Prima Home Strep A test 1 pcs

Prima Home Strep A test 1 pcs
The Prima Home Streptococcus A test is used to detect ß-hemolytic group A streptococci in throat swab samples. ß-hemolytic group A streptococci are gram-positive bacteria, that cause a number of diseases, like pharyngitis, skin infections, acute glomerulonephritis, sepsis and rheumatic heart disease. Test enables detection of A-streptococcus in throat infection. It will help to determine whether the sore throat is caused by group A streptococcus or other germs. The package contains everything needed to perform one test. The result can be read within 5 minutes.
Key features of the Prima Home Strep A test 1 pc
- Test for the detection of ß-haemolytic group A streptococci in throat swab samples
- Help determine if the sore throat is caused by group A streptococcus or other germs
- The package contains everything needed to perform one test
- Identifies group A ß-haemolytic streptococci if their concentration in the extracted sample is equal to or greater than 104 CFU/ml
- The Prima Home Strep A test offers a specificity of 99% and a sensitivity of 91.89%
- The result can be read within 5 minutes
The Prima Home Strep A test offers a specificity of 99% and a sensitivity of 91.89%
The Prima Home Strep A test can be used when symptoms include, which include pain on swallowing, sore throat, red and swollen tonsils, possibly with a white coating or pus, small red spots on the back of the palate, swollen lymph nodes, fever, headache, nausea or vomiting. Identifies group A ß-haemolytic streptococci when the concentration in the extracted sample is equal to or greater than 104 CFU/ml. The Prima Home Strep A test offers a specificity of 99% and a sensitivity of 91.89%. Detects the presence of specific Strep A antigens thanks to the gold-conjugated antibodies contained in the test strip. In the case of throat infections, it may be ß-haemolytic group A streptococci. Proper antibiotic treatment requires prior identification of the bacterium.
The test specifically identifies group A ß-haemolytic streptococci if their concentration in the extracted sample is equal to or greater than 104 CFU/ml (cut-off value). In some cases, samples with concentrations below this value (up to 5 × 103 CFU/ml) may give a positive result. The test is very accurate. The evaluation reports indicate an analytical specificity of 99.00 % (CI 95 %: 97.63-100%) and sensitivity 91.89% (CI 95%: 78.70-97.20%) with an overall concordance rate of 97.90% (CI 95%: 96,08-99,72 %).
Follow the instructions in the instructions included in the package.
1 hermetically sealed aluminium bag contains: 1 tape STREPTOKOK A TEST (STREP A TEST), 1 bag with drying agent, 1 sterile swab, 1 sterile wooden spatula to compress the tongue, 1 empty plastic tube with dropper for sampling, 1 dropper bottle with STREPTOKOK A TEST (STREP A TEST) solution - R1 (Blue cap), 1 dropper bottle with STREP A TEST (STREP A TEST) solution - R2 (Green cap), 1 instructions for use
Hazard H 302: Harmful if ingested. Attention P264: Wash your hands thoroughly after use. P270: Do not eat, drink or smoke while using. Warning: Keep the test out of the reach of children. Read the instructions for use and information on safe use carefully. Test registered with SÚKL/IVDst 01188965
Specifications
Medical device
Product characteristics
Usage
Use
Basic information
Number of pieces in package
| Code: | SPTprho007 |
| Warranty: | 24 months |
| Links: | Producer's Website: |
| Manufacturer information |
IMMOMEDICAL CZ s.r.o., Novodvorska 994/138, 142 21 Praha 4 Branik, CZ, 239042466, [email protected], www.immomedical.cz
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