- Certificate: CE; BfArM; CIBG; BAG; BSAG
- Result in 15 min
- Easy to use
- Suitable for all kinds of people
- Sample type: nasopharyngeal swab; oropharyngeal swab
- MOQ: 1000PCS
COVID-19 Antigen Rapid Testing Kit ( Colloidal Gold )
Description
COVID-19 Antigen Rapid Test Advantage
- This test is suitable for all people, regardless of age. It is a nonintrusive method and perfect for everybody.
- Result in 15 min
- Certificate: CE; BfArM; CIBG; BAG; BSAG
CERTIFICATES
CERTIFICATES
Multiple sample types
Equivalence between NPS, OPS sample types was evaluated using inactivated COVID-19 virus spiked into negative samples (one to one, not pooled) to prepare artificial low positive (approximately 312 TCID50/mL inactivated virus) and moderate positive (approximately 1248 TCID50/mL inactivated virus) samples for each sample type. A total of 10 low positive samples, 11 moderate positive paired samples, and 21 negative paired samples were tested with the COVID-19 Antigen Rapid Testing Kit (Colloidal Gold). As shown in Table 2 below, all low positive and moderate positive paired samples were positive in both sample matrices. All negative paired samples were negative in both sample types.
Table 2. Sample type equivalence: nasopharyngeal swab vs oropharyngeal swab
Sample Type | Inactivated added | N | Ag tested positive | Ag tested negative |
NPS | 312 TCID50/ml | 10 | 10/10 (100%) | 0/10 (0%) |
OPS | 312 TCID50/ml | 10 | 10/10 (100%) | 0/10 (0%) |
NPS | 1248 TCID50/ml | 11 | 11/11(100%) | 0/11(0%) |
OPS | 1248 TCID50/ml | 11 | 11/11(100%) | 0/11(0%) |
NPS | Saline | 21 | 0/21(0%) | 21/21(100%) |
OPS | Saline | 21 | 0/21(0%) | 21/21(100%) |
Clinical performance
A total of 69 oropharyngeal swab specimens, including 35 negative and 34 positive samples, were evaluated with both the COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) and a comparator EUA RT-PCR assay (Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCRFluorescence Probing), purchased from the Sansure Bio Tech Inc. The COVID-19 antigen assays were positive in 32/34 confirmed PCR positive samples (94.12% positive agreement). The COVID-19 antigen was not detected in any of the confirmed PCR negative specimens (100% negative agreement). Results are summarized in the table below.
Sample type equivalence: nasopharyngeal swab vs oropharyngeal swab
COVID-19 antigen tested | Nucleic Acid Tested | Total | |
RNA positive | RNA negative | ||
Ag positive | 32 | 0 | 32 |
Ag negative | 2 | 35 | 37 |
Total | 34 | 35 | 69 |
Positive agreement: 32/34 = 94.12% [80.32% ~ 99.28%] | |||
Negative agreement: 35/35 = 100.00% [90.00% ~ 100.00%] |
Easy to use
1. Specimen: nasopharyngeal swab (NPS), oropharyngeal swab (OPS) and saliva specimens.
2. NPS and OPS collection:
- a. Add whole extraction buffer (~250 μl) into a tube for use.
- b. The disposable sterile cotton swab is inserted into the nasopharyngeal/oropharyngeal cavity and rotated rapidly and gently 5 times in bilateral pharyngeal tonsils and posterior pharyngeal wall to collect mucosal epidermis to avoid contact with oral and lingual mucosa.
- c. Put a specimen swab into a tube with the extraction buffer, fully stir 10 times, squeeze the swab head along the inner wall of the tube.
- d. Take out and discard the swab.
3. Saliva collection:
- a. Keep mouth clean for 3 minutes and stir the upper wall of the mouth with tongue.
- b. Open the device pouch to collect the saliva.
- c. Insert a spare cotton swab and sink the cotton ball into the saliva until the cotton ball is completely wet.
- d. Put the swab into a tube with the extraction buffer, fully stir 10 times, squeeze the swab head along the inner wall of the tube.
- e. Take out and discard the swab.
Specimen Testing
• Take a test device to room temperature and allow it sitting for a few minutes.
• Tear off the pouch at the notch.
• Take out the test device and microdropper.
• Place the test device horizontally on a clean workbench.
• Transfer 2 drops (about 60 μL) of specimen into the specimen (S) hole of the test device.
• Wait 15 minutes to record a test result. Do not record any result after 30 minutes.
• Discard the test device and disinfect the table.
• Report the result.
Packing
Catalogue Number | MU00301 | MU00325 | |
Kit Size ( test ) | 1 | 25 | |
Component | Sample lysis buffer | 1 | 25 |
Sample bottle with lid | 1 | 25 | |
cotton swab | 1 | 25 | |
test cartridge | 1 | 25 | |
Microdropper | 1 | 25 | |
IFU Leaflet | 1 | 1 |
Get Social