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.
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 cassette
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

Components

Kit size 20T/

Test cassettes 20

Package insert 1

Extraction tubes 20

Sterile swabs 20

Workstation 1

Dropper tips 20

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

kit

1

1

1

1

Materials Required But Not Provided

 Timer

DIRECTIONS FOR USE

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

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. 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
Fit the dropper tip on top of the extraction tube. Place the test cassette on

a clean and level surface. Add 3 drops of the solution (approx. 100 μL) to

the sample well(S) and then start the timer.

Read the result at 5 minutes. Do not interpret the result after 10 minutes.
See illustration 4 and 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.
Fit the dropper tip on top of the extraction tube. Place the test on a clean

and level surface. Add 3 drops of the solution (approx.100 μL) to the

sample well and then start the timer.
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 96.1%

Relative specicity 97.7%

Accuracy 97.2%

*Condence Intervals

Field User Professional

Culture Total Culture Total

Positive Negative Positive Negative

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

(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

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%BSA-PBS
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%
BSA-PBS, 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

ENGLISH

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 mucoid­producing strains were tested.

Group B
Streptococcus

Group F
Streptococcus

Streptococcus
pneumoniae

Streptococcus
mutans

Staphylococcus
aureus

Corynebacterium
diphtheria

Candida albicans Staphylococcus

Enterococcus
faecalis

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

Neisseria
meningitidis

Neisseria sicca Klebsiella

Branhamella
catarrhalis

Group C
Streptococcus

Group G
Streptococcus

Streptococcus
sanguis

epidermidis

Serratia
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

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-N502 (GIMA 24520)

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

M24520-Rev.0-03.23

0123

30°C

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