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Covid 19 Antigen Test Clinical Trial

Covid 19 Antigen Test Clinical Trial

Posed on  December 15, 2020, edited by Jason, category  

Clinical Data of Covid 19 Antigen Test

Comparison of Test Results of Kit and Clinical Reference Standard Results
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive45550
Negative4296300
Total9301350

Diagnostic Sensitivity: 45/(50)100%=90%
Diagnostic Specificity: 296/(300)100%=98.67%
The Total Coincidence Rate: (45+296)/(45+5+4+296)*100%=97.43%

LOD of Covid 19 Antigen Test

SARS-COV-2DilutionViral concentration in the Ag deviceR1R2R3
P011000pg+++
P150200pg+++
P2100100pg+++
P3200 50pg+++
P440020pg+++
P580010pg+++
P616005pg+--

Limit of Detection Confirmation:

SARS-COV-2DilutionViral concentration in the Ag deviceRepetitionResults
P580010pgR1+
R2+
R3+
R4+
R5+
R6+
R7+
R8+
R9+
R10+
R11+
R12+
R13+
R14+
R15+
R16+
R17+
R18+
R19+
R20+

Repeatability test of Covid 19 Antigen Test

SARS-COV-2DilutionViral concentration
in the Ag device
RepetitionResults
P320050pgR1+
R2+
R3+
R4+
R5+
R6+
R7+
R8+
R9+
R10+
P580010pgR1+
R2+
R3+
R4+
R5+
R6+
R7+
R8+
R9+
R10+

Cross-reactivity test:

MicroorganismQuantityResults
Influenza A80/8
Influenza B50/5
RSV50/5
SARS31/3
Adenovirus40/4
ParaFlu30/3
M.Pneumonia50/5
Measles virus20/2
Streptococcus pneumoniae10/1
Staphylococcus aureus10/1
EBV30/3
Coxsachie virus CA1620/2
AIV H7N910/1
AIV H5N110/1
Saliwa30/3
Negative serum/plasma200/20

Cross-reactivity test details

The cross-reactivity test results of InfluA positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative808
Total808
InfluA
InfluA
The cross-reactivity test results of InfluB positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative505
Total505
InfluB
InfluB
The cross-reactivity test results of ParaFlu positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative303
Total303
ParaFlu
ParaFlu
The cross-reactivity test results of RSV positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative505
Total505
RSV
RSV
The cross-reactivity test results of SARS positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive101
Negative202
Total303
SARS
SARS
The cross-reactivity test results of Adenovirus positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative404
Total404
Adenovirus
Adenovirus
The cross-reactivity test results of Saliva positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative033
Total033
Saliva
Saliva
The cross-reactivity test results of Serum/Plasma positive samples by SARS-COV-2 antigen test kit
Test kit results (Covid 19 Antigen Test)Clinical Reference Standard ResultsTotal
Positive groupNegative group
Positive000
Negative02020
Total02020
Serum-Plasma
Serum-Plasma

Advantage of Covid 19 Antigen Test

  • Antigen detection window period is earlier than antibody detection.
  • It will be tested immediatley when the body is infected with the SARS COV-2,no need to wait for the body to produce the immune reSponse about less than 7 days.
  • Antigen test is faster than PCR test.
  • Antigen test no other equipment needed, easy to use and operate.The test can be completed in 20 minutes.
Advantage-of-the-Antigen-Test
Advantage-of-the-Antigen-Test

Covid 19 Antigen Test assay Procedure:

Apply 2 full drops of the sample diluent solution(60-70ul) vertically into the sample well of the test cassette. The results are observed after 20minutes and sowed on clinical significance after 20 minutes.

Assay-Procedure
Assay-Procedure

Sample Collection:

Collection method of Nasopharyngeal swab specimen:

The operator holds the swab by the right hand and holds the head of the subject fixedly by the left hand. Putting the sab downing backwards the bottom of the nasal cavity and penetrate slowly and gently. Do not overexert to avoid traumatic hemorrhage. When the tip of the swab touching the posterior parries of the paranasal cavity, letting the swab
remain in the place for a few seconds (about 3seconds) and rotating the swab gently for one cycle and then remove the swab slowly.

Sample-Collection
Sample-Collection

Collection method of Oropharyngeal swab specimen:

The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils n both sides of the person to be collected back and forth with a little force or at least 3 times, and then wipe up and down the posterior pharyngeal wall for the least 3 times.

Sample Treatment:

Add 550ul sample diluent solution into the sampling tube, dip the swab after sample collection into the sample diluent solution, make the solution fully permeate the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the remained liquid as the sample to be tested.

Sample Treatment
Sample Treatment

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