DE Medical Technology Jiangsu Co.,Ltd 
Test Format: CassetteSpecimen: SwabExpiry date: 24 MonthsFunction: Rapid testStorage: 2-30 centigradeCertificate: CE
IVD Infections disease diagnostic test Group B streptococcal Antigen Strep B test Kit CE Marked
Product Description
| Product Name | Production Information | ||||
| Catalog No. | Specimen Used | Test Format | Kit Size | Sensitivity | |
| Streptococcus(Strep B) | STB-S01 | Nasal Swab | Strip | 20 pcs per box | 97.50% |
| Streptococcus(Strep B) | STB-S02 | Nasal Swab | Cassette | 20 pcs per box | 97.50% |
Intended Use of Strep B Rapid Test Device
The Strep B Rapid Test Device (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group B Streptococcus antigens in human throat swab specimens. This kit is intended for use as an aid in the diagnosis of Strep B infection.
Introduction:
• Beta-hemolytic Group B Streptococcus is a major cause of upper respiratory infection such as tonsillitis, pharyngitis and scarlet fever. Early diagnosis and treatment of Group B Streptococcal pharyngitis has been shown to reduce the severity of symptoms and further complications, such as rheumatic fever and glomerulonephritis.
• Conventional methods used for the detection of the disease depend on the isolation and subsequent identification of the organism. These methods often require 24 - 48 hours to complete. Recent development of immunological techniques which can detect Group B Streptococcal antigen directly from throat swabs allow physicians to diagnose and administer therapy immediately.
Principle of Strep B Rapid Test Device
The Strep B Rapid Test Device (Swab) detects Group B Streptococcusantigens through visual interpretation of color development on the internal strip. Anti-Strep B antibodies are immobilized on the test region of the membrane. During the test, the specimen reacts with polyclonal anti-Strep B antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient Strep B antigen in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicatingthat proper volume of specimen has been added and membrane wicking has occurred.
The presence of this colored band serves as:
1) verification that sufficient volume has been added:
2) verification that proper flow is obtained; and
3) reagent control.
Procedure and Result Reading of Strep B Rapid Test Device
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 alter opening the foil pouch.
2. Add the throat swab to the extraction test tube of Strep B Buffer. Leave the swab in the tube for 1 minute. Then press the swab against the side of the tube and squeeze the bottom of the tube as the swab is withdrawn. Discard the swab.
4.Fit the dropper tip on top of the extraction test tube. Place the test device on a clean and level surface. Add 3 full drops of solution (approx. 100μL) to the specimen well (S) and then start the timer.
5.Wait for the colored line(s) to appear. Read thu result at 5-8 minutes. Do not read the result after 15minutes.
