Strep a Antigen Rapid Test Strep a Throat

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HSTR034GA
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The Strep A Antigen Rapid Test is arapid chromatographic immunoassay for the qualitative detection of Group A Streptococcal antigen in human throat swab specimen. This kit is intended for use as an aid in the diagnosis of Strep A infection.
 

SUMMAR
MATERIALS

Materials Provided

Individually packed test devices	Each test contains colored conjugates and reactive reagents precoated at the corresponding regions.
Extraction Reagent 1	1.0 M sodium nitrite
Extraction Reagent 2	0.4 M acetic acid
Positive control	Non-viable Strep A; 0.09% sodium azide
Disposable sampling swabs	For specimen collection
Disposable pipettes	For adding specimens
Extraction tubes	For specimen preparation
Workstation	Workstation
Package insert	For operating instructions

Materials Required but Not provided

Timer

TEST PROCEDURE

Bring tests, specimens, reagents and/or controls to room temperature (1530°C) before use.

1. Prepare swab specimens:

• Place a clean extraction tube in the designated area of the workstation. Add 4 drops of reagent 1 to the extraction tube, then add 4 drops of reagent 2. Mix the solution by gently swirling the extraction tube.
• Immediately immerse the swab into the extraction tube. Use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb.
• Let stand for 1-2 minutes at room temperature, then squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Discard the swab following guidelines for handling infectious agents.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Add 3 drops (approximately 75 µL) of extracted solution with disposable pipettes from the extraction tube to the sample well on the test device.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the observation window.
As the test begins to work, color will migrate across the membrane.

1. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

 

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

 

PERFORMANCE CHARACTERIST

Sensitivity and Specificity
To determine the analytical sensitivity of the test, Group A Streptococcus bacteria organisms were grown by standard culture techniques. The detection limit of the Strep A Antigen Rapid Test was determined to be 1.5×10⁵ organisms per test.
To determine the specificity of the test to Group A Streptococcal bacteria, the following Group A Streptococcal Strains were examined at different levels of organisms per test. Positive results obtained at a level of 1.5×10⁵ organisms/test for all strains indicate that the test is sensitive to Group A Streptococcal bacteria.
Group A Streptococcal Strains:
SS-091 SS-410 SS-492 SS-496
SS-633 SS-634 SS-635 SS-721
SS-754 SS-799 ATCC-19615
Correlation Study
Table: Strep A Antigen Rapid Test vs. Culture 

Method		Culture		Total Results
Strep A Antigen Rapid Test	Results	Positive	Negative
	Positive	131	9	140
	Negative	7	345	352
Total Result		138	354	492

Relative Sensitivity: 94.93% (95%CI: 89.72%~97.71%)  
Relative Specificity: 97.46% (95%CI:95.17%~98.73%) 
Accuracy: 96.75% (95%CI:94.74%~98.03%)
Cross-Reactivity
Cross-reactivity studies with organisms likely to be found in the respiratory tract were also performed using the test. The following organisms were tested at 1×10⁸ organisms/test, and all yielded negative results.

Group B Streptococcus	Group C Streptococcus	Group D Streptococcus
Group F Streptococcus	Group G Streptococcus	Pseudomonas aeruginosa
Streptococcus bovis	Staphylococcus aureus	Proteus vulgaris
Streptococcus faecalis	Staphylococcus epidermidis	Escherichia coli
Streptococcus faecium	Staphylococcus saprophhyticus	Corynebacterium diphtheria
Streptococcus mitis	Neisseria gororrhoeae	Haemophilus parahaemolyticus
Streptococcus mutans	Neisseria lactima	Bordetella pertussis
Streptococcus pneumoniae	Neisseria meningitidis	Moraxella catarrhalis
Streptococcus salivarius	Neisseria sicca	Candida albicans
Streptococcus sanguis	Neisseria subflava

POL Studies
An evaluation of the test was conducted at three physician office laboratory sites, using a panel of coded samples containing negative control, low positive and medium positive specimens. Each specimen level was tested at each site in replicates of five over a period of five days. The study showed >99.9% agreement with the expected results.