This kit is only used for the in vitro qualitative detection of 2019-nCoV antigen from
human nasopharyngeal swab, nasal swab or oropharyngeal swab specimens.
This kit is suitable for the auxiliary diagnosis of COVID-19, the results are for clinical
reference only and cannot be used as the sole basis for diagnosis and exclusion
decision. The clinical diagnosis and treatment of patients should be considered in
combination with their symptoms/signs, medical history, other laboratory tests and
treatment responses.
Positive test result needs to be further confirmed, negative result does not preclude
2019-nCoV infection.
This kit is intended for use by qualified and trained clinical laboratory personnel
specifically instructed and trained in the techniques of in vitro diagnostic procedures.
TEST PRINCIPLE
The kit is immunochromatographic and uses double-antibody sandwich method to
detect 2019-nCoV N protein antigen. During detection, the treated specimens are
loaded into the sample wells of the test card. When the concentration of 2019-nCoV
antigen in specimen is higher than the minimum detection limit, the viral antigen will
form complexes with labeled antibodies first. Under chromatography, the complexes
move forward along the nitrocellulose membrane till captured by pre-coated
monoclonal antibody of 2019-nCoV in detection zone on nitrocellulose film (T) to
form a pink/purple reaction line on the detection zone, at this point the result is
positive; conversely, if there is no viral antigen or the concentration of antigen in
specimen is below the minimum detection limit, no pink/purple reaction line appears
in the detection zone, at this point the result is negative. Regardless of whether the
sample contains viral antigens or not, a pink/purple reaction line will appear in the
quality control zone (C), the pink/purple reaction line that appears in the quality
control zone (C) is the criterion for determining if the chromatography process is
normal.
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Product Description
SARS-COV2 Antigen Rapid Test Card contains a gold-labeled novel coronavirus N protein monoclonal antibody pre-coated on the bonding pad and a paired novel coronavirus N protein monoclonal antibodies �xed in the test line (T) and corresponding antibodies in the quality control line (C).
SARS-COV2 Antigen Rapid Test Kit can detect the virus from the rst phase of infection (2-3 days before potential symptom onset) to the last phase of infection (7-10 days after potential symptom onset).
Used to test COVID-19 antigen
Card-like format detects the nucleocapsid (N) protein of the virus.
Gold-labelled SARS-CoV-2 N protein monoclonal antibodies immobilized on the test area, with corresponding antibodies in the quality control area.
Swabbed specimens from the nasopharynx or oropharyngeal, result in 15 minutes
Product Features
Non-invasive
Simple to use
Convenient, no devices required
Rapid, get a result in 15 minutes
Stable, with high accuracy
Inexpensive, cost-efficiency
Related News
On 26th Jan 2021, report from PEI of an official test that The Federal Institute for Drugs and Medical Devices (Bundesinstitut fr Arzneimittel und Medizinprodukte, BfArM) authorized to perform, declared that Lepu Medical SARS-CoV-2 Antigen Rapid Test Kit has fulfilled all the minimum criteria for antigen tests conducted by PEI in consultation with the Robert Koch-Institut (RKI).
In March 2021, German BfArM approved Lepu Medical SARS-CoV-2 antigen rapid test kit for home use. The test kit makes the coronavirus detection procedures rapid and easy.
Coronavirus IgG/IgM Dual Detection Kit:
*****Just approved for marketing by Taiwan Food and Drug Administration, Ministry of Health and Welfare ,
It is the fastest (around 2-3 minutes) and the most accurate up to 97.3% comparing with global test kit.
Made in Taiwan
It can save the life because some hospitals require a confirmed test report ,then just will allow you to be hospitalized.
Patients can get the fastest treatment and master the golden treatment time!!!
This kit is used for the qualitative detection of specific antigen against novel coronavirus (SARS-CoV-2) in human specimens (Nasal swabs, oropharyngeal swabs, lower respiratory tract samples).
Principle
This kit adopts colloidal gold-based flow-through, lateral-flow immunoassay and capture method to detect specific antigen against coronavirus in human specimens(Nasal swabs, oropharyngeal swabs.
LEPU tests for German customers with instructions in German, we are authorized distributors in Germany. You can buy Cash and cary ( Inspection and pay) from us) There are 700,000 tests in stock in Individual packaging , with a quality control tape on each one, which is not a fake of which there are many on the market now.
Prices from 5000-10 000 tests - 4.8 euros
from 10 000 - 50 000 - 4,65 euro
from 50 000- 100 000 - 4,50 euro
from 100 000-4, 35 euro .
