FUTURA SYSTEM S.r.l. PREGNANCY ONE STEP
APPARECCHI SCIENTIFICI DIAGNOSTICI QUALITATIVE DETERMINATION OF THE hCG 00060 FORMELLO – Zona Industriale ( Roma ) - Via degli Olmetti, 18IN SERUM AND URINE TEL. 06/9075726 – 06/90400314 Fax. 06/9075724 RAPID IMMUNOCHROMATOGRAPHIC METHOD E - mail: [email protected] Packaging Procedure REF. N° CR71 25 Tests 1. Remove the “reaction device” from its protective wrapper by tearing along the split REF. N° CR70 50 Tests 2. Fill the pipette with specimen (serum/urine) 3. By olding it vertically dispense 4 drops exactly (~150 µl) of serum or urine into sample well (to add the next drop only when has been absorb the previous drop) 4. Read the results after 5 to 10 minutes Principle Reading test results
The “PREGNANCY ONE STEP” is a rapid qualitative assay for the detection of human
chorionic gonadotropin in serum and urine.
The method employs an unique combination of monoclonal - dye conjugate and
polyclonal solid phase antibodies to selectively identify hCG in the test samples (high
degree of sensitivity: in less than 5 minutes, levels of hCG as low as 25 mIU/ml can be
Coloured band in the “Control zone”(C)
As the test sample flows through the absorbent device, the labelled antibody - dye
coniugate binds to the hCG forming an antibody - antigen complex.
The complex binds to the anti - hCG antibody in the reaction zone and produces a pink
Coloured band in the “Test zone” (T) e “Control zone” (C)
- rose colour band when hCG concentration is higher than 25 mIU/ml.
In the absence of hCG, there is no line in the reaction zone.
The mixture continues flowing through the absorbent device past the reactive zone
and control zone. Unbound conjugates binds to the reagents in the control zone,
There is no distinct colour visible in the Control zone
producing a pink - rose colur band, demonstrating that the reagents are functioning
In this case to repeat the test with a new card Performance Characteristics Reagents composition, Contents and Safety warnings A. ACCURACY CARDS and DISPOSABLE PLASTIC PIPETTES
The product is capable of detecting hCG levels of 25 mIU/ml according to WHO 4th International Standard N° 75/589.
Sensitivity can be increased by extending the reading time to 15 minutes. Thus 5 mIU/ml can be detected in serum
Unique combination of monoclonal - dye conjugate and polyclonal solid phase antibodies
The accuracy study was also performed by determining the qualitative recovery of known amounts of human chorionic
According to the present laws the kit does not contain substances classified as
gonadotropin added to the negative urine pool:
dangerous. Final hCG Concentration Expected Observed In the pool (mIU/ml) 0 negative negative 25positive positive 50 positive positive 100 positive positive Storage and Stability of Reagents B. SENSITIVITY AND SPECIFICITY Store the kit at Room Temperature Serum samples
A study was performed using a total of 122 positive and negative serum specimen. These specimens were assayed
The cards are stable until the stated expiration date if stored closed
with “Pregnancy one step” and “Hybritech Tandem II test” according to the given procedures. Results are summarized in the following table:
Hybritech Tandem II Pregnancy < 10 U/l 10 - 20 U/l > 20 U/l Preparation of Reagents Cards: ready to use
The results show a good correlation between the Pregnancy one step and Hybritech Tandem II Urine samples
A study was performed using 95 positive urines. These specimimens were assayed with “Pregnancy one step” and
“Latex Prognosis Roche”. Results are summarized in the following table:
Prognosis Pregnancy Specimen collection and preparation
31 samples collected from non pregnant women have been assayed with “Pregnancy one step” and a commercially available rapid test. Results are summarized in the following table:
Commercial rapid test
1. To collect the sample under the standard laboratory conditions (aseptically in such a
2. No centrifugation or filtration of serum is required
3. Patients samples are best performed if tested immediately. C. HOOK EFFECT
If the sample cannot be tested within 24 hours, store at 2 - 8° C for 48 hours or
Specimen containing high levels of hCG (1,000,000 mIU/ml) when tested consistently gave positive results.
longer freeze until the test can be performed and allow sample to reach Room
D. CROSS REACTIVITY
The following concentration of homologous hormones are found toh ave no interferences with Pregnancy one step:
hTSH 1000 µIU/ml WHO 68/38
Note: In the case of cloudiness, high viscosity or presence of particulate matter in the serum hLH 500 mIU/ml WHO 2nd IS 80/552 hFSH 1000 mIU/ml WHO 1st IS 83/575 specimen, it should be diluted with equal volume (v/v) of diluting buffer (not provided but available upon request) before testing.
