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COVID-19 Antigen Rapid Testing Kit ( Colloidal Gold )

  • Certificate: FDA; CE; BfArM; CIBG; BAG; BSAG
  • Result in 15 min
  • Easy to use
  • Suitable for all kinds of people
  • Sample type: nasopharyngeal swab; oropharyngeal swab

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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: FDA, CE, BfArM, CIBG

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.

Interpretation of test resultResults available within 15 minutes!

Rapid-Testing-Kit

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

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    Contact Info

    17th floor, Mingsheng Building, Xinluo Street, Jinan

    Phone: +86-531-88982330

    Fax: +86-531-88983691

    Web: www.bioevopeak.com

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