In-vitro diagnostics (IVD)
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※Ability to detect the Omicron variant has been confirmed and reported to the MHLW.
Intended use
Detection of SARS-CoV-2 antigen in nasopharyngeal or nasal swabs (to aid in the diagnosis of SARS-CoV-2 infection)
Measuring principle
This assay is based on immunochromatographic technology using monoclonal antibodies against SARS-CoV-2 antigen. The test stick consists of a sample well, a conjugate pad containing colored nanoparticle-labeled anti-SARS-CoV-2 monoclonal antibody (rabbit) (hereinafter, the colored nanoparticle-antibody), a membrane immobilized with anti-SARS-CoV-2 monoclonal antibody (mouse) (hereinafter, a capture antibody) and an anti-rabbit immunoglobulin polyclonal antibody (goat).
Overall View of the Test Stick
Sample dropped on the sample well of the test stick will flow into the conjugate pad due to the capillary phenomenon. The colored nanoparticles-labeled antibody in the conjugate pad will dissolve in the specimen and form the antigen-antibody complex with the SARS-CoV-2 antigen in the sample. The formed antigen-antibody complex continuously move to the membrane and is captured with the capture antibody immobilized on the membrane. The colored nanoparticles of the captured antigen-antibody complex will appear as a red line on the [T1] in the test window. In this kit, appearance of this red line can be visually confirmed to determine the presence of SARS-CoV-2 antigen in the specimen. In addition, the non-complexed antibody conjugated with red nanoparticles will move to the [C] in the test window and be captured with polyclonal antibody against rabbit immunoglobulin immobilized on the membrane. The colored nanoparticles of the captured non-complexed antibody will appear as a red line on the [C] in the test window, indicating that the test is performing successfully.
Measuring Principle
Flow direction
Performance
1. Performance
When tests of sensitivity, accuracy, and reproducibility are performed with a positive control (0.5 ng/test) and a negative control (buffer) in accordance with the procedure in the "Test Procedure", this kit meets the following standards.
A) Sensitivity
"Positive" is confirmed when the positive control is tested as a sample.
B) Accuracy
When the positive control and negative control are tested as samples, "Positive" is confirmed for the positive control and "Negative" is confirmed for the negative control.
C) Reproducibility
When the positive control and negative control are measured three times for each sample, all positive controls are confirmed to be "Positive" and all negative controls are confirmed to be "Negative".
2. Limit of detection
The limit of detection of this kit is 0.1 ng/test.
3. Cross-reactivity
(1) Viruses other than SARS-CoV-2
Influenza Type A virus protein, Flu A protein (NP Antigen)
Influenza Type B protein (TOKIO)
(2) Other coronaviruses
Coronavirus （HCoV-229E） Nucleoprotein
Coronavirus （HCoV-OC43） Nucleoprotein
Coronavirus （HCoV-HKU1） Nucleoprotein
No cross-reactivity was detected in all viruses listed in above (1) and (2).
4. Information on reference standard for calibration
Cellspect Co. Ltd in-house reference standards.
5. Clinical performance data
5.1. Nasopharyngeal swab
(1) Correlation between this kit and RT-PCR test (reference: 3)
a) All samples (cryopreserved samples and on-site samples)
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Positive agreement: 74%
Negative agreement ：98%
Overall agreement ：84%
※ There was one case where this kit was positive and the RT-PCR test was negative. This patient tested positive for RT-PCR the day after sampling.
2) Cryopreserved samples
b%20(%E8%8B%B1%E8%AA%9E)%20.png)
Positive agreement ： 67%
Negative agreement ：100%
Overall agreement ： 75%
c) On-site samples (patients from clinical facilities)
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Positive agreement ：76%
Negative agreement ：98%
Overall agreement ：87%
(2) Positive agreement between samples tested positive by RT-PCR and this kit
a) All samples (cryopreserved samples and on-site samples)
a%20(%E8%8B%B1%E8%AA%9E).png)
b) Cryopreserved samples
b%20(%E8%8B%B1%E8%AA%9E).png)
c) On-site samples (patients from clinical facilities)
c%20(%E8%8B%B1%E8%AA%9E).png)
※ The estimated amount of RNA (copies/5 µL) was adjusted with Ct (cycle threshold) value calculated under the hypothesis that extraction ratio of RNA and other standard molecules in the sample were the same.
