Gima STREP-A TEST User guide

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

PROFESSIONAL MEDICAL PRODUCTS

STRISCIA PER TEST STREP A RAPID TEST (TAMPONE FARINGEO)
STREP A RAPID TEST STRIP (THROAT SWAB)
BANDELETTE TEST RAPIDE STREP A (PRÉLÈVEMENT DE GORGE)
STREP A SCHNELLTEST-STREIFEN (HALS-/RACHENABSTRICH)
PRUEBA RÁPIDA DE STREP A EN TIRA (FROTIS DE GARGANTA)
TIRA PARA TESTE RÁPIDO DE ESTREPTOCOCOS A

(COTONETE DE GARGANTA)

ΤΑΙΝΙΑ ΤΑΧΕΙΑΣ ΕΞEΤΑΣΗΣ STREP A (ΛΑΡΥΓΓΙΚΟY 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.

24523

Gima S.p.A.

Via Marconi, 1
20060 Gessate (MI) Italy

M24523-M-Rev.4-11.19

Made in P.R.C.

30°C

2°C

25

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 Strip (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 Strip (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 Strip (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 is immersed into a specimen, the extracted throat
swab specimen reacts with an antibody to Strep A that is coated 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 aprocedural 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.

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 at room temperature for up to four hours prior to testing.

Strep A Rapid Test Strip (Throat Swab) Package Insert

INTENDED USE

SUMMARY

PRINCIPLE

REAGENTS

PRECAUTIONS

STORAGE AND STABILITY

SPECIMEN COLLECTION AND PREPARATION

7

- 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 Strip (Throat Swab).

- Test strips - Package insert - Test tubes

- Sterile swabs - Strep A Reagent A - Strep A Positive control
(2M Sodium Nitrite) (Non-viable Strep A; 0.09% NaN3)

- Workstation - Strep A Reagent B - Strep A Negative control
(0.2M Acetic Acid) (Non-viable Strep C; 0.09% NaN3)

Materials Required But Not Provided

- Timer

Allow the test, reagents, and/or controls to reach room temperature (15-30°C) prior to testing.

1) Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and

use it as soon as possible.

2) Hold the Reagent A bottle vertically and add 4 full drops (approximately 240 µL) of Reagent A toan

extraction test tube. Reagent A is red in color. Hold the Reagent B bottle vertically and add 4 full drops
(approximately 160 µL) of Reagent B. Reagent B is colorless. Mix the solution bygently swirling the
extraction test tube. The addition of Reagent B to Reagent A changes the colorof the solution from red to
yellow. See illustration 1.

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. See illustration 2.

4) With arrows pointing toward the specimen, immerse the test strip vertically into the extracted specimen

solution and then start the timer. If the procedure is followed correctly, the extraction solution should not
pass the maximum line (MAX) on the test strip when the strip is immersed. See illustration 3.

5) Leave the strip in the extraction tube and wait for the colored line(s) to appear. Read results at 5 minutes.

Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

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 of color in the
test line region (T) should be 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.

MATERIALS

Materials Provided

DIRECTIONS FOR USE

Positive Negative Invalid

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.

1) The Strep A Rapid Test Strip (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 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.

Internal Quality Control

External Quality Control

LIMITATIONS

Using three medical centers for evaluation, a total of 499 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 Strip (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 499 total specimens, 375 were confirmed to be negative and 124 were confirmed to be positive by
culture. During this study, two Strep F specimens yielded positive results on the test. One of these specimens
was re-cultured, 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.

PERFORMANCE CHARACTERISTICS - Sensitivity and Specificity

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9

Relative Sensitivity: 97% (91%-99%)* Relative Specificity: 95% (92%-97%)*
Accuracy: 95% (93%-97%)* * 95% Confidence Intervals

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noitacifissalCerutluCevitisoP

eraR11/01%19
+19/9%001
+291/71%98
+373/63%79
+484/84%001

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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 Strip (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 sufcient

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, 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.