QuickVue+ One-Step hCG Combo Bedienungsanleitung

clIa complexity: Waived-Urine / moderate - serum
Intended Use
The QuickVue One-Step hCG Urine test is a one-step immunoassay
intended for the qualitative detection of human Chorionic
Gonadotropin (hCG) in urine for the early detection of pregnancy.
The test is intended for use by healthcare professionals.
sUmmary and explanatIon
Human chorionic gonadotropin is a hormone normally produced
by the placenta. Since hCG is present in the serum and urine
of pregnant women, it is an excellent marker for confirming
pregnancy.
The QuickVue+ One-Step hCG Combo test is a lateral-flow test
using a monoclonal antibody specific to the beta subunit of
hCG to accurately detect hCG as early as 2 or 3 days before the
expected menses.
prIncIple of the test
To perform the test, a serum or urine sample is collected and
added to the Reaction Unit. If the sample contains hCG, a pink
vertical line forms in the Read Result Window. This pink vertical
line, together with the pre-printed blue horizontal line, form a
plus sign (+) to indicate a positive result. If hCG is not present in
the sample, the Read Result Window shows only the pre-printed
blue horizontal line, forming a minus sign (–) to indicate a
negative result.
As the sample continues to move through the test, a bar in
the Control Window becomes blue. Blue color in the Control
Window indicates that the test is functionally active and is also
evidence that the test has been performed correctly.
reagents and materIals sUpplIed
Each QuickVue+ One-Step hCG Combo test kit contains enough
materials for 30 tests (Catalog No. 00178) or 90 tests
(Catalog No. 00179).
 Reaction Unit (30 or 90)
Contains a murine monoclonal antibody and a caprine
polyclonal antibody to hCG.
 Disposable Dropper (30 or 90)
 Package Insert (1)
 Procedure Card (1)
materIals reqUIred bUt not provIded
 Timer or watch that measures minutes and seconds.
 Specimen collection containers.
WarnIngs and precaUtIons
 For in vitro diagnostic use.
 Do not use kit contents after the expiration date printed on the
outside of the kit.
 Use appropriate precautions in the collection, storage, handling
and disposal of patient samples and used kit contents.
 Use of Nitrile or Latex gloves is recommended when handling
patient samples.
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 Dispose of containers and unused contents in accordance with
Federal, State, and Local requirements.
 The Reaction Unit must remain sealed in the foil pouch just
prior to use.
 To obtain accurate results, you must follow the Package Insert
instructions.
KIt storage and stabIlIty
Store kit at room temperature 59–86°F (15–30°C), out of direct
sunlight. Do not freeze.
specImen collectIon and storage
Urine
Collect urine specimens in a clean container. Urine collected
anytime during the day can be used. For optimal results, it is best
to test the first urine voided in the morning because it contains
the greatest concentration of hCG. Samples can be stored for
8 hours at room temperature (59–86°F; 15–30°C) or up to 72 hours
refrigerated (36–46°F; 2–8°C). DO NOT freeze the urine sample.
Serum
No special patient preparation is necessary. A whole blood
specimen should be obtained by standard medical procedures.
After clotting has occurred, the separated serum should be used
for testing.
Serum specimens may be stored refrigerated (2–8°C) for up
to 48 hours prior to assay. If testing will be delayed for more than
48 hours, the sample may be frozen once at -20°C or below. If
frozen, mix after thawing. Do not re-freeze. Do not chemically
modify the serum in any way.
qUalIty control
External Quality Control
Positive and negative controls can be run with each shipment
of a new kit lot number and as otherwise required by your
laboratory's quality assurance plan. The Serum hCG Control Set
(Catalog No. 00281) or the hCG Control Set (Catalog No. 00272)
can be used for this purpose. The use of other hCG controls may
be incompatible with the assay.
1. external positive control:
Process the control as you would a patient sample. A positive
signal is indicated by a pink and blue plus sign (+) in the Read
Result Window along with a blue procedural Control Line in
the Control Window.
2. external negative control:
Process the control as you would a patient specimen. A
negative signal is indicated by a blue minus sign (–) in the
Read Result Window along with a blue procedural Control
Line in the Control Window.
Internal Control Features
The QuickVue+ One-Step hCG Combo test contains built-in control
features. The manufacturer's recommendation for daily quality
control is to document these controls for the first sample tested
each day. Quality Control log sheets are available from Technical
Support. No additional external quality control is required.
1. Internal positive procedural control:
A blue line in the Control Window is considered an internal
positive procedural control. If the test has been performed
correctly and the Reaction Unit is working properly, this
indicator will appear.
2. Internal negative procedural control:
A clear background in the Read Result Window is considered
an internal negative procedural control. If the test has been
performed correctly and the Reaction Unit is working properly,
the background will clear to give a discernable result.
If the controls do not perform as expected, do not use the test
results. Repeat the test or contact Technical Support.
procedUral notes
 DO NOT remove the Reaction Unit from the foil pouch until you
are ready to perform the test.
 Use a new disposable dropper for each sample to avoid cross-
contamination.
test procedUre
 Remove the Reaction Unit from the pouch.
 Draw serum or urine into the disposable dropper and dispense
4 drops into the Add Sample well.
 Shortly after the sample is added, a pink-to-purple color will
be seen moving across the Reaction Unit's windows. The Read
Result Window contains a pre-printed horizontal blue line on
the membrane.
 read result at 3 minutes for urine and 5 minutes for
serum.
Note: Some positive results may appear sooner.
InterpretatIon of resUlts
*Refer to the color procedure card included in the kit.
Positive Result:
The sample contains a detectable
amount of hCG when you see:
A pink and blue plus sign (+) in the
large square Read Result Window,
along with a blue line in the small
square Control Window.
NOTE: any shade of a pink vertical line in the Read Result Window
should be interpreted as a positive result.
Negative Result:
The sample does not contain detectable
amounts of hCG when you see: A blue
minus sign (–) in the large square Read Result
Window, along with a blue line in the small
square Control Window.
Invalid Result:
The result is invalid if: No blue line appears
in the small square Control Window; or
background color in the large square
Read Result Window interferes with test
interpretation. In the case of an invalid result, a
new patient specimen should be tested using
a new QuickVue+ One-Step hCG Combo test
or contact Technical Support.
If a negative result is obtained, but pregnancy is suspected, another
sample should be collected after 48–72 hours and tested.
lImItatIons
 The contents of this kit are for use in the qualitative
detection of hCG in serum or urine.
 Test results must always be evaluated with other data available
to the physician.
 A normal pregnancy cannot be distinguished from an ectopic
pregnancy based on hCG levels alone.
 Very low levels of hCG are present in serum and in urine
shortly after implantation. Positive test results from very early
pregnancy may later prove negative due to natural termination
of pregnancy. This is estimated to occur in up to 50% of
all conceptions. If a very low, faint positive serum result is
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obtained, another sample should be obtained in 48 hours and
retested. If waiting 48 hours is not medically advisable, the test
result should be confirmed with a quantitative hCG test.
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