Pregnancy Test Operating Instruction

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0123
Pregnancy Test Operating Instruction
Doc. No.: IFU-HCG Strip, A/1-20150708
CONTENTS
Each box contains: the pouch and the operating instruction.
Each pouch contains: the Pregnancy Test Strip and the Desiccant.
INTENDED USE
EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid
chromatographic immunoassay for the qualitative detection of human
Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection
of pregnancy by both professional and home users.
STORAGE AND STABILITY
The test kit can be stored at room temperature (4℃-30℃) in the sealed pouch
to the date of expiration.
The test kits should be kept away from direct sunlight, moisture and heat.
Do not freeze.
SUMMARY AND EXPLANATION
One Step HCG Urine Pregnancy Test measures the presence of the hormone
Human Chorionic Gonadotrophin (HCG) in human urine for the early detection
of pregnancy. During pregnancy, the placenta produces HCG after the embryo
attaches to the uterine lining. This test is capable of detecting pregnancy the
first day after a missed period. As pregnancy progresses, urine contains higher
the levels of HCG at concentrations of 25mIU/ml (Milli-International Units) or
greater. The concentration of HCG in non-pregnant women is normally
5.0mIU/ml. At the time of the last missed menstrual period, urine HCG levels
are about 100mIU/ml with peak levels of 100,000 to 200,000mIU/ml.
PRINCIPLE
The HCG assay is a rapid one-step test based on immunochromatographic
technology. A membrane with an absorbent pad over a strip of fiber glass paper
is impregnated with a colloidal conjugate of gold particles and monoclonal
antibodies to HCG. Other absorbent pads at the end of the assay absorb excess
sample fluid. The urine sample is introduced into a chromatographic membrane.
As it contacts the membrane, the sample dissolves the lyophilized conjugate. In
a reactive sample, the HCG antigen will attach to the antibodies in the colloidal
solution. As the conjugate moves forward on the membrane, anti-HCG
monoclonal antibodies affixed on the test zone (“T”) will bind the HCG-gold
conjugate complex, forming a pink line (“T”). Any sample will cause a pink
colored line to appear in the control zone (“C”). This line is formed by the
binding of polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone
to the sample-colloidal gold conjugate. Presence of this line indicates that the
test has been carried out correctly.
PRECAUTIONS
1. FOR IN-VITRO DIAGNOSTIC USE ONLY (IVD), NOT for internal use.
2. Read directions for use carefully before performing this test. Perform each
step exactly as described.
3. Do not use beyond the expiration date marked on the foil pouch.
4. Each one step HCG pregnancy Test can only be used once; do not re-use the
one step HCG pregnancy Test
5. Do not use the Test if the foil pouch is damaged.
6. Once the foil pouch has been opened, the Test should be used immediately.
7. Discard each one step HCG pregnancy Test after use. Treat urine samples
and used test devices as if they were potentially infectious. Avoid contact
with skin.
8. KEEP OUT OF REACH OF CHILDREN.
MATERIALS REQUIRED BUT NOT PROVIDED
timer
TEST PROCEDURE
1. SAMPLE COLLECTION AND HANDLING
To perform this test, collect a urine sample into a clean and dry container.
Urine samples collected first thing in the morning are ideal because they
generally contain higher concentration of HCG. However, urine samples
collected at any time of the day may also be used.
2.
TO CARRY OUT THE TEST
Absorbent cotton
Test line
Control line
DIRECTIONS FOR USE
· Bring the sealed pouch to room temperature.
· Remove the strip from the foil pouch.
· Immerse the strip into the urine with the
arrow end pointing toward the urine cup.
Do not cover the urine over the MAX
(maximum) line.
· Take the strip out of the cup after a
minimum of 15 seconds and lay it flatly
on a non-absorptive, clean surface.
· Read the result in 5 minutes.
· Discard the test device after a single use.
Depending on the concentration of HCG in the urine sample, positive results
may be seen within 40 seconds. Wait the full five minutes to confirm the
result. Do not read the one step HCG pregnancy Test after 5 minutes as this
may give an incorrect test result.
This is a single use test. Please safely dispose of the strip, regard this as
infectious material and dispose of the test appropriately after use.
3. HOW TO READ THE RESULT
Positive: If two pink/purple colored lines
appear on the one step HCG pregnancy
Test, one in the control area and one in the
test area, then this means HCG has been
detected in the urine and there is a strong
possibility of pregnancy. The lines seen may
be faint and one line may be lighter than
the other; however this is still a positive
result. The lines do not have to match in strength or color.
Negative: If one colored pink/purple line appears in the control area on the
one step HCG pregnancy Test and there is no line in the test area, then this
indicates a negative result. This means no HCG has been detected in the
urine. This indicates you are either not pregnant or you have tested too
early. If you are not sure repeat the test in 48 hours.
Invalid: If no lines appear anywhere on the control zone, the test is invalid
and repeat the test using another strip.
