OEM One Step Sterility Test Strip Accurate Strep a Rapid Test

Product Description

 

Product Description

EVANCARE Strep A Test Diagnostic Kits Strep A Rapid Test Device Swab /Infectious Disease Diagnostic Kit                                 

 

For professional and in vitro diagnostic use only.
 

[INTENDED USE]

 

The Strep A Rapid Test Device (Swab) is a rapid chromatographic immunoassay for the qualitative

detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A

Streptococcal infection.
 

[PRINCIPLE]

The Strep A Rapid Test Device (Swab) is 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 color line in the test

line region. The presence of this color 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.

 

 

 

 

 

 

 

 

Detailed Photos

 

Allow the test device, reagents, throat swab specimen, and/or controls to reach room

temperature (15-30°C) prior to testing.

1. Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will

be obtained if the test is performed immediately after opening the foil pouch.

2. Hold the Reagent A bottle vertically and add 4 full drops (approximately 260μl) of Reagent A to

an extraction tube. Reagent A is red in color. Hold the Reagent B bottle vertically and add 4 full

drops (approximately 260μl) to the tube. Reagent B is colorless. Mix the solution by gently

swirling the extraction tube. The addition of Reagent B to Reagent A changes the color of the

solution from red to yellow.

3. Immediately add the throat swab to the extraction tube of yellow solution. Agitate the swab 10

times in the tube. Leave the swab in the tube for 1 minute. Then squeeze the swab in the tube wall

as the swab is withdrawn. Discard the swab.

4. Fit the dropper tip on top of the extraction tube. Place the test device on a clean and level surface.

Add 3 full drops of solution (approximately 180μl) to the specimen well (S) and then start the

timer.

5. Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not read the result after 10

minutes.

 

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.

 

Item No.	EVANCARE Strep A Test Diagnostic Kits Strep A Rapid Test Device Swab /Infectious Disease Diagnostic Kit
Contents	Each bag:1 test cassette and 1 desiccant(cassette)                  25 cassettes+25 swab+25 tube +1 work station+ buffer A+Buffer B /box antigen test      We can put instruction as your requirement
Format / Size	Cassette:2.5mm 3.0mm 4.0mm
Methodology	Sandwich Colloidal Gold
Assay Type	Qualitative Detection
Specimen	Antigen  (swab),
Indicator	Strep A Test Cassette
Storage Temperature	4-30 degree centigrade

Expiry date	3  years
Certificate	CE,ISO,FREE SALE,FDA...
Detection Limits	Home or Professional Use
Accuracy	> 99.99%
Reaction Time	3-5 min
Delivery	5-7 days
OEM Service	Available
Shipping Method	by air  or sea or international express

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