COVID-19 신속진단키트
진프로 램프 유전자 검사장비
The NanoCare™ COVID-19 Antigen (Ag) Kit Test is a rapid convenient immune-chromatographic assay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.
The Device is designed to aid in the rapid differential diagnosis of COVID-19 Virus infection
1
Insert a sterile swab into the nostril of the patient, swab over the surface of the posterior nasopharynx. Withdraw the swab from the nasal cavity.
2
Insert the swab into an extraction buffer tube and stir the swab more than 10 times.
3
Remove the swab while squeezing the well of the tube and close the nozzle cap
4
Apply 5 drops of extracted specimen to the specimen well of the test device.
5
Read the results in 10~20 minutes.
Negative
Positive
Invalid
"C" Control Line
"T" Test Line
Total eighty-three of human nasopharyngeal and eight of nasal swab specimens from asymptomatic and symptomatic patients were analyzed.
Nasopharyngeal swab | RT-PCR | |||
---|---|---|---|---|
Positive | Negative | Total | ||
NanoCare™ COVID-19 Antigen (Ag) Kit |
Positive | 31 | - | 31 |
Negative | 2 | 50 | 52 | |
Total | 33 | 50 | 83 | |
Positive Percent Agreement (PPA) | 93.94% (31/33) | |||
Negative Percent Agreement (NPA) | 100% (50/50) |
Nasal swa | RT-PCR | |||
---|---|---|---|---|
Positive | Negative | Total | ||
NanoCare™ COVID-19 Antigen (Ag) Kit |
Positive | 3 | - | 3 |
Negative | - | 5 | 5 | |
Total | 3 | 5 | 8 | |
Positive Percent Agreement (PPA) | 100% (3/3) | |||
Negative Percent Agreement (NPA) | 100% (5/5) |
Cat.No. | SRK-003 |
---|---|
Package Unit | 25 tests/kit |
Kit Component | Test cassette, Reagent tube, Sterilized Nasal Swab, Filter cap, IFU |
Storage Temperature | 2~30 ℃(36-86℉) |
Specimen | Nasopharyngeal / Nasal swab sample |
1
Tilt patient’s head back 70 degrees.
2
Insert swab into nostril. (Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Leave swab in place for several seconds to absorb secretion
3
Slowly remove swab while rotating it. (Swab both nostrils with same swab.)