AllTest Strep A Rapid Test Cassette, Throat Swab, 20 Tests: Result in 5 Minutes, for Healthcare Professionals

For healthcare professionals only. This product is intended exclusively for professional in vitro diagnostic use in medical practices, hospitals and laboratories. Not for self-testing. Sold to healthcare professionals only.

AllTest Strep A Rapid Test Cassette (Throat Swab), 20 Tests

Resolve a sore throat while the patient is still in the room: a result in 5 minutes instead of 24 to 48 hours.

The AllTest Strep A Rapid Test Cassette qualitatively detects Lancefield Group A Streptococcus antigens in throat swab specimens. It supports the diagnosis of Group A streptococcal infection directly at the point of care.

Conventional culture-based confirmation of streptococcal pharyngitis takes 24 to 48 hours or longer. This rapid test delivers the result within 5 minutes, giving you a basis for your treatment decision during the consultation itself.

Clinical background

Streptococcus pyogenes is a non-motile, gram-positive coccus carrying the Lancefield Group A antigens. It can cause serious infections including 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.

Areas of use

• General and paediatric practices seeing sore throat patients
• ENT practices
• Emergency departments and out-of-hours services
• Hospitals and outpatient clinics
• Care facilities and occupational health services
• Supporting rational antibiotic prescribing in acute pharyngitis

Key benefits

• Result in 5 minutes instead of a 24 to 48 hour culture
• High accuracy: 95.1 % relative sensitivity and 97.8 % relative specificity against culture, 97.1 % overall accuracy
• Very reliable at high bacterial load: 100 % agreement with culture for 4+ findings
• Controls included: positive and negative external quality controls are supplied in the kit, nothing to buy separately
• Internal procedural control via the control line on every individual test
• No cross-reactivity with 22 organisms tested, including Group B, C, F and G streptococci
• Detects non-viable organisms too: antigen detection works for both viable and non-viable Group A streptococci
• Flexible specimen logistics: swabs can be held for up to 8 hours at room temperature or 72 hours at 2 to 8 °C
• Transport media compatible: swabs in modified Stuart's or Amies medium can also be used
• Culture in parallel: the swab can be rolled onto a GAS blood agar plate before running the test
• Long shelf life: 24 months from manufacture
• No refrigeration required: store at 2 to 30 °C
• Complete kit for 20 tests: test cassettes, extraction tubes, reagents, sterile swabs, dropper tips and workstation
• CE-marked in vitro diagnostic medical device

Test principle

The cassette is a qualitative lateral flow immunoassay for the detection of the Group A Streptococcus carbohydrate antigen. An antibody specific to the Strep A carbohydrate antigen is coated on the test line region. The extracted swab specimen reacts with a particle-bound anti-Strep A antibody. The mixture migrates up the membrane, binds the antibody immobilised there and produces a coloured line in the test region. A coloured line always appears in the control region when the test is run correctly, confirming adequate specimen volume and membrane wicking.

Specimen collection and preparation

• Collect the throat swab with the sterile swab provided, sampling the posterior pharynx, tonsils and other inflamed areas.
• Avoid touching the tongue, cheeks and teeth with the swab.
• Testing should be performed immediately after collection. Alternatively, swab specimens may be stored in a clean, dry plastic tube for up to 8 hours at room temperature or 72 hours at 2 to 8 °C.
• If culture is also required, lightly roll the swab tip onto a Group A selective (GAS) blood agar plate before running the test.

Test procedure

Allow the test, reagents, specimen and controls to reach room temperature (15 to 30 °C) before testing.

1. Remove the test cassette from the sealed pouch and use it within one hour. Best results are obtained when the test is run immediately.
2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approx. 240 µl) to an extraction tube. Reagent 1 is red.
3. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approx. 160 µl) to the tube. Reagent 2 is colourless. Mix by gently swirling; the solution changes from red to yellow.
4. Add the swab to the tube immediately, agitate vigorously 15 times and leave it in the tube for 1 minute.
5. Press the swab against the side of the tube and squeeze the tube as you withdraw it so that most of the liquid stays behind. Discard the swab.
6. Fit the dropper tip, place the cassette on a clean level surface and add 3 drops (approx. 100 µl) to the sample well. Start the timer.
7. Read the result at 5 minutes. Do not interpret the result after 10 minutes.

Always follow the instructions for use supplied with the product.

Interpretation of results

Result	Display
Positive	Two coloured lines, one in the control region (C) and one in the test region (T). Strep A was detected in the specimen.
Negative	One coloured line in the control region (C) only. Strep A antigen is absent or below the detectable level. Culture confirmation is recommended.
Invalid	No control line. Usually caused by insufficient specimen volume or incorrect technique. Review the procedure and repeat with a new test.

The intensity of the test line varies with the antigen concentration. Any shade of colour in the test region is considered positive.