Invalid Test Results can be caused by:
· The absorbent tip not being wetted thoroughly.
· Reading the test result too early or too late. A 5 minutes reaction time
is required.
For further information, see LIMITATIONS OF THE PROCEDURE.
4. QUALITY CONTROL
Built in Quality Control Features:
The appearance of a line in the control area indicates that the one step HCG
pregnancy Test is performing properly and serves as a procedural control. It is
recommended that a positive hCG control (containing 25-250mIU/mL hCG) and
a negative hCG control (containing 0mIU/mL hCG) are evaluated to verify proper
test performance when a new shipment of tests is received.
PERFORMANCE CHARACTERISTICS
1. SENSITIVITY
One Step HCG Urine Pregnancy Test Kit will display positive results with
specimens containing HCG at levels of 25mIU/ml or greater.
2. ACCURACY
Comparison studies on the One Step HCG Urine Pregnancy Test Kit with a legally
marketed device were performed in-house and in a clinical reference laboratory.
Positive and negative results were compared and the correlation was>99%.
3. SPECIFICITY
The following compounds exhibited no interference when dissolved in urine,
which had HCG levels of 0 and 25 mIU/ml.
hLH……………………………………………………….500mIU /ml
hFSH…………………………………………………….1000mIU/ml
hTSH……………………………………………………. 1000μIU/ml
Acetaminophen
Acetoacetic Acid
Asorbic Acid
B-hydroxybutyrate
Caffeine
Ephedrine
Gentisic Acid
Phenylpropanolamine
Salicylic Acid
Phenothiazine
EDTA
Acetylsalicylic Acid
Benzoylecgonine
Cannabinol
20mg/dL
2000mg/dL
20mg/dL
2000mg/dL
20mg/dL
20mg/dL
20mg/dL
20mg/dL
20mg/dL
20mg/dL
80mg/dL
20mg/dL
10mg/dL
10mg/dL
Codeine
Ethanol
Methanol
Albumin
Glucose
Bilirubin
Atropine
Estriol-17-beta
Hemoglobin
Pregnanediol
Thiophene
Ampicillin
Tetracycline
Ketone
6ug/dL
1.0%
10%
2000mg/dL
2000mg/dL
2mg/dL
20mg/dL
1400ug/dL
500mg/dL
1500ug/dL
20mg/dL
20mg/dL
20mg/dL
20mg/dL
LIMITATION OF THE PROCEDURE
Performing the test too early can yield a false negative due to low HCG levels. In
this case, another urine specimen should be obtained at least 48 hours later and
tested.
HCG levels may remain detectable for several weeks after normal delivery,
delivery by caesarean section, or spontaneous abortion.
If urine sample is too dilute (ie: low specific gravity) it may not contain a
representative level of HCG. If pregnancy is still suspected, wait 48 hours.
Collect a urine sample first thing in the morning and retest it with another strip
test. As is true with any diagnostic procedure, the user should evaluate data
obtained by the use of this kit with consideration to other clinical information
and consult their doctor for the final diagnosis of pregnancy before making any
decision of medical relevance.
BIBLIOGRAPHY
1.Batzer, F.R. Fertility & Sterility, Vol 34, 1 1980
2.Catt, K.J. Dufan, M.L. and vaitukaitis, J.L. J.
3.Clin. Endocrinol Metab., Vol. 40,537, 1975
4.Braunstein, G.D., Rasor, J., Alder, D., Danzer H.,
5.Wade, M.E. Am. J. Obster. Gynecol., Vo. 126,678,1976
6.Lenton, E.A., Neal L.M., Sulaiman, R. Fertility and Sterility, Vol. 37,773, 1982
7.Batzer, F.R. Fertility & Sterility, Vol, 34, 1 1980
8.Dawood, M.Y., Sexeba, B.B., and Lanesman, R. Ob. Gyn. Vol. 126, 678, 1976
9.Braustein, G.D., et Al. AM. Inter. Med. Vol. 78, pp. 419-439, 1980
10.Uotila, M., Ruoslahti, E. And Engvall, H.J. Immunol. Methods, Vol. 42, 11,
1981
11.C. Galfre, S.C. Howe, C. Milstein, G.N. Butcher, and J. C. Howard, Nature 266,
550, 1977
12.M.N. Iscove and F. Melchers, J. Exp Med. 147, 923, 1978
13.PL.,Ey,et.Al.,Immunochemistry 15,429,1978
INDEX OF SYMBOLS
For in vitro
diagnostic use only
See
instruction for
use
Store between
4~30℃
Do not reuse
Batch number
Expiry date
Authorized
representative
Tests per kit
Keep dry
Keep away
from sunlight
Nantong Egens Biotechnology Co.,Ltd
Building 15,Building 12( west) , No. 1692 Xinghu Avenue, Nantong Economy &
Technology Development Zone,226010 Nantong , P.R. China.
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, D- 20537
Hamburg,Germany
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