Alere TestPack+Plus Strep A, Руководство пользователя, Страница: 4 / 58

INTENDED USE
Alere TM TestPack Plus Strep A with On Board Controls (OBC)
( Alere TM TestPack Strep A ) is a rapid immunoassay for the qualitative
detection of Group A Streptococcal (Group A Strep) antigen from throat swab
specimens as an aid to the diagnosis of Group A Strep pharyngitis or for culture
confirmation. For professional
in vitro diagnostic use only.
INTRODUCTION
Beta-haemolytic Group A Streptococcus is a major cause of upper respiratory
infections in humans. The most commonly occurring Group A Streptococcal
disease is pharyngitis. The symptoms of this, if left untreated, can become more
severe and further complications such as acute rheumatic fever, toxic shock-
like syndrome and glomerulonephritis can develop
1 . Rapid identification can
facilitate clinical management to prevent disease progression.
Alere TM TestPack Strep A employs the Lancefield grouping method of
identification, where Streptococcal groups are identified according to their cell
wall antigens, which are species specific
2,3 .
Conventional methods used to identify Group A Streptococcus involve the
isolation and subsequent identification of the organisms, which can take 24-48
hours to complete
2,4 .
Alere TM TestPack Strep A detects Group A Streptococci directly from throat
swabs so that more rapid results are achieved. The test detects bacterial
antigen from swabs, therefore it is possible to detect Group A
Streptococcus ,
which may fail to grow in culture.
TEST PRINCIPLE
The Streptococcal Group A specific antigen is extracted from the throat
swab using Reagent 1 and Reagent 2. Following this, Reagent 3 is added to
neutralise the acid formed by Reagents 1 and 2. The extract is then dropped
into the Sample Well of the reaction disc where it mobilises the Group A Strep
antibody-coated colloid, which migrates through the membrane to the End of
Assay Window.
If Group A Streptococcal antigen is present in the extract it will form a complex
with the antibody-colloid. The antibody-colloid complex migrates through the
membrane and is then captured by the Group A Strep antibody in the result
window, providing a visual indication of the presence of antigen.
A pink/red Plus Sign “+” appearing in the Result Window indicates the
presence of Group A Strep antigen. A Minus Sign “–“ indicates no antigen
was detected.
KIT CONTENTS AND STORAGE
EN
Result Window
Sample Well
2.0 M Sodium Nitrite (& Xylenol Orange) (5 mL/10 mL)
1.0 M Acetic Acid (5 mL/10 mL)
1.0 M Tris Buffer (Preservative: Sodium Azide) (5 mL/10 mL)
PRECAUTIONS
Standard guidelines for handling infectious agents should be observed
throughout all procedures.
1. It is recommended that disposable gloves be worn whilst handling
specimens and reagents.
2. Do not mix extraction reagents and reaction discs from different lots.
3. Do not mix reagent bottle caps.
4. Reagent 2 or Reagent 1 combined with Reagent 2 is acidic. Avoid contact
with eyes or mucous membranes. In the event of accidental contact, wash
thoroughly with water.
5. Reagent 3 contains sodium azide, which on contact with lead and copper
plumbing may react to form explosive metal azides. Use large volumes of
water to flush reagents on disposal.
6. Properly dispose of all contaminated waste such as swabs, reaction discs
and extraction tube.
7. Do not use reaction discs or swabs that have become wet or if the pouch
has been opened or damaged.
8. Recap the reagent bottles between uses.
• 20/40 reaction discs
• 20/40 extraction tubes
• 20/40 sterile Polyester (Dacron) tipped swabs
• One package insert
Store at 2-30°C. Do not use after the expiry date.
End of Assay
Window
2
EN
TP Strep A ROW 240599R4_4.indd 1 2011/08/12 11:12:41