Strep A Test Cassette
REF FI-STA-502
English
Test Cassettes
Extraction Tubes
Sterile Swabs
Workstation
Package Insert
Dropper tips
Extraction Reagent 1 (2M NaNO2)
Extraction Reagent 2 (0.027M Citric acid)
ID Card
Timer
Pipette
Fluorescence Immunoassay Analyzer
Index of Symbols
Consult instructions
electronic instructions
for use
In vitro diagnostic
medical device
Catalogue
number
Authorized
European Community
Do not use if package
consult instructions for
use
Hangzhou AllTest Biotech Co., Ltd.
MedNet EC-REP GmbH
Borkstrasse 10
48163 Muenster
Germany
(Throat Swab)
Package Insert
A Fluorescence Immunoassay test kit for the qualitative detection of Strep A Antigen in
throat swab specimens with the use of Fluorescence Immunoassay Analyzer.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Strep A Test Cassette (Throat swab) is intended for in vitro detection of strep A
antigens in throat swab specimens. It is intended to aid in the rapid differential diagnosis
of strep A viral infections.
【SUMMARY】
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the
Lancefield group A antigens that can cause serious infections such as pharyngitis,
respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.
Left untreated, these infections can lead to serious complications, including rheumatic
fever and peritonsillar abscess.
Streptococci infection involve the isolation and identification of viable organisms using
techniques that require 24 to 48 hours or longer.
The Strep A Test Cassette is a test to qualitatively detect the presence of Strep A
antigens in throat swab specimens, providing results within 15 minutes. The test utilizes
antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect
Strep A antigens in a throat swab specimen.
【
PRINCIPLE】
The Strep A Test Cassette (Throat Swab) detects Strep A carbohydrate antigen in a
throat swab based on Fluorescence Immunoassay. In this test, antibody specific to Strep
A carbohydrate antigen is coated on the test line region of the test. During testing, the
extracted throat swab specimen reacts with an antibody to Strep A that is coated onto
particles. The mixture migrates up the membrane to react with the antibody to Strep A on
the membrane. If the specimen contains Strep A antigen, it attaches to the fluorescent
microspheres-conjugated Strep A antibodies. Then the complex will be captured by the
capture antibodies coated on the nitrocellulose membrane (Test line). The concentration
of Strep A in the sample correlates with the fluorescence signal intensity captured on the
T line， which can be scanned by Fluorescence Immunoassay Analyzer. The testing
result of Strep A will display on the Fluorescence Immunoassay Analyzer screen.
REAGENT】
【
The test contains Strep A antibody coated particles and Strep A antibodies coated on the
membrane.
PRECAUTIONS】
【
1. For professional in vitro diagnostic use only. Do not use after the 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. The used test should be discarded according to local regulations.
6. Humidity and temperature can adversely affect results.
7. Do not use test if pouch is damaged.
8. Reagent 2 contains an acidic solution. If the solution contacts the skin or eye, flush
with large volumes of water.
9. Do not interchange reagent bottle caps.
10. Do not interchange external control solution bottle caps.
11. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
12. Read the entire procedure carefully prior to any testing.
13. The Strep A Test Cassette is only operational in the Analyzer. And tests should be
applied by professionally trained staff working in certified laboratories at some
remove from the patient and clinic at which the sample(s) is taken by qualified
medical personnel
STORAGE AND STABILITY】
【
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false results.
SPECIMEN COLLECTION AND PREPARATION】
【
1. Collect the throat swab specimen with the sterile swab that is provided in the kit.
Transport swabs containing modified Stuart’s or Amies medium can also be used with
this product. Swab the posterior pharynx, tonsils and other inflamed areas. Avoid
touching the tongue, cheeks and teeth with the swab.
2. Testing should be performed immediately after the specimens have been collected.
2
Traditional identification procedures for Group A
3.4
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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.
3. If a culture is desired, lightly roll the swab tip onto a Group A selective (GAS) blood
agar plate before using the swab in the Strep A Test Cassette (Throat Swab).
MATERIALS】
【
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete
instructions on use of the Test. The test should be conducted in room temperature.
1
Allow the test, reagents, throat swab specimen, and/or controls to reach room
temperature (15-30℃
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best
results will be obtained if the test is performed immediately after opening the foil
pouch.
2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately
240 μL) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in
color. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops
(approximately 160 μL) to the tube. Extraction Reagent 2 is colorless. Mix the
solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to
Extraction Reagent 1 changes the color of the solution from red to yellow.
3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15
times, and leave the swab in the extraction test tube for 1 minute.
4. Press the swab against the side of the tube and squeeze the bottom of the tube while
removing the swab so that most of the liquid stays in the tube. Discard the swab.
5. Place the test cassette on a clean and level surface. Add three drops of the solution
(approx.120ul) to the sample well. Start the timer at the same time.
6. There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test
mode and Quick Test mode. Please refer to the user manual of Fluorescence
Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample，Insert the test cassette into the
Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After
the countdown, the Analyzer will give the result at once.
【
INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for Strep A is calculated by Fluorescence Immunoassay Analyzer and
display the result on the screen. For additional information, please refer to the user
manual of Fluorescence Immunoassay Analyzer.
NOTE: The test result of each specimen is given as Pos (+) or Neg (-) with a
Reference Value. This Value is calculated that a measured signal is divided by an
appropriate cutoff value.
- Test results of a Value ≥ 1.00 are considered positive.
- Test results of a Value < 1.00 are considered negative.
QUALITY CONTROL】
【
Each Strep A Test Cassette contains internal control that satisfies routine quality control
Materials Provided
Materials Required But Not Provided
) prior to testing.
requirements. This internal control is performed each time a sample is tested. This
control indicates that the test cassette was inserted and read properly by Fluorescence
Immunoassay Analyzer. An invalid result from the internal control causes an error
message on Fluorescence Immunoassay Analyzer indicating that the test should be
repeated. An invalid result from the internal control causes an “N/A” message on
Fluorescence Immunoassay Analyzer. Insufficient specimen volume or incorrect
procedural techniques are the most likely reasons for control failure. Review the
procedure and repeat the test with a new test. If the problem persists, discontinue using
the test kit immediately and contact your local distributor.
【
LIMITATIONS】
1. The Strep A Test Cassette (Throat Swab) is for in vitro diagnostic use only. The test
should be used for the detection of Strep A antigen in throat swab specimens only.
Neither the quantitative value nor the rate of increase in Strep A antigen concentration
can be determined by this qualitative test.
2. This test will only indicate the presence of Strep A antigen in the specimen from both
viable and non-viable Group A Streptococcus bacteria.
3. A negative result should be confirmed by culture. A negative result may be obtained if
the concentration of the Strep A antigen present in the throat swab is not adequate or
is below the detectable level of the test.
4. Excess blood or mucus on the swab specimen may interfere with test performance
and may yield a false positive result. Avoid touching the tongue, cheeks, and teeth
and any bleeding areas of the mouth with the swab when collecting specimens.
5. As with all diagnostic tests, all results must be interpreted together with other clinical
information available to the physician.
【
EXPECTED VALUES】
Approximately 15% of pharyngitis in children ages 3 months to 5 years is caused by
Group A beta hemolytic Streptococcus.
incidence of Strep throat infection is about 40%.
winter and early spring in temperate climates.
BIBLIOGRAPHY】
【
1. Murray, P.R., et al. Manual of Clinical Microbiology, 6th Edition, ASM Press,
Washington D.C., 1995, p. 299-307.
2. Webb, KH. Does Culture Confirmation of High-sensitivity Rapid Streptococcal Tests
Make Sense? A Medical Decision Analysis. Pediatrics (Feb 1998), 101:2, 2.
3. Bisno AL, Gerber MA, Gwaltney JM, Kaplan EL, Schwartz RH. Diagnosis and
Management of Group A Streptococcal Pharyngitis. Clinical Infectious Diseases
(1997), 25: 574-83.
4. Needham CA, McPherson KA, Webb KH. Streptococcal Pharyngitis: Impact of a
High-sensitivity Antigen Test on Physician Outcome. Journal of Clinical Microbiology
(Dec 1998), 36: 3468-3473.
5. Shea, Y.R., Specimen Collection and Transport, Clinical Microbiology Procedures
Handbook, Isenberg, H.D., American Society of Microbiology, Washington D.C.,
1.1.1-1.1.30, 1992.
6. Nussinovitch, M, Finkelstein Y, Amir J, Varsano, I. Group A beta-hemolytic
streptococcal pharyngitis in preschool children aged 3 months to to 5 years. Clinical
Pediatrics (June 1999), 38: 357-360.
7. Woods WA, Carter CT, Stack M, Connors Jr AF, Schlager TA. Group A Streptococcal
Pharyngitis in Adults 30 to 65 years of age. Southern Medical Journal (May 1999),
491-492.
for use or consult
6
In school-aged children and adults, the
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This disease usually occurs in the
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Contains
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Batch code
representative in the
is damaged and
Statement: Information about manufacturer of sterile swab is placed on the packaging.
Distributed in Italy by PM2 Services Srl, Corso Mazzini 38- Largo Marchi, 36071
Arzignano (VI) - info@pm2services.it
Number: F145106400
Revision date: 2022-09-14
Use-by date
Do not re-use
Manufacturer
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