Gima STREP-A TEST User guide

ENGLISH

PACKAGE INSERT

A rapid test for the qualitative detection of Strep A antigens in throat
swab specimens. For near-patient and laboratory professional in vitro
diagnostic use only.

INTENDED USE

The Strep A Rapid Test is a rapid chromatographic immunoassay for the
qualitative detection of Strep A antigens in throat swab specimens. The
Strep A Rapid Test is for near-patient and laboratory professional in vitro
diagnostic use only and is intended to be used as an aid in the diagnosis
of Group A Streptococcal infections.
The test provides preliminary test results, negative results will not preclude
Strep A infection and they can’t be used as the sole basis for treatment or
other management decision.
Not for Self-testing use.

SUMMARY

Streptococcus pyogenes is non-motile gram-positive cocci, which contains

the Lanceeld group A antigens 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 identication procedures for Group A Streptococci
infection involve the isolation and identication of viable organisms using

techniques that require 24 to 48 hours or longer.3
The Strep A Rapid Test is a rapid test to qualitatively detect the presence
of Strep A antigens in throat swab specimens, providing results within

5 minutes. The test utilizes antibodies specic for whole cell Lanceeld

Group A Streptococcus to selectively detect Strep A antigens in a throat
swab specimen.

PRINCIPLE

The Strep A Rapid Test a qualitative, lateral ow immunoassay for the

detection of Strep A carbohydrate antigen in a throat swab. In this test,

antibody specic 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 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 in the control line region, indicating that
proper volume of specimen has been added and membrane wicking
has occurred.

REAGENT

The test contains Strep A antibody and Biotin-BSA coated particles,
Streptavidin-Rabbit IgG and Strep A antibodies coated on the membrane.

WARNINGS AND PRECAUTIONS

Please read all the information in this package insert before performing
the test.
For near-patient and laboratory professional in vitro diagnostic use only.
Do not use after the 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 against microbiological 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 may adversely a󰀨ect results.

Do not use test if pouch is damaged. Do not split products to use.
Extraction reagent 1 contains NaNO2. If the solution contacts the skin or

eye, ush with large volumes of water.

Do not interchange reagent bottle caps.
Do not interchange external control solution bottle caps.
Wash hands thoroughly before and after handling.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority.
Components provide in the kit are approved for use in the Strep A Rapid
Test. Do not use any other commercial kit component.

STORAGE AND STABILITY

The kit can be stored 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 beyond the expiration date.
Note: It is suggested to use test strip within one hour after removing it
from the foil pouch.

SPECIMEN COLLECTION AND PREPARATION

Collect the throat swab specimen with the sterile swab that is provided in

the kit. Transport swabs containing modied Stuart’s or Amies medium

can also be used with this product. Swab the posterior pharynx, tonsils

and other inamed areas. Avoid touching the tongue, cheeks and teeth

with the swab.
Testing should be performed immediately after the specimens have been
collected. If swab are not processed immediately, it is highly recommended
the swab specimens is stored into 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 in the Strep A Rapid Test.

MATERIALS

Materials Provided

Kit size 25T/kit

Test strips 25

Package insert 1

Extraction tubes 25

Sterile swabs 25

Workstation 1

Components

Materials Required But Not Provided

- Timer

Extraction Reagent 1
10 mL (13.8% NaNO2, 0.0004%
Phenol red), Red cap

Extraction Reagent 2
10 mL (0.5184% Citric acid, 0.02% Proclin

300), Yellow cap

Positive control

0.5 mL (Non-viable Strep A, 0.02% Proclin
300, 0.5% BSA), Blue cap

Negative control

0.5 mL (Non-viable Strep C, 0.02% Proclin
300, PBS), Green cap

1

1

1

1

DIRECTIONS FOR USE

Allow the test, reagent, throat swab specimen, and/or controls to reach
room temperature (15-30°C) prior to testing.
Remove the test strip 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.
Insert the extraction tube into the workstation, 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. (See illustration 1.)
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. (See illustration 2.)
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. (See illustration 3.)
With arrows pointing down, place the test strip into the tube of solution
and then start the timer. If the procedure is followed correctly, the liquid

should be at or just below the maximum line (MAX) on the test strip. (See

the illustration 4.)

Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not
interpret the result after 10 minutes. (See illustration 5.)
Note: It is suggested not to use the Extraction Reagent 1 and Extraction
Reagent 2 beyond 6 months after opening the vial.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)
POSITIVE:* Two colored lines appear. One colored line should be in
the control line region (C) and another colored line should be in the test
line region (T). A positive result indicates that Strep A was 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 present in the specimen.
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 conrm 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. Insu󰀩cient 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 kit immediately and
contact your local distributor.

QUALITY CONTROL

Internal Quality Control

Internal procedural controls are included in the test. A colored line
appearing in the control region (C) is an internal procedural control. It

conrms su󰀩cient specimen volume, adequate membrane wicking and

correct procedural technique.

External Quality Control

It is recommended that a positive and negative external control be run
every kit, 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

Add 4 full drops of Extraction Reagent 1 and 4 full drops of Extraction
Reagent 2 into an extraction tube. Tap the bottom of the tube gently to
mix the liquid.
Add 1 full drop of positive or negative control solution into the tube, holding
the bottle upright.
With arrows pointing down, place the test into the tube of solution and then
start the timer. If the procedure is followed correctly, the liquid should be at

or just below the maximum line (MAX) on the test. See the illustration 4.

Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not
interpret the result after 10 minutes. See illustration 5.
If the controls do not yield the expected results, do not use the test results.
Repeat the test or contact your distributor.
Note: The POSITIVE CONTROL and NEGATIVE CONTROL are qualitative
reagents and are not to be used as quantitative calibrators. This control
can only be used to validate the performance of Strep A Rapid Test
manufactured by the company.

LIMITATIONS

The Strep A Rapid Test 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.
This test will only indicate the presence of Strep A antigen in the specimen
from both viable and non-viable Group A Streptococcus bacteria.

A negative result should be conrmed 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.
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 teeth4 and any bleeding areas of the mouth with the
swab when collecting specimens.
As with all diagnostic tests, all results must be interpreted together with
other clinical information available to the physician.

PERFORMANCE CHARACTERISTICS

Accuracy

Clinical test has been conducted on altogether 361 throat swab Specimens.
The tests were parallel comparison studied with the culture.
For the Field user study, 103 specimens were found to be positive by
culture and 99 were also positive by the Strep A Rapid Test; 258 specimens
were found to be negative by culture and 252 were also negative by the
Strep A Rapid Test. Based on this data, the Accuracy is 97.2% for the
Strep A Rapid Test.
For the Professional study, 103 specimens were found to be positive by
culture and 99 were also positive by the Strep A Rapid Test; 258 specimens
were found to be negative by culture and 252 were also negative by the
Strep A Rapid Test. Based on this data, the Accuracy is 97.2% for the
Strep A Rapid Test.

Method
Comparison

Strep A

Positive 99 6 105 99 6 105

Rapid

Negative 4 252 256 4 252 256

Test

Total 103 258 361 103 258 361

Relative
sensitivity

Relative

specicity

Accuracy 97.2%

*Condence Intervals

Field User Professional

Culture Total Culture Total

Positive Negative Positive Negative

96.1%

(95%CI*: 90.4%-98.9%)

97.7%

(95%CI*: 95.0%-99.1%)

(95%CI*: 95.0%-98.7%)

96.1%

(95%CI*: 90.4%-98.9%)

97.7%

(95%CI*: 95.0%-99.1%)

97.2%

(95%CI*: 95.0%-98.7%)

Sensitivity

ENGLISH

The Strep A Rapid Test can detect levels of Strep A as low as 1E+07 org/
mL (1E+05 org/test).

Hook

There is no dose hook e󰀨ect with the test, when the Strep A level is no

more than 1E+12 org/mL (1E+10 org/test).

Precision

Precision has been determined by using seven specimens: 0.5% BSA­PBS negative specimen, 5E+06 org/ml, 1E+07 org/mL, 1.5E+07 org/
mL, 2E+07 org/mL,

2.5E+07 org/mL, 1E+08 org/mL positive specimens. The study was

performed 6 replicates per day for 5 consecutive days in 3 di󰀨erent sites

using 3 separate lots of Strep A Rapid Test (one lot per site), and three
operators per site. The precision results got high accuracy at 0.5% BSA­PBS, 5E+06 org/mL, 1E+07 org/mL, 1.5E+07 org/mL, 2E+07 org/mL,

2.5E+07 org/mL, 1E+08 org/mL.

Cross Reactivity

The following organisms were tested at 1E+07org/mL and were all found to
be negative when tested with the Strep A Rapid Test. No mucoid-producing
strains were tested.

Group B
Streptococcus

Group F
Streptococcus

Streptococcus
pneumoniae

Streptococcus
mutans

Staphylococcus
aureus

Corynebacterium
diphtheria

Candida albicans Staphylococcus

Enterococcus faecalis

Neisseri a meningitidis Serratia

Neisseria sicca Klebsiella

Branhamella
catarrhalis

Group C
Streptococcus

Group G
Streptococcus

Streptococcus
sanguis

epidermidis

marcescens

pneumoniae

Bordetella pertussis

Neisseria
gonorrhea

Neisseria subava

Hemophilus

inuenza

Pseudomonas
aeruginosa

Index of Symbols

Manufacturer Imported by

Lot number Product code

In vitro diagnostic medical device compliant
with Regulation (EU) 2017/746

Don’t use if package is damaged Consult instructions for use

Expiration date Disposable device, do not re-use

Σ

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

Contains su󰀩cient for <n> test Temperature limit

In vitro diagnostic medical device Warning

Unique device identier

Authorized representative in the
European community

Interfering Substances

The following compounds have also been tested using the Strep A Rapid
Test and no interference was observed.

Cherry Halls cough drops Vicks Chloraseptic spray

Menthol Halls cough drops Cepacol Chloraseptic spray

Robitussin cough syrup Listerine mouthwash

Dimetapp cough syrup Scope mouthwash

BIBLIOGRAPHY

Murray, P.R., et al. Manual of Clinical Microbiology, 6th Edition, ASM Press,

Washington D.C., 1995, p. 299-307.
Webb, KH. Does Culture Confirmation of High-sensitivity Rapid

Streptococcal Tests Make Sense? A Medical Decision Analysis. Pediatrics

(Feb 1998), 101:2, 2.

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.

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

PROFESSIONAL MEDICAL PRODUCTS

STREP A RAPID TEST

IST-N501 (GIMA 24521)

Hangzhou AllTest Biotech Co., Ltd.
#550, Yinhai Street
Hangzhou Economic & Technological Development Area
Hangzhou - 310018, P.R. China
Made in China

MedNet EC-REP GmbH
Borkstrasse 10 - 48163
Muenster, Germany

Gima S.p.A.

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

www.gimaitaly.com

M24521-Rev.0-03.23

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