Audited Supplier
IVD Reagent
CE, ISO
Colloidal Gold Rapid Test
3 Years
Medical Grade ABS Plastic
Bottle + Carton
Early Detection
Screening
Strip+Bottle
Strep a Test Kit
by Eye or Machine
5-10 Seconds
99.7%
3-5 Days
4-30 Degree
Room Temperature
evancare or OEM
Carton
64*50*44 cm
China
3002150090
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.
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as the swab is withdrawn.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)
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 |