※ The copy numbers of virus (copy/test) show the viral load in one RT-PCR test.
※ The positive agreement for samples with more than 1,000 viral copies/test by the RT-PCR test of set N2 was 90% in all samples, 100% in cryopreserved samples and 88% in on-site clinical samples.
5.2. Nasal swab
(1) Correlation between this kit and RT-PCR test
a) All samples (cryopreserved samples and on-site samples)
a%20(%E8%8B%B1%E8%AA%9E).png)
Positive agreement ： 59%
Negative agreement：100%
Overall agreement： 77%
b) Cryopreserved samples
b%20(%E8%8B%B1%E8%AA%9E)%20.png)
Positive agreement ： 69%
Negative agreement：100%
Overall agreement ： 80%
c) On-site samples (patients from clinical facilities)
c%20(%E8%8B%B1%E8%AA%9E)%20.png)
Positive agreement ： 56%
Negative agreement：100％
Overall agreement： 76%
(2) Positive agreement between samples tested positive by RT-PCR and this kit
a) All samples (cryopreserved samples and on-site samples)
a%20(%E8%8B%B1%E8%AA%9E)%20.png)
b) Cryopreserved samples
b%20(%E8%8B%B1%E8%AA%9E)%20%20.png)
c) On-site samples (patients from clinical facilities)
c%20(%E8%8B%B1%E8%AA%9E)%20.png)
※ The estimated amount of RNA (copies/5 µL) was adjusted with Ct (cycle threshold) value calculated under the hypothesis that extraction ratio of RNA and other standard molecules in the sample were the same.
※ The copy numbers of virus (copy/test) show the viral load in one RT-PCR test.
※ The positive agreement for samples with more than 1,000 viral copies/test by the RT-PCR test of set N2 was 82% in all samples, 100% in cryopreserved samples and 78% in on-site clinical samples.
Storage method and expiration date
1. Storage Method: 2 ~ 8 °C
2. Validity Period: 24 months from the date of manufacture
Packaging unit
IQVALF101 Quampas COVID-19 Antigen Test Kit 10 tests
IQVALF011 Quampas COVID-19 Antigen Test Kit 1 test
References
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WHO Website : : “Naming the coronavirus disease (COVID‐19) and the virus that causes it (https://www.who.int/emergencies/diseases/novelcoronavirus- 2019/technical-guidance/naming-thecoronavirus- disease-(covid-2019)-and-the-virus-thatcausesit#:~: text=Official%20names%20have%20been%20announ ced,%2DCoV%2D2)
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Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). WHO Kobe Center published in Japanese
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The Coronavirus Disease 2019 (COVID-19) Pathogen Detection Manual, ver2.9.1. National Institute of Infectious Diseases, Japan
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Guidelines for the operation of assay for the novel coronavirus (SARS-CoV-2), 3rd edition, National Institute of Infectious Diseases, Japan
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Guidelines for testing for novel coronavirus (COVID-19) pathogens, 1st edition, issued on October 2, 2020, MHLW, Japan
Measurement example
An example of use with nasal swab
※ The latest product has been changed from two swabs (one for the nasopharynx and one for the nasal cavity) to one (for both the nasopharynx and nasal cavity).
Swab*1
Package insert
Swab*2
Package insert
10test
Flyer
1test
Flyer
Product purchase / inquiry
To purchase this product, please contact the following e-mail address.
Email: st_support@cellspect.com
TEL: 019-681-2099
Business hours: Weekdays 9: 00 -17: 00 (excluding Saturdays, Sundays, and holidays)
*We cannot offer any support other than the utilization and research of this product. We cannot provide support for the accidental consequences of research activities (such as detection of antibodies suspected of being infected), please consult your local government or agencies.