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PrintProduct Name: Strep A Rapid Test 
Product Categories: Medical Equipment Manufacturing Equipment Post Date: Mar 28,2016 Expiry Date: Mar 28,2017 Description: Payment Method: T/T,Western union
NEUTRAL PACKING: spanbio
NegotiableUSD/Metric Tons
Strep A Format:Strip,Cassette,Uncut sheet
Strep A buffers:Reagent A and Reagent B
A rapid test for the qualitative detection of Strep A
antigen in throat swab specimens. For professional in vitro
diagnostic use only.
Sterp A INTENDED USE
The Strep A Rapid Test Cassette (Throat Swab) is a rapid
chromatographic immunoassay for the qualitative detection of
Strep A
antigen from throat swab specimens to aid in the diagnosis
of Group A Streptococcal infection.
Strep A SUMMARY
Streptococcus pyogenes is non-motile gram-positive cocci,
which contains the Lancefield group A antigen that can cause
serious
infections such as pharyngitis, respiratory infection,
impetigo,endocarditis, meningitis, puerperal sepsis, and
arthritis.1 Left untreated,
these infections can lead to serious complications,
including rheumatic fever and peritonsillar abscess.2
Traditional identification
procedures for Group A Streptococci infection involve the
isolation and identification of viable organisms using
techniques that require
24 to 48 hours or longer.3,4
The Strep A Rapid Test Cassette (Throat Swab) is a rapid
test to qualitatively detect the presence of Strep A antigen
in throatswab
specimens, providing results within 5 minutes. The test
utilizesantibodies specific for whole cell Lancefield Group
A Streptococcus to
selectively detect Strep A antigen in a throat swab
specimen.
Sterp A PRINCIPLE
The Strep A Rapid Test Cassette (Throat Swab) is a
qualitative, lateral flow immunoassay for the detection of
Strep A carbohydrate
antigen in a throat swab. In this test, antibody specific to
Strep A carbohydrate antigen is coated on the test line
region of the test.
After the test strip is immersed into a specimen, the
extracted throat swab specimen reacts with an antibody to
Strep A that iscoated
onto particles. This mixture migrates up the membrane to
react with the antibody to Strep A on the membrane and
generate a colored
line in the test line region. The presence of this colored
line in the test line region indicates a positive result,
while its absence
indicates a negative result. To serve as a procedural
control, a colored line will always appear at the control
line region, indicating that
proper volume of specimen has been added and membrane
wicking has occurred.
Materials Provided
Test Cassettes
Strep A Reagent A (2M Sodium Nitrite)
Strep A Reagent B (0.4M Acetic Acid)
Sterile swabs
Workstation
Package insert
Test tubes
Materials Required But Not Provided
Timer
Strep A PRECAUTIONS
1. For professional in vitro diagnostic use only. Do not
use after expiration date.
2. Do not eat, drink or smoke in the area where the
specimens and kits are handled.
3. Handle all specimens as if they contain infectious
agents. Observe established precautions against
microbiological hazards
throughout the procedure and follow the standard procedures
for proper disposal of specimens.
4. Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are
assayed.
5. Humidity and temperature can adversely affect results.
6. Do not use test if pouch is damaged.
7. Reagent B contains an acidic solution. If the solution
contacts the skin or eye, flush with large volumes of water.
8. The positive and negative controls contain sodium azide
(NaN3) as a preservative.
9. Do not interchange reagent bottle caps.
10. Do not interchange external control solution bottle
caps.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature or
refrigerated (2-30°C). The test strip is stable through the
expiration
date printed on the sealed pouch. The test strip must remain
in the sealed pouch until use. DO NOT FREEZE. Do not use
after the
expiration date.
Strep A SPECIMEN COLLECTION AND PREPARATION
1. Only use reagents and sterile swabs provided in the kit.
2. Collect the throat swab specimen with the sterile swab
that is provided in the kit. Swab the posterior pharynx,
tonsils and other
inflamed areas. Avoid touching the tongue, cheeks and teeth
with the swab.5
3. Testing should be performed immediately after the
specimens have been collected. Swab specimens may be stored
in a clean,
dry plastic tube for up to 8 hours at room temperature or 72
hours at 2-8°C. Transport swabs containing modified
Stuart’s or
Amies medium?can also be used with this product.
4. If a culture is desired, lightly roll the swab tip onto
a Group A selective (GAS) blood agar plate before using the
swab with the
Strep A Rapid Test Cassette (Throat Swab).
Strep A DIRECTIONS FOR USE
Allow the test device, specimen, reagents, and/or controls
to reach room temperature (15-30°C) prior to testing.
1. Remove the test device from the sealed foil pouch and use
it as soon as possible. Best results will be obtained if the
test is
performed immediately after opening the foil pouch.
2. Hold the Reagent A bottle vertically and add4 full drops
(approximately 240 uL)of Reagent A to an extraction test
tube.
Reagent A is red in color. Hold the Reagent B bottle
vertically and add 4 full drops (approximately 160 uL)of
Reagent B. Reagent B
is colorless. Mix the solution by gently swirling the
extractiontest tube. The addition of Reagent B to Reagent A
changes the color of
the solution from red to yellow.
3. Immediately add the throat swab into the extraction test
tube of yellow solution. Agitate the swab by rotating it at
least 10 times.
Leave the swab in the extraction test tube for 1 minute.Then
express the liquid from the swab head by rolling the swab
against the
inside of the tube and squeezing the tube as the swab is
withdrawn. Discard the swab.
4. Fit the dropper tip on top of the extraction test tube.
Place the test device on a clean and level surface. Add 3
full dropsof solution
(approx. 100 μL) to the specimen well (S) and then start
the timer.
5. Wait for the colored line(s) to appear. Read the result
at 5 minutes. Do not read the result after 10 minutes...
Strep A Relative Sensitivity: 94% (88%â€98%)*
Strep A Relative Specificity: 98% (96%â€99%)*
Strep A Accuracy: 97% (96%â€98%)* * 95% Confidence Intervals
Contact Rebecca Yan
Skype: span.biotech
Email: rebecca@spanbio.com
anna.lee@spanbio.com
Tel: +86(755)89589611
Fax: +86(755)89580096
Web:www.spanbio.com
www.spanbiotech.com
Company: Span Biotech Ltd. [ Guangdong ] Address: Room 6A,Unit 5, Building 3, Sunshine Aloha, Bantian Industrial Park, Banxuegang Road ,Longgang Shenzhen Contact: Rebecca Yan Tel: 0755-89589611 Mobile: Fax: 0755-89580096 Email: rebecca@spanbio.com Disclaimer statement:The information and data included above have been realized by the enterprises and compiled by Department staff, and are subject to change without notice to you. The ChinameDevice.com makes no warranties or representations whatsoever regarding the facticity, accuracy and validity of such information and data. Our suggestion: In order to ensure your interest, we suggest registering as our gold suppliers.
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