Antigen to Respiratory Syncytial Virus RSV -AG rapid test uncut sheet
1. INTEDED USE
The RSV Antigen Rapid Test Device (the Uncut sheet format for manufacturing use) is a rapid immunochromatographic assay intended for the qualitative detection of respiratory syncytial virus (RSV) antigens in human oropharyngeal swab and nasopharyngeal swab samples
This test is intended for in vitro diagnostic professional use and serves as an aid in the early diagnosis of RSV infection in patients with signs and symptoms of respiratory tract infection
The device provides presumptive (preliminary) screening test results. Negative results should be confirmed by alternative molecular diagnostic methods (e.g., RT-PCR or cell culture) when necessary. Positive results do not rule out co-infections with other respiratory pathogens
2. PRODUCT SPECIFICATION
| Model No. | RSV AG Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | oropharyngeal swab and nasopharyngeal swab samples |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 50 sheets /Bag * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove detection reagent and sample to be detected from storage condition and equilibrate them to room temperature (15~30℃). |
| 2 | Open aluminum foil pouch of reagent, take out test device, and place it horizontally on laboratory bench; |
| 3 | Place sample extraction tube upside down vertically (sample extraction tube with sample processed) and add 2 drops vertically into the well of test device. |
| 4 | Test result shall be interpreted within 15~20 minutes, and interpretation result is invalid after 20 minutes. |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