Quality control

Internal: Each cassette includes a procedural control. The coloured line in the control region confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

External: Positive and negative control solutions are supplied in the kit. To run them, add 4 drops of Extraction Reagent 1 and 4 drops of Extraction Reagent 2 to a tube, add 1 drop of control solution, rotate a clean swab in it at least 15 times, leave for 1 minute and then proceed as for a patient specimen. For the recommended frequency, refer to the instructions for use supplied with the product and to your internal laboratory procedures.

Clinical performance (manufacturer data)

A total of 526 throat swabs were collected at three medical centres from patients with symptoms of pharyngitis. Each swab was rolled onto a sheep blood agar plate and then tested with the Strep A Rapid Test Cassette. Plates were streaked for isolation and incubated at 37 °C with 5 to 10 % CO₂ and a bacitracin disk for 18 to 24 hours, with negative cultures incubated for a further 18 to 24 hours. Possible GAS colonies were subcultured and confirmed by latex agglutination grouping. Of the 526 specimens, 404 were culture negative and 122 were culture positive.

Method	Culture positive	Culture negative	Total
Rapid test positive	116	9	125
Rapid test negative	6	395	401
Total	122	404	526

Relative sensitivity	95.1 % (95 % CI: 89.6 to 98.2 %)
Relative specificity	97.8 % (95 % CI: 95.8 to 99 %)
Accuracy	97.1 % (95 % CI: 95.3 to 98.4 %)

Agreement by culture density

Positive culture classification	Rapid test / culture	Agreement
Rare	8/10	80.0 %
1+	18/20	90.0 %
2+	19/20	95.0 %
3+	33/34	97.1 %
4+	38/38	100.0 %

Cross-reactivity

The following organisms were tested at 1.0 × 10⁷ CFU/ml and all gave negative results with the Strep A Rapid Test Cassette. 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 gonorrhoeae
Staphylococcus aureus	Group G Streptococcus	Neisseria subflava
Corynebacterium diphtheriae	Streptococcus sanguis	Haemophilus influenzae
Candida albicans	Staphylococcus epidermidis	Pseudomonas aeruginosa
Enterococcus faecalis

Technical specifications

Product name	AllTest Strep A Rapid Test Cassette (Throat Swab)
Item number (REF)	IST-502
Pack size	20 tests
Intended user	Healthcare professionals
Test principle	Chromatographic lateral flow immunoassay (qualitative)
Target	Lancefield Group A Streptococcus carbohydrate antigen
Specimen type	Throat swab
Sample volume	3 drops (approx. 100 µl) into the sample well
Extraction	4 drops Reagent 1 (approx. 240 µl) plus 4 drops Reagent 2 (approx. 160 µl), 1 minute incubation
Reading time	5 minutes (do not interpret after 10 minutes)
Test temperature	15 to 30 °C
Storage	2 to 30 °C, do not freeze, keep in the sealed pouch until use
Shelf life	24 months from manufacture
After opening the pouch	Use within 1 hour
Specimen stability	Up to 8 hours at room temperature or 72 hours at 2 to 8 °C
Manufacturer	Hangzhou AllTest Biotech Co., Ltd., Hangzhou, China
EU authorised representative	MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany
Marking	CE, in vitro diagnostic medical device
Instructions for use	Revision dated 16 December 2024

Contents

• 20 × test cassette, individually sealed in a foil pouch
• 20 × sterile swab
• 20 × extraction tube
• 20 × dropper tip
• Workstation
• Extraction Reagent 1 (2 M sodium nitrite)
• Extraction Reagent 2 (0.027 M citric acid)
• Positive control (non-viable Strep A, 0.01 % ProClin 300)
• Negative control (non-viable Strep C, 0.01 % ProClin 300)
• Package insert

Also required: a timer.

Limitations

• The test is qualitative only. Neither the quantitative antigen value nor its rate of increase can be determined.
• The test detects Strep A antigen from both viable and non-viable Group A Streptococcus bacteria.
• A negative result should be confirmed by culture. It may occur if the antigen concentration in the throat swab is inadequate or below the detectable level of the test.
• Excess blood or mucus on the swab may interfere with test performance and may yield a false positive result. Avoid touching the tongue, cheeks, teeth and any bleeding areas when collecting the specimen.
• As with all diagnostic tests, results must be interpreted together with the other clinical information available to the physician.

Warnings and precautions

• For professional in vitro diagnostic use only.
• Do not eat, drink or smoke in the area where specimens and kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards and follow standard procedures for specimen disposal.
• Wear protective clothing when assaying specimens: laboratory coats, disposable gloves and eye protection.
• Reagent 2 contains an acidic solution. If it contacts skin or eyes, flush with large volumes of water.
• The positive and negative controls contain ProClin 300 as a preservative.
• Do not interchange reagent bottle caps or external control solution bottle caps.
• Humidity and temperature can adversely affect results.
• Do not use if the pouch is damaged. Do not re-use.
• Discard used tests in accordance with local regulations.