A study was performed using 50 urine specimens from non pregnant or post - menopausal women. The specimen
from post - menopausal women were chosen because urine from these patients frequently interfere with pregnancy
1. For optimal detection of early pregnancy, a first morning urine specimen is preferred
tests due to cross reactivity with other gonadotropin hormones.
since it contains the highest concentration of hCG.
All 50 urine specimens tested over 5 days were negative when tested with Pregnancy one step.
However, randomly collected urine specimens may be used.
E. REPEATABILITY AND REPRODUCIBILITY Intra assay (N = 5 replicates)
2. Collect the urine specimen in a clean container without preservatives.
Within run precision was determined by using 5 replicates of five specimen containing 0, 10, 25 mIUIml, 5 kIU e 500
3. If testing is not immediate,the specimen should be refrigerated (2 - 8°C) or kept cool
The negative and positive values were correctly identified 100% of the time.
(below 25° C) for up to 24 hours. In suc h case bring the specimen to Room
Between run precision was determined by using the same five specimen with three different lots of reaction device.
Again, the negative and positive values were correct 100% of the time.
If testing is delayed more than 24 hours, the specimen should be frozen.
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 what would be excreted after 8 hours by the human kidney. In each case, no interference with the expected results of Pregnancy one step were observed Acetaminophen 20 mg/dl Bilirubin 30 mg/ml Tetracycline 40 mg/ml Safety precautions Albumin 1,4 g/dl Caffeine 20 mg/ml Ampicillin 20 mg/ml Gentisic Acid 20 mg/ml Ascorbic acid 20 mg/dl Glucose 2 g/dl
Exercise the normal precautions required for handling laboratory reagents
Atropin 20 mg/dl Hamoglobin 30 mg/ml
1. Urine from healthy men and non - pregnant women will normally show undetectable levels of hCG
1. Braunstein G. D., Rasor J., Adler D., Danzer H. and Wade M.E.: Am. J. Obstet.
Although the hCG levels in normal early pregnant women are variable, the Pregnancy one step is
usually capable of confirming pregnancy by the first day of the missed menstrual period.
2. Braunstein G. D., Vaitukaitis J. L., Carbone P. P. and Ross G.T.: Ann. Inter. Med.
2. 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,
3. Morgan F. J.,Canfield R. E.,Vaitukaitis J. L.and Ross G.T.:Endocrinology, 94,1601 -
should be ruled out before a diagnosis of pregnancy is reached.
3. A normal pregnancy can be distinguished from an ectopic pregancy based on hCG levels alone.
4. Kohler G. and Milstein C.: Nature, 256, 495 - 497 (1975)
Also, spontaneous miscarriage may cause confusion in interpreting test results.
4. A very early pregnancy containing an extremely low concentration of hCG can give a negative
5. Thompson R. J., Jackson A.P.and Langlois N.: Clin. Chem., 32, 476-481 (1986)
result. In this case, another specimen should be obtained at least 48 hours later and tested.
5 hCG levels may remain detectable for several weeks after normal delivery, delivery by caesarean
6. Engvall E.: Methods in Enzymology, 70, 419 - 439 (1980)
section, spontaneous abortion or therapeutic abortion.
6. Some serum specimens with high concentration of rheumatoid factor (RF), heterophiles or
7. Rasor J. L. and Braunstein G. D.: Obstet. Gynecol., 50, 553 - 558 (1977)
Forssman antibodies may yield non specific positive results durino testing. Such cases should be
8. Lenton E. A., Neal L.M. and Sulaiman R.:Fertility and Sterility, 37, 773 -778 (1982)
7. As it is true with any diagnostic procedure, the physician should evacuate data obtained by the use
9. Elliott M. M., Bardana A., Lustbader J. W. and Cole L. A. Endocrine 7, 15 - 32
of this kit in light of other clinical information.
8. The presence of hydroxyethyl - cellulose in the composition of catheter lubricant may give false
positive results with Pregnancy one step at a concentration equal or higher than 0.1%
Rev. 006 December 2005 EN ISO 9001:2000 CERTIFIED COMPANY
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