L.A. Clin. Chem., 43, 2233-2243 (1997).
11-Cameron, S.T., Glasier A., Dewart H., Johnstone A. and
Burnside A. Contraception 2011.11.010
Temperature limitations
Consult operating instructions
Do not re-use
In vitro diagnostic use
Manufactured by: VEDALAB – France
Distributed by: Quadratech Diagnostics Ltd, PO Box 167,
Epsom, Surrey KT18 7PE, UK info@quadratech.co.uk
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