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 fingertip blood sample according to your
normal laboratory practices. After pricking the finger, wipe away the
first drop and sample from the second drop.
Touch the sample loop to the drop of blood, allowing the opening of
the loop to fill with blood.
Control Line Area
Test Line Area
Sample Well
Ar
ea
f
or
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 flow
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
2
25
50
75
98
100
CYAN
2
25
50
75
98
100
MAGENTA
2
25
50
75
98
100
YELLOW
2
25
50
75
98
100
BLACK
2/18/04
MY-3255B
Size: 16-7/8 x 8-1/2
Prints:
4 Color Process
and
Overall Aqueous
Front
