COVID-19 Antigen Rapid Testing Kit ( Colloidal Gold )

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COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)

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COVID-19 Antigen Rapid Test

This test is suitable for all people, regardless of age. It is a nonintrusive method and perfect for everybody.

  • Children
  • Adults
  • Seniors

Where to find the test?

The test is available and distributed by health professionals, public or private health institutions.

  • Doctors
  • Hospitals
  • Laboratories
  • Clinics
  • Pharmacies
  • Liberal nurses


What are the advantages?

  • No more waiting
  • Result in 15 min
  • Home result in 15 min test by liberal nurse possible

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.

Table 2. 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!
Positive Test

COVID-19 antigen positive (+): A burgundy colored band in the line T and a burgundy color band in the line C must develop in the observation window.

Negative Test

COVID-19 antigen negative (-): a burgundy colored band appear in the line C only and no burgundy colored band develop in the line T, indicating that COVID-19 antigen is not detected in the specimen.

Invalid Test

Invalid: in any case, no burgundy colored band in the line C indicates an invalid assay, suggesting an incorrect test operation or the device is deteriorated and damaged. In this case, the test should be reperformed. If the problem still exists, contact the local supplier or
manufacturer immediately for technological supports.

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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COVID-19 Antigen Rapid Testing Kit ( Colloidal Gold )