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
COVID-19 IgG/IgM Rapid Antibody Test Kit with EUA FDA approval. Available immediately!
(Whole Blood/Serum/Plasma) is a solid phase immuno chromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
- Fast results as soon as 2-10 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- Little specimens, only 5L of serum/plasma or 10L of whole blood specimens
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
- Sensitivity: IgG 97.2%; IgM 87.9%
- Specificity: IgG 100%; IgM 100%
- Specimen: Whole Blood, Serum, Plasma
- Shelf Life: 24 months from the date of manufacture
Number of Reactions(Preps)/Kit 30T
Brand Abbott
Usage/Application Hospital
Result Time (Rapid Kits) 15 mins
Cat. No 02FK10I30
Bioline HCVHEPATITIS C VIRUS TEST
When speed matters, choosing a highly sensitive rapid HCV test with a safe fingerstick procedure can make a difference.
In the global effort to eliminating viral hepatitis, fast detection in a wide range of settings and linkage to care are critical for achieving successful outcomes
Bioline HCV test is a immunochromatographic rapid test for the qualitative detection of antibodies specific to HCV in human serum, plasma or whole blood.
Specification:
Specimen :
- Serum, Plasma, Whole Blood (10 �¼l) for 02FK10, 02FK10CE, 02FK16, 02FK16CE, 02FK17, 02FK17CE, 02FK11
- Serum or Plasma (10 l) for 02FK12
Sensitivity :
- 99.3% (95% CI: 97.9 - 99.8%) for 02FK10CE, 02FK16CE, 02FK17CE
- 99.3% (95% CI: 96.1 - 99.9%) for 02FK10, 02FK16, 02FK17
- 100 % (97.6 - 100 %) for 02FK11, 02FK12
Specificity :
- 100% (95% CI: 99.7 - 100 %) for 02FK10CE, 02FK16CE, 02FK17CE
- 98.1% (95% CI: 94.5 - 99.4%) for 02FK10, 02FK16, 02FK17
- 99.4 % (98.7 - 99.7 %) for 02FK11, 02FK12
Shelf life: 24 months at 1-30C
Qualitative immunochromatographic assay
Recombinant HCV core, NS3, NS4, NS5 Ag used as capture materials
Unique sealing tube test strip series is the main breaking through the invention of amazing biotech, Which can diagnose all the three stages of the covid19 including Virus, antigen, and antibodies.
Here we compare the screening method of different types of testing carried out for Covid-19 including nucleic acid, antigen-based, and antibody-based testing. The comparison is done on the basis of sampling specimen, earliest stage detection, time taken by each, Clinical significance of positive results, Specificity, Sensitivity, and technical difficulty. For nucleic acid testing, the specimen used must be nasopharyngeal swabs, sputum, buffer. For antigen specimen, the specimen must be nasopharyngeal swabs, sputum, buffer, urine