Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
www.gimaitaly.com
CARD PER TEST STREP A RAPID TEST (TAMPONE FARINGEO)
STREP A RAPID TEST DEVICE (THROAT SWAB)
CASSETTE TEST RAPIDE STREP A (PRÉLÈVEMENT DE GORGE)
STREP A SCHNELLTEST-KASSETTE (HALS-/RACHENABSTRICH)
PRUEBA RÁPIDA DE STREP A EN PLACA (FROTIS DE GARGANTA)
DISPOSITIVO PARA TESTE RÁPIDO DE ESTREPTOCOCOS A
(COTONETE DE GARGANTA)
ΣΎΣΤΗΜΑ ΤΑΧΕΊΑΣ ΕΞEΤΑΣΗΣ STREP A
(ΛΑΡΎΓΓΊΚΟΎ ΕΚΚΡIΜΑΤΟΣ)
Manuale d’uso - User manual
Manuel de l’utilisateur - Gebrauchsanweisung
Guía de Uso - Guia para utilização - Οδηγίες χρήσης
PER USO PROFESSIONALE
FÜR DEN PROFESSIONELLEN GEBRAUCH
FOR PROFESSIONAL USE
PARA USO PROFESIONAL
PARA USO PROFISSIONAL
ΓΙΑ ΕΠΑΓΓΕΛΜΑΤΙΚΗ ΧΡΗΣΗ
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre
ce manuel avant d’utiliser le produit.
ACHTUNG: Die Bediener müssen vorher dieses Handbuch
gelesen und verstanden haben, bevor sie das Produkt benutzen.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
24522
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
M24522-M-Rev.4-11.19
Made in P.R.C.
30°C
2°C
20
6
A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.For
professional in vitro diagnostic use only.
The Strep A Rapid Test Device (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.
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. Left untreated, these infections can lead to serious complications, including
rheumatic fever and peritonsillar abscess. 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.
The Strep A Rapid Test Device (Throat Swab) is a rapid test to qualitatively detect the presence of Strep A
antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for
whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.
The Strep A Rapid Test Device (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. 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 and generate a color line in the test line region. The presence of this
color 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 in the control line region, indicating that
proper volume of specimen has been added and membrane wicking has occurred.
The test contains Strep A antibody coated particles and Strep A antibody coated on the membrane.
- For professional in vitro diagnostic use only. Do not use after expiration date.
- Do not eat, drink or smoke in the area where the specimens and kits are handled.
- Handle all specimens as if they contain infectious agents. Observe established precautions
againstmicrobiological hazards throughout the procedure and follow the standard procedures for proper
disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens
are assayed.
- The used test should be discarded according to local regulations.
- Humidity and temperature can adversely affect results.
- Do not use test if pouch is damaged.
- Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes of
water.
- The positive and negative controls contain sodium azide (NaN3) as a preservative.
- Do not interchange reagent bottle caps.
- Do not interchange external control solution bottle caps.
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable
through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
DO NOT FREEZE. Do not use after the expiration date.
- 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.
- 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.
- 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 Device (Throat Swab).
Strep A Rapid Test Device (Throat Swab) Package Insert
INTENDED USE
SUMMARY
PRINCIPLE
REAGENTS
PRECAUTIONS
STORAGE AND STABILITY
SPECIMEN COLLECTION AND PREPARATION
7
MATERIALS
- Test devices - Dropper tips - Test tubes
- Sterile swabs - Strep A Reagent A - Strep A Positive control
- Workstation - Strep A Reagent B - Strep A Negative control
- Package insert (0.2M Acetic Acid) (Non-viable Strep C; 0.09% NaN3)
- Timer
Allow the test, reagents, throat swab specimen, 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
extraction test tube. Reagent A is red in color. Hold the Reagent B bottle vertically and add 4 full drops
(approximately 160 µL) to the tube. Reagent B is colorless. Mix the solution by gently swirling the
extraction test tube. The addition of Reagent B to Reagent A changes the color of the solution from red to
yellow. See illustration 1.
3) Immediately add the throat swab to the extraction test tube of yellow solution. Agitate the swab 10
times in the tube. Leave the swab in the tube for 1 minute. Then press the swab against the side of the tube
and squeeze the bottom of the tube as the swab is withdrawn. Discard the swab. See illustration 2.
4) Fit the dropper tip on top of the
3 full drops of solution (approx. 100 µL) to the specimen well (S) and then start the timer. See illustration 3.
5) Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not read the result after 10 minutes.
(2M Sodium Nitrite) (Non-viable Strep A; 0.09% NaN3)
Materials Required But Not Provided
extraction test tube. Place the test device on a clean and level surface. Add
Materials Provided
DIRECTIONS FOR USE
add 4 full drops (approximately 240 µL) of Reagent A to an
INTERPRETATION OF RESULTS
3 Drops of solution
Positive Negative Invalid
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another
apparent colored line should be in the test line region (T). A positive result indicates that Strep A antigen is
detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of
Strep A antigen present in the specimen. Therefore, any shade
considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line
region (T). A negative result indicates that Strep A antigen is not present in the specimen, or is present below
the detectable level of the test. The patient’s specimen should be cultured to confirm the absence of Strep
A infection. If clinical symptoms are not consistent with results, obtain another specimen for culture.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test.
If the problem persists, discontinue using the test immediately and contact your local distributor.
of color in the test line region (T) should be
8
QUALITY CONTROL
Internal procedural controls are included in the test. A colored line appearing in the control line region (C)
is an internal positive procedural control. It confirms sufficient specimen volume, adequate membrane
wicking and correct procedural technique.
