The One Step Dengue NS1 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in serum or plasma to aid in the diagnosis of Dengue viral infection.
SUMMARY
Dengue is transmitted by the bite of an Aedes mosquito infected with any one of the four dengue viruses. It occurs in tropical and sub-tropical areas of the world. Symptoms appear 3 14 days after the infective bite. Dengue fever is a febrile illness that affects infants, young children and adults. Dengue haemorrhagic fever (fever, abdominal pain, vomiting, bleeding) is a potentially lethal complication, affecting mainly children. Early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients. One step Dengue NS1 Ag Test is a simple, visual qualitative test that detects dengue virus NS1 antigen in human serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.
This fully searchable directory currently lists all commercially available immunoassays and molecular tests for COVID-19 of which FIND is aware. Manufacturer performance data (sensitivity and specificity) are included, where known, alongside data from independent evaluations conducted by FIND, where applicable. We are continuing to build this database, and will be adding other tests (which for the moment are still listed here), as well as data from independent evaluations by other entities. This project is part of our work on the ACT-Accelerator Diagnostics Pillar.
The self testing product is transformed from the professional testing product
CLUNGENE COVID 19 Antigen Rapid Test manufactured by Clongene
The BfArM has granted the first special approvals according to 11 paragraph 1
of the German Medical Devices Act ( of antigen tests for self administration by laypersons (self tests) for the detection of SARS CoV 2 Our self testing product can be sold and
used in Germany Overview of CLUNGENE COVID 1
Sample Types :
Including Nasopharyngeal swab, Oropharyngeal swab, Sputum
Controls :
Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results
Product Information
Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.
Authorized Laboratories
Laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.
About Emergency Use Authorization
(EUA)
This test (1) has not been FDA cleared or approved, (2) has been authorized by
FDA under an EUA for use by authorized laboratories, (3) has been authorized
only for the detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.360bbb-3(b)(1), unless the authorization
is terminated or revoked sooner.
The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal
aspirate) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C.
263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infective status. The agent detected may not be
the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The COVID-19 RT-PCR Detection Kit is intended for use by qualified trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization.
PRINCIPLE OF DETECTION
This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will
be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N
gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel.
dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products.
Internal reference is used in the kit for quality control starting from sample collection
Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper
and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high
complexity tests.
This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and, 3. There is no adequate, approved, and available alternative to the emergency use of your
product.
4
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.
Commodity: Covid-19 RT-PCR Detection Kit
Spec.96 tests/kit
Price:FOB SHANGHAI USD3.30/test, USD316.8/kit
$3.60/TEST CIF NY AIRPORT OR OTHER MAJOR AIRPORTS USA OR EUROPE OR S. AMERICA OR MIDDLE EAST
Payment: T/T ADVANCE 50% BALANCE BEFORE DEPARTURE OR Sight Irrevocable TRANSFERABLE LC Delivery: By AIR, 50days after receipt and confirmation of LC
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