RPS AdenoPlus User manual

TEST
CONTENTS
R
QUICK REFERENCE GUIDE
To place an order, call +1.941.556.1850,
email [e-mail], or visit www.RPSdetectors.com
IMPORTANT
See package insert, including QC secon, for complete instrucons for use, precauons, and study results. For quesons
and technical support, call +1.941.556.1850.
INTENDED USE
AdenoPlus is a rapid immunoassay test for the visual, qualitave in vitro detecon of Adenoviral angens (hexon protein)
directly from human eye uid. The test is intended for professional use as an aid in the rapid dierenal diagnosis of acute
conjuncvis. Negave results do not preclude Adenovirus infecon nor are they intended to rule out other microbial-
caused infecons of the conjuncva, and should not be used as the sole basis for treatment or other management
decisions.
EXTERNAL QUALITY CONTROL
Posive and negave controls are available directly from RPS. Please refer to the AdenoPlus external controls package
insert for more informaon.
Sample Collector
AdenoPlus®
Buer VialTest Cassee
Note: An unused AdenoPlus device has two faint orange lines in the
result window.
1. Gently dab and drag the sampling eece in mulple locaons along the
inside of the paent’s lower eyelid (palpebral conjuncva) 6-8 mes,
and then allow it to rest against the conjuncva for an addional 5
seconds. Upon saturaon with tear uid, the eece will glisten.
2. Assemble the test by gently placing the sampling eece of the sample
collector into the sample transfer window of the test cassee body.
3. Press rmly where indicated unl the test feels secure. A double-click
means the test is properly assembled.
4. Open the buer vial and immerse the absorbent p for a minimum of
20 seconds.
5. Remove the absorbent p from the buer vial, replace the protecve cap,
and place the test horizontally on a at surface for 10 minutes.
TEST PROCEDURE

QUICK REFERENCE GUIDE
To place an order, call +1.941.556.1850,
email [e-mail], or visit www.RPSdetectors.com
Rapid Pathogen Screening, Inc.
7227 Delainey Court • Sarasota, FL 34240 USA • +1.941.556.1850 • RPSdetectors.com
©2013 Rapid Pathogen Screening, Inc. All Rights Reserved. FORM-MKT-014.2 Aug 2013
1. For in vitro diagnosc use only.
2. Keep the test cassee and sample collector in their foil pouches unl just before use.
3. The Dacron material used in the sampling eece may cause allergic reacons for some people.
4. Do not use AdenoPlus past the expiraon date.
5. All specimens should be considered potenally hazardous and handled in the same manner
as an infecous agent. Proper handling and disposal methods should be established according to
local, state, and federal regulaons.
6. Wear disposable gloves while handling samples and wash hands aer the test is complete.
7. Both AdenoPlus and the buer vial are single use items. Do not reuse with mulple specimens.
8. AdenoPlus requires a visual readout. Do not interpret the test result if you have color-impaired vision.
9. Result interpretaon requires a brightly lit environment.
10. Do not use the same AdenoPlus test kit on more than one paent.
WARNINGS AND
PRECAUTIONS
Once the background within the result window is white and 10 minutes have elapsed,
the test may be accurately read.
Note: Do not interpret the test results before compleng 10 minutes of development me.
A purple uid wave may be observed moving across the result window while the test is
running.
The results of the test are indicated through two lines which appear in the result window:
the control line and the result line. The control line appears as a BLUE line in the control
zone. It indicates the correct applicaon and performance of the test, and must appear for
the test to be valid.
POSITIVE RESULT
The presence of both a BLUE line in the control zone and a RED line in the result zone
indicates a posive result. Even if the RED line is faint in color, incomplete over the width
of the test strip, or uneven in color, it must be interpreted as posive. A posive result
indicates the presence of Adenovirus angens.
NEGATIVE RESULT
The presence of only a BLUE line in the control zone indicates a negave result. A negave
result is indicave of an absence of Adenovirus angens.
INVALID RESULT
If a BLUE line does not appear, the test may be invalid. Reimmerse the absorbent
p into the buer vial for an addional 10 seconds. If a BLUE line sll does not
appear, the test must be discarded and the subject retested by resampling the eye using a
new AdenoPlus test kit.
THE TEST RESULTS
POSITIVE
NEGATIVE
INVALID