It is recommended that a positive and negative external control be run every 25 tests, and as deemed
necessary by internal laboratory procedures. External positive and negative controls are supplied in the kit.
Alternatively, other Group A and non-Group A Streptococcus reference strains may be used as external
controls. Some commercial controls may contain interfering preservatives; therefore, other commercial
controls are not recommended.
Procedure for External Quality Control Testing
1) Add 4 full drops of Reagent A and 4 full drops of Reagent B into an extraction test tube. Mix the solution
by gently swirling the extraction tube.
2) Add 1 full drop of positive or negative control solution into the extraction tube, holding the bottle
vertically.
3) Place a clean swab into this extraction tube and agitate the swab in the solution by rotating it at least 10
times. Leave the swab in the extraction tube for 1 minute. Then express the liquid from the swab head by
rolling the swab against the inside of the extraction tube and squeezing the extraction tube as the swab is
withdrawn. Discard the swab.
4) Continue with Step 4 of Directions For Use.
If the controls do not yield the expected results, do not use the test results. Repeat the test or contact your
distributor.
Internal Quality Control
External Quality Control
1) The Strep A Rapid Test Device (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 antig en in the specimen from both viable and nonviable 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 teeth5 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.
PERFORMANCE CHARACTERISTICS - Sensitivity and Specificity
Using three medical centers for evaluation, a total of 492 throat swabs were collected from patients
exhibiting symptoms of pharyngitis. Each swab was rolled onto a sheep blood agar plate, and then tested
by the Strep A Rapid Test Device (Throat Swab). The plates were further streaked for isolation, and then
incubated at 37° C with 5-10% CO2 and a Bacitracin disk for 18-24 hours. The negative culture plates were
incubated for an additional 18-24 hours. Possible GAS colonies were subcultured and confirmed with a
commercially available latex agglutination grouping kit.
Of the 492 total specimens, 384 were confirmed to be negative and 108 were confirmed to be positive by
culture. During this study, two Strep F specimens yielded positive results with the Test. One of these
specimens was re-cultured, then re-tested and yielded a negative result. Three additional different Strep F
strains were cultured and tested for cross-reactivity and also yielded negative results.
LIMITATIONS
9
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Relative Sensitivity: 94% (88%-98%)* Relative Specificity: 98% (96%-99%)*
Accuracy: 97% (96%-98%)* * 95% Confidence Intervals
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stluseRlatoTstluseRlatoT 801483294
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latoTlatoT
latoT
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The following organisms were tested at 1,0 x 107 organisms per test and were all found to be negative when
tested with the Strep A Rapid Test Device (Throat Swab). No mucoid-producing strains were
tested.
Group B Streptococcus Neisseria meningitidis Serratia marcescens
Group F Streptococcus Neisseria sicca Klebsiella pneumoniae
Streptococcus pneumoniae Branhamella catarrhalis Bordetella pertussis
Streptococcus mutans Group C Streptococcus Neisseria gonorrhea
Staphylococcus aureus Group G Streptococcus Neisseria subflava
Corynebacterium diphtheria Streptococcus sanguis Hemophilus influenza
Candida albicans Enterococcus faecalis
Pseudomonas aeruginosa Staphylococcus epidermidis
Cross-Reactivity
Leggere le istruzioni per
lʼuso
Consult instructions for use
Dispositivo medico-diagnostico in vitro
In vitro diagnostic medical
device
30°C
Conservare tra 2 e 30°C
2°C
Store between 2 and 30°C
Conservare in luogo
fresco ed asciutto
Keep away from sunlight
Conservare in luogo fresco
ed asciutto
Keep in a cool, dry place
Contiene <n> di test
Σ
Contains sufcient
for “n” tests
Dispositivo monouso,
non riutilizzare
Disposable device,
do not re-use
Tamponi sterili / Sterile swabs:
Puritan Medical Products Company LLC
31 School Street
Guilford, ME 04443-0149, U.S.A.
Simbologia / Index of symbols - TEST
Data di scadenza
Expiration date
Numero di lotto
Lot number
Attenzione: Leggere
e seguire attentamente
le istruzioni (avvertenze)
per l’uso
Caution: read instructions
(warnings) carefully
Rappresentante autorizzato
nella Comunità europea
Authorized representative
in the European community
Sterilizzato con
ossido di etilene
Sterilized using
ethylene oxide
Dispositivo medico
conforme alla Direttiva
93/42/CEE
Medical Device complies
with Directive 93/42/EEC
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague,
The Netherlands
32
Codice prodotto
Product code
Fabbricante
Manufacturer
Tossicità acuta di grado 4”
Tenere fuori dalla portata dei bambini.
Indossare guanti e indumenti protettivi,
protezione per gli occhi e viso. In caso
di ingerimento consultare un medico
o rivolgersi ad un centro ospedaliero.
In caso di contatto con gli occhi, lavare
immediatamente ed abbondantemente
con acqua per diversi minuti. Rimuovere le lenti a contatto, nel caso siano
presenti, e continuare a sciacquare
gli occhi. Se l’irritazione dovesse
persistere consultare un medico.
Acute toxicity category 4
Keep out of the reach of children.
Wear protective gloves/protective
clothing/eye protection/face protection.
IF SWALLOWED: Call a POISON
CENTRE or doctor/physician if you
feel unwell.
IF IN EYES: Rinse cautiously
with water for several minutes.
Remove contact lenses, if present
and easy to do.
Continue rinsing. If eye irritation
persists, get medical advice/attention.
0086
Bibliografia / 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, Cart
age. Southern Medical Journal (May 1999), 491-492.
er CT, Stack M, Connors Jr AF, Schlager TA. Group A Streptococcal Pharyngitis in Adults 30 to 65 years of
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