GIMA M24520EN Strep A Rapid Test Instructions

: August 22, 2024
: GIMA

Table of Contents

M24520EN Strep A Rapid Test
Specifications
Product Usage Instructions
Warnings and Precautions
Specimen Collection and Preparation
Materials Provided
Directions for Use
Limitations
- FAQ
Q: Can I use the test beyond the expiration date?
Q: How should I store the test?

M24520EN Strep A Rapid Test

“`html

Specifications

The Strep A Rapid Test 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 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

Test type: Rapid test
Target: Strep A antigens
Intended use: Qualitative detection in throat swab
specimens
For: Near-patient and laboratory professional in vitro
diagnostic use only

Product Usage Instructions

Warnings and Precautions

Store the test in the sealed pouch until use. Do not freeze. Use
the test before the expiration date. Use the test cassette within
one hour after removing it from the foil pouch.

Specimen Collection and Preparation

Collect the throat swab specimen using the sterile swab provided
in the kit. Insert the swab into the posterior pharynx and
tonsillar areas. Rub the swab over both tonsillar pillars.

Materials Provided

Test cassettes: 20
Extraction tubes: 20
Sterile swabs: 20
Workstation: 1
Dropper tips: 20

Directions for Use

Add 3 drops of Reagent 2 into an extraction tube and mix
gently.
Add 1 full drop of positive or negative control solution into
the tube.
Fit the dropper tip on top of the extraction tube.
Place the test on a clean surface and read the result at 5
minutes. Do not interpret after 10 minutes.

Limitations

The test is for in vitro diagnostic use only.
The test detects Strep A antigen in throat swab specimens.
A negative result should be confirmed by culture.
Excess blood or mucus on the swab may interfere with test
performance.
Results must be interpreted with other clinical information
available to the physician.

FAQ

Q: Can I use the test beyond the expiration date?

A: No, it is not recommended to use the test beyond the
expiration date printed on the sealed pouch.

Q: How should I store the test?

A: Store the test in the sealed pouch, do not freeze it, and use
it within one hour after removing it from the foil pouch.

“`

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 Lancefield 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 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.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 specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigens in a throat swab specimen.
PRINCIPLE
The Strep A Rapid Test 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 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 affect results. · Do not use test if pouch is damaged. · Extraction Reagent 1 contains NaNO2. If the solution contacts the skin or eye, flush 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. Instructions for collecting a throat swab
specimen are as follows: 1. Insert swab into the posterior pharynx
and tonsillar areas. 2. Rub swab over both tonsillar pillars and
posterior oropharynx and avoid touching the tongue, teeth, and gums. 3. Withdraw the swab. Testing should be performed immediately after the specimen has been collected. If the specimen is not processed immediately, it is highly recommended the swab specimen should be stored in a clean, dry plastic tube within 8 hours at room temperature or 72 hours at 2-8 °C before test.
MATERIALS
Materials Provided

Kit size

20T/

kit

Test cassettes

20

Package insert

1

Extraction tubes

20

Sterile swabs

20

Workstation

1

Dropper tips

20

Components Extraction reagent 1

1

10 mL (13.8% NaNO2,0.0004%

Phenol red), Red cap

Extraction reagent 2

1

10 mL (0.5184% Citric acid, 0.02% Proclin

300), Yellow cap

Positive control

1

0.5 mL (Non-viable Strep A, 0.02% Proclin

300, 0.5%BSA), Blue cap

Negative control

1

0.5 mL (Non-viable Strep C, 0.02% Proclin

300,PBS), Green cap

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 L) 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 L) 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. 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. See illustration 2. 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. See illustration 3. 5. 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 L) to the sample well(S) and then start the timer.

6. 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.
3 drops of solution
Positive Negative Invalid
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 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 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 confirms sufficient 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 1. 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. 2. Add 1 full drop of positive or negative control solution into the tube, holding the bottle upright. 3. 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 L) to the sample well and then start the timer. 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
1. 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.
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.
5. 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

Field User

Professional

Culture

Total

Culture

Total

Positive Negative

Strep Positive 99

A

Rapid Negative 4

Test

Total

103

6

105 99

252 256

4

258 361 103

6

105

252 256

258 361

Relative sensitivity

96.1% (95%CI*: 90.4%-98.9%)

Relative specificity

97.7% (95%CI*: 95.0%-99.1%)

Accuracy

97.2% (95%CI*: 95.0%-98.7%)

*Confidence Intervals 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 effect 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

ENGLISH

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 different 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
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
Enterococcus faecalis

Neisseria meningitidis
Neisseria sicca
Branhamella catarrhalis
Group C Streptococcus
Group G Streptococcus
Streptococcus sanguis
Staphylococcus epidermidis

Serratia marcescens Klebsiella pneumoniae Bordetella pertussis
Neisseria gonorrhea
Neisseria subflava
Hemophilus influenza Pseudomonas aeruginosa

Cherry Halls cough drops Menthol Halls cough drops Robitussin cough syrup Dimetapp cough syrup

Vicks Chloraseptic spray Cepacol Chloraseptic spray Listerine mouthwash Scope mouthwash

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.

Index of Symbols Manufacturer
Lot number In vitro diagnostic medical device compliant with Regulation (EU) 2017/746
Don’t use if package is damaged

Expiration date

Contains sufficient for test

In vitro diagnostic medical device

Unique device identifier
GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.

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

PROFESSIONAL MEDICAL
STREP A RAPID TEST
Specimen: Throat Swab

Sterile swab
Jiangsu Changfeng Medical Industry Co., Ltd Touqiao Town, Guangling District, Yangzhou, Jiangsu 22519 China Made in China

Llins Service & Consulting GmbH Obere Seegasse 34/2, 69124 Heidelberg, Germany

IST-N502 (GIMA 24520)
Hangzhou AllTest Biotech Co., Ltd. #550, Yinhai Street Hangzhou Economic & Technological Development Area Hangzhou, 310018 P.R. China Web: www.alltests.com.cn Email: info@alltests.com.cn Made in China
MedNet EC-REP GmbH Borkstrasse 10, 48163 Muenster, Germany
Gima S.p.A. Via Marconi, 1 – 20060 Gessate (MI) Italy gima@gimaitaly.com – export@gimaitaly.com www.gimaitaly.com

Imported by
Product code Authorized representative in the European community Consult instructions for use or consult electronic instructions for use
Disposable device, do not re-use
Temperature limit
Warning

30°C 2°C

0123

M24520-Rev.1-12.23