Chembio HIV 1/2 STAT-PAK User manual

Step 5. Read the test result after 15 minutes.
Do not read results after 20 minutes.
Refer to the INTERPRETATION OF
RESULTS Section on the other side
to determine the test results.
• Gather the material you will need
• Cover your work space with a clean, disposable,
absorbent workspace cover.
• Put on your disposable gloves.
• Let the test reach room temperature (between 18-30°C,
or 64-86°F) before opening the pouch.
Step 1. Remove the Chembio®
HIV-1/2 STAT-PAK®test device from
its pouch.
Quick Reference Instructions*
Step 2. Obtain a venous or ngertip blood sample according to your
normal laboratory practices. After pricking the nger, wipe away the
rst drop and sample from the second drop.
Touch the sample loop to the drop of blood, allowing the opening of
the loop to ll with blood.
Control Line Area
Test Line Area
Sample Well
Area for writing
Step 3. Point the sample loop down
and touch it to the sample pad in the
center of the SAMPLE (S) well of the
device. The blood sample will ow
onto the sample pad.
ADD ONLY ONE LOOP FULL OF
SAMPLE.
Step 4. Hold the Running Buffer bottle
vertically (not at an angle) ABOVE the sample
well and squeeze three (3) FREE FALLING
drops into the SAMPLE (S) well.
THREE FULL DROPS ARE NEEDED.
1
2
3 4
5
CLIA Complexity: Waived
For Fingerstick Whole Blood and Venipuncture Whole Blood Only
• These instructions are only a Reference Guide. For complete information, refer to
the Chembio®HIV 1/2 STAT-PAK®Product Insert.
• Read this Product Insert completely before using the product. Follow the
instructions carefully when performing the test as not doing so may result in
inaccurate Test Results.
• Before performing testing, all operators MUST read and become familiar with
Universal Precautions for prevention of transmission of Human Immunodeficiency
Virus, Hepatitis B Virus, and other blood borne pathogens in Health-Care Settings.
• Laboratories using this test must hold a certificate of CLIA Waiver.
• Chembio®HIV 1/2 STAT-PAK®has not been tested on newborns or children under
13.
Intended Use:
The Chembio®HIV 1/2 STAT-PAK®assay is a single-use rapid immunochromato-
graphic test for the qualitative detection of antibodies to Human Immunodeficiency
Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole
blood, serum or plasma specimens. The Chembio®HIV 1/2 STAT-PAK®assay is
intended for use as a point-of-care test to aid in the diagnosis of infection with
HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for
the statistical validation of rapid HIV test results.
FOR IN VITRO DIAGNOSTIC USE
• THIS IS A RESTRICTED DEVICE.
• SALES, DISTRIBUTION AND USE RESTRICTIONS APPLY. SEE CUSTOMER LETTER AND
PRODUCT INSERT.
Continued on reverse... * Before testing, please refer to the complete
product insert provided in the test kit.
10-6073-1 Rev. 1
Prior to testing, provide the “Subject Information Notice” to the person being tested.
HIV 1/2 STAT-PAK®Test Procedure
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Prints:
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Front

Quick Reference Instructions*
NONREACTIVE RESULT
One pink/purple line in the CONTROL (C) area,
with no line in the TEST (T) area is a
nonreactive result.
A nonreactive result at
15 minutes means that
HIV antibodies were not
detected in the sample.
Control Line
No Test Line
REACTIVE RESULT
Two pink/purple lines – one in the TEST (T) area
and one in the CONTROL (C) area –
indicate a reactive result.
NOTE: The line in TEST (T) area may not look like
the line in the CONTROL (C) area.
One may be darker than the other.
If ANY VISIBLE LINE appears in BOTH the TEST (T) area
and in the CONTROL (C) area, the result is reactive.
A CONTROL LINE MUST ALWAYS BE PRESENT IN THE CONTROL ZONE (C) FOR THE TEST TO BE VALID.
If there is no control line after 15 minutes, the test is invalid. This means there was a problem with the test. Repeat the test with a new device.
Be sure that the sample and 3 drops of Running Buffer are added correctly.
No Control Line,
with or without
a Test Line present
Misplaced
Control Line
For technical assistance,
please contact
Chembio Technical Services
at [phone]
INVALID
RESULTS
Control Line
Test Line
... continued from reverse
The following items are needed to do the test:
Chembio®HIV 1/2 STAT-PAK®kit contains:
• 20 STAT-PAK®Individually Pouched Test Devices
• 20 Copies of Subject Information Notice
• 20 Disposable 5µL Sample Loops
• 1 HIV Running Buffer (3.5mL)
• 1 Product Insert for the Chembio®HIV 1/2 STAT-PAK®assay
Materials required but not provided:
• Clock, watch, or other timing device
• Pipettor capable of delivering 5µL of sample may be used in lieu of the disposable
5µL sample loop supplied with the Kit (for other than fingerstick whole blood
specimens)
• Disposable gloves
• Sterile gauze (for fingerstick whole blood specimens)
• Antiseptic wipes
• Biohazard disposal container
• Sterile Safety Lancet (for fingerstick whole blood specimens)
• Collection devices for specimens (other than fingerstick whole blood specimens)
• Chembio®HIV Reactive/Nonreactive Controls (Catalog # 60-9549-0)
External Quality Control:
Chembio®HIV Reactive/Nonreactive Controls are available separately to use only
with the Chembio®HIV 1/2 STAT-PAK®test. The Controls are used to verify your abil-
ity to perform the test and interpret the results. Refer to the Chembio®HIV Reactive/
Nonreactive Controls Product Insert for complete instructions.
Run the Kit Controls under the following circumstances:
• Each new operator prior to performing tests on patient specimens,
• When opening a new test Kit lot,
• Whenever a new shipment of test Kits is received,
• If the temperature of the test storage area falls outside of 8 to 30°C (46 to 86°F),
• If the temperature of the testing area falls outside of 18 to 30°C (64 to 86°F),
• At periodic intervals as indicated by the user facility.
A NONREACTIVE Test Result means that HIV-1 and HIV-2
antibodies were not detected in the specimen. The Test
Result is interpreted as NEGATIVE for HIV-1 and HIV-2
antibodies. However, this does not exclude possible
infection with HIV. Follow CDC guidelines to inform the
test subject of the Test Result and its interpretation.
A REACTIVE Test Result means that HIV-1 and/or HIV-2
antibodies have been detected in the specimen. The Test
Result is interpreted as Preliminary POSITIVE for HIV-1
and/or HIV-2 antibodies. Follow CDC guidelines to inform
the test subject of the Test Result and its interpretation.
An INVALID test result means there was a problem
running the test, either related to the specimen or to the
Device. An INVALID test result cannot be interpreted.
It is recommended that the INVALID test be repeated
with a new device. Contact Chembio if you are unable to
get a valid test result upon repeat testing.
ADEQUATE LIGHTING REQUIRED
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CYAN
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MAGENTA
2 25 50 75 98 100
YELLOW
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BLACK
2/18/04
MY-3255B
Size: 16-7/8 x 8-1/2
Prints:
4 Color Process
and
Overall Aqueous
Back
HIV 1/2 STAT-PAK®Interpretation of Results