This is the price already for the product that is in place
When ordering for production at the factory : Lapu under the order of 100,000 tests or more
CIF price under the bank-or prepayment of 30% 70 on arrival - 3,4
250 000 - 3,15
300 000 - 3,05
From 1 million - 2,95
CE Approved MAU is a rapid visual immune-assay for the qualitative, presumptive detection of albumin in urine for self-testing. The test used as a supplementary method in the diagnosis of diabetic nephropathy and other renal damage. MAU occurs when the kidney leaks small amounts of albumin into the urine.
The first indicator of a renal dysfunction, especially for diabetic patients
Independent risk indicator to evaluate the profession of chronic kidney disease (CKD).
Bacterial Vaginosis Quick Test Kit is designed as a simple, rapid, cost effective method for in vitro testing. It is qualitative test for the determination of neuraminidase (SNa) in female vaginal fluid, which is auxiliary diagnosis of bacterial vaginosis.
Application
Used to assist the diagnostic of bacterial vaginosis, evaluate the micro ecological balance in genital tract, and to prevent recurrences of vaginosis.
Advantage
High sensitivity, strong specificity
Easy operation, convenient and effective
No need of special instrument, no need of professional training
CE Approved The Follicle Stimulating Hormone (FSH) Test Kit is a rapid qualitative test for detect FSH in urine. This help to check the function of the pituitary gland and check if hormone levels are normal. The test can be used to see if a woman has started the menopause. The test may also be used (along with other tests) for detecting possible causes of both male and female infertility.
Self-detection of ovarian function
Guide to prevention of premature ovarian
Diagnosis of menopause
CE Approved The Luteinizing Hormone(LH) Ovulation Test Kit is a rapid, visual, and one-step test for the qualitative determination of LH surge in human urine specimens, to help predict ovulation time, signaling that ovulation is likely to occur in the next 24-48 hours, so as to guide reproductive women to choose the optimal conception time or safe period contraception.
Specification
This test kit is divided into three types. The specific specifications are as follows:
Strip: 1 test/box; 5 tests/box; 25 tests/box; 25T/Canister; 50 tests/box
Cassata: 1 test/box; 5 tests/box; 25 tests/box; 50 tests/box
Midstream: 1 test/box; 20 tests/box
Advantage:
Simple to use, no need for additional equipment, qualitative result in 2-5 minutes
10-25mlU/mL sensitivity
Over 99% accuracy
OEM service
CE Approved The human Chorionic Gonadotropin (HCG) Pregnancy Test Kit is a rapid, one-strip lateral flow immunoassay for the qualitative determination of HCG in human urine specimens, to aid in the early detection of pregnancy.
Advantage:
Simple to use, no need for additional equipment, qualitative result in 2-5 minutes
10-25mlU/mL sensitivity
Over 99% accuracy
OEM service
Product Description
GeneTransport Medium Set - SG Medical
Price of product ( USD price or FOB price) :
USD2.4/set
FOB Korea
Product origin :
REPURBLIC OF KOREA
HS code
3821.00.0000
Key Specifications/Special Features :
* For use in collecting, transporting and preserving salvia, oropharyngeal and nasopharynegeal specimens for the testing of respiratory pathogen
* Increased testing accuracy:
^ Safe transport of samples by inactivation microbes and viruses
^ Visual checking of contamination using the indicator
^ 2 brushes for nasal and salvia samples
* Stability of human body
^ Reduction of exposure to hazadous substances by using harmless water-based adhesive to attach brushess
* Increased convenience
^ Automatic removal of brushes when the stopper is opened after transpoer
* Storage method: unopened. At 18~25 deg.C for 12months after manufacturing
Minimum Order Size and Packaging details :
MOQ: 5000 sets
Price of product ( USD price or FOB price) :
USD9.0/test
FOB Korea
Product origin :
Republic Of Korea
HS code
3822.00.1020
Key Specifications/Special Features :
* Target gene: Betacoronavirus (SARS, SARS-related), 2019-nCov
* Specimen: Sptim, Nasopharyngeal aspirate, Throat & nasopharyngeal swab, Baronchoalveolar lavage
* Analytical sensitivity: all target 100 copies/rxn
* Cut-offs: All analytes < 40 sycles
* 100%(set.cov) of coverage for genes of RdRP, E and N
* RT-PCR condition: 1H 30M (4 steps)
* Work flow: Auto exreaction and/or PCR set up --> Amplification & Detection (1.5H) --> Result interpretaion (Whole process TAT <4Hr)
Certificates
CE, EAU - FDA, Korea FDA
Minimum Order Size and Packaging details :
MOQ: 1000 kits
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