The kit is co-developed by Singapore Agency for Science, Technology and Research (A*STAR) Experimental Drug Development Centre, Bioinformatics Institute, The Diagnostics Development (DxD) Hub and Tan Tock Seng Hospital. The kit has received Singapore Health Science Authority (HSA) approval (MDPA2020-01) and has been deployed in Singapore public and private hospital labs. qPCR testing for specific RNA in nasopharyngeal swab samples. The analytical Limit of Detection (LOD) at 25 copies/reaction. No cross-reactivity with SARS-CoV, Influenza A H1N1, Influenza A H3N2, Influenza B and MERS-CoV. No false negative has been reported to-date
The kit is manufactured in Singapore
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains:
GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request.
To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away.
1. Nasopharyngeal
2. Nasal
3. Saliva
Price and Minumum Quantity
Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces
Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet
Sample: Available. Sample Cost Born By Supplier
Product Model And Origin
Brand: GENEDIAModel: 643G-S (Saliva)
Seller Code: Genedia w covid 19 agHS Code: 3002.15
Standards: Ce
Competitive Advantages
Allow wider testing with fast test time (10 minutes)
All necessary materials provided / no equipment needed
Sensitivity: 93.33%, specificity: 100%
Free sample. no moq. price is negotiable. customized packing.
Other Details
20 tests / kit
24 months from the date of manufacture
2 ~ 30c(35.6 ~ 86f) available for room temperature deliver
In stock. fast delivery.
1 x Instructions for Use Manual
40 x Test Cassettes
1 x Buffer
40 x Dropper
Covd-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and dierential detection of IgG and IgM antibodies to 2019 Novel Corona Virus in human whole blood, serum or plasma.
Specification.jpg
Product: Rapid Diagnostic Test Kit
Item: Corona Virus Test Kit
Specimen: Whole Blood/Serum/Plasma
Format: Strip/Cassette
Port of Loading: Shanghai
OEM and ODM: OEM/ODM Welcome
Shipping: By UPS, FEDEX, DHL, TNT, by air or by sea
Note: Store this product in a cool and dry place, avoid direct sunlight, stay away from places that children can contact, and avoid eye contact. If you have allergies to this product, please stop using and consult a doctor.
COVID-19 Corona Virus Rapid Test Kit11.pngCOVID-19 Corona Virus Rapid Test Kit12.png
Access Bio Care Start Covid-19 Rapid Antigen Test Kit
Product Details:
Number of Reactions(Preps) per Kit : 1
Brand : Access Bio
Test Method : Antigen Test
Result Time (Rapid Kits) : 10 min
Sample Type ; Nasal Swab
Packaging Size : 20 Test Kits/Box
Packaging Type : Box
The CareStart COVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within first five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between
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Angiten-COVID-19 Virus Test Kit (Colloidal Gold)
Quantity of box: 25 persons/box
Brand: Easysweet
NMPA (National Medical Products Administration): Approved
CE: with CE mark
BfArM: listed
Test Method: Antigen Test
Result Time: 10-15 mins
Sample Type: Nasal Swab
Sensitivity: 96.70%
Specificity: 100%
Accuracy: 98.94%
Shelf Life: 24 months
Storage Temperature: 2-30 Degree Celsius
Country of Origin: Made in China
Additional Information:
Production Capacity: 1 million
Delivery Time: 10-15 days
Packaging Details: 25 tests in a pack, 40packs/ carton
Angiten-COVID-19 Virus Test Kit is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. It can be used by professional only.
Price and Minumum Quantity
Price FOB in USD: NegotiableMinimum Order Qty: 10000
Production Capacity: 1000000Packaging: 25 Persons/box
Sample: Available. Sample Cost Born By Buyer
Product Model And Origin
Brand: Easysweet
HS Code: 3822009020
Standards: Ce
Competitive Advantages
Best price with shortest delivery time
Best price with shortest delivery time
Best price with shortest delivery time
Best price with shortest delivery time
Other Details
Angiten-covid-19 virus test kit (colloidal gold)
Angiten-covid-19 virus test kit (colloidal gold)
Angiten-covid-19 virus test kit (colloidal gold)
Angiten-covid-19 virus test kit (colloidal gold)
COVID-19 RT-PCR TEST - NO RNA PURIFICATION NEEDED!
Results in less than 60 minutes, very easy-to-use.
Made in USA, with clinical validations all over the world.
FDA-EUA approved and CE cleared.
- In vitro diagnostics(IVD) Kits
- Designed for the qualitative detection of COVID-19 viral RNA
- Oropharyngeal swab, nasopharyngeal swab, sputum and bronchoalveolar lavage (BAL)
- Store at -25~ -15
Product description:
Detects the novel coronavirus.
COVID-19 using one-step real-time RT-PCR in a single tube.
The target genes for the detection of the virus are Orf1ab and N gene.
The sequence of primers and probes for the amplification were adapted from sources published by China CDC and WHO.
The kit includes primers and probe for the amplification of the human RNase P gene that serves as an internal positive control for the real-time RT-PCR.
Compatible real-time PCR machines: CFX96(Bio-Rad), ABI 7500/7500Fast(Thermo Fisher Scientific), SLAN-96S(Hongshi), Rotor-Gene Q(QIAGEN)
AccuPowe COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 infections, detects SARS-CoV-2 (E gene and RdRp gene) RNA from a suspected infection patient's sample (such as sputum, nasopharyngeal swab, oropharyngeal swab) through Real-Time Polymerase chain reaction(PCR) using ExiStation Universal MDx system.
Our test kit has been approved and endorsed by Singapore's MOH (Ministry of Health) and HSA (Health Science Authority) since last year and we have been constantly supplying to the APAC countries during this period. (Japan, India, Singapore, Malaysia, Indonesia and etc.)
* CE mark was attained in December 2020. *
Our Tepat 1.0 SARS-CoV-2 RT-PCR provides for high-throughput, sensitive and specific detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs*.
It can detect 6 copies of viral RNA per reaction with > 95% confidence. Clinical validation shows 100% sensitivity, with no cross-reaction with non-SARS-CoV-2 species.
Key Highlights
1.5 hours from RNA to results
Multiplex RdRp and M viral genes detection enhances sensitivity and specificity
100% coverage with 100% identity of all SARS-CoV-2 genomes in the world
Detects 6 copies of viral RNA
Whole process control: human RNase P
Cat No : RP10243X. Detection of COVID-19 specific target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient work now on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer.
Product Details:
Number of Reactions(Preps) per Kit : 100
Brand : Seegene
ICMR(Govt) Approved : Yes
Test Method : (SARS-CoV-2) RT-PCR
Test Time : 2 Hours
Cat. No : RP10243X
-Detection of COVID-19 specific target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient work ow on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer
One-step real-time-PCR test for qualitative detection of genetic material of SARS-CoV-2 virus in upper and lower respiratory specimens collected from individuals
suspected of COVID-19 infection.
Targets the RdRp gene and E gene.
Products with high specificity and sensitivity for accurate and reliable results.
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
This kit is intended for qualiativein vitro detection of Orf1ab and N genes of Novel Coronavirus 2019-nCoV which are found in throat swab,sputum and alveolar lavage fuid samples of suspected cases of pneumonia,suspected cases of clustering and other patients who need to carry out diagnosis or differential diagnosis of Novel Coronavirus 2019-nCoV infection.
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