AccuMed 160401 Instructions - Page 2

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HOW TO READ THE RESULTS
Negative (not pregnant):
Only one color band appears in the Control Zone. No apparent
band in the Test Zone. This indicates that no pregnancy has
been detected.
Positive (pregnant):
Distinct color bands appear in the Control and Test Zones. This
indicates that you are pregnant.
Invalid:
If no band is visible, or there is a visible band only in the test
region and not in the control region, the result is invalid. Repeat
with a new test kit.
NOTE: If the color in the Test Zone is weak, it is recommended
that the test be repeated in 48 hours, or if the test shows
negative but you suspect you may still be pregnant, the test
may be repeated after a few days.
WHAT TO DO WHEN YOU KNOW THE RESULT
IF THE RESULT IS POSITIVE (TWO LINES)
Consult your physician. He or she should confirm your
pregnancy after evaluating all clinical and laboratory findings. In
some rare situations the test may give a false positive result. He
or she will also give you further information and advice on your
pregnancy.
See also "Understanding test results".
IF THE RESULT IS NEGATIVE (ONE LINE)
If you have reasons to believe that you are pregnant (e.g. no
menstrual bleeding), you can repeat the test a few days later. If
the test is still negative, consult your physician.
See also "Understanding test results".
UNDERSTANDING TEST RESULTS
1. If a urine sample is too diluted (ie, low specific gravity) it may
not contain a representative level of hCG. If pregnancy is still
suspected, another urine specimen should be collected 48
hours later and tested.
2. Low concentration of hCG in a very early pregnancy can give
a negative result. In this case, another specimen should be
obtained at least 48 hours later and tested.
3. Any treatment with hCG may cause false results.
EXPECTED RESULTS
Although the hCG levels in normal early pregnant women are
variable, One Step Pregnancy Urine Test is generally capable of
detecting pregnancy as early as 1 day after the first missed
menses.
QUESTIONS & ANSWERS
1.There is a big difference between the control lines of two tests.
Is this a concern? No. Variations in the color of the control band
will not affect the test result.
2.Can test results be interpreted after more than five minutes?
No. Test results must be read in 5 minutes. A negative result
may change to a false positive within minutes after the end of
the testing period, which would not be an accurate reading. It is
always best to read the results 5 minutes after taking the test
and then discard the test to avoid confusion.
PERFORMANCE CHARACTERISTICS
Sensitivity:
One Step HCG Test has a sensitivity of 25 mIU/ml.
Interfering Substances:
The following potentially interfering substances were added to
hCG negative and positive specimens and no interference was
observed.
Acetaminophen, aspirin, ascorbic acid, atropine, caffeine,
glucose, hemoglobin, tetracycline, ampicillin , albumin, bilirubin.
MANUFACTURED FOR
AccuMed Biotech LLC
16727 Park Row Dr,
Houston, TX 77084
www.AccuMed.com
INDEX OF SYMBOLS
Consult instructions
f or use
In v itro diagnostic
medical dev ice
Store between
4 ~ 30 ºC
Keep away f rom
sunlight
Keep dry
Do not reuse
P/N: 160401
Rev. 04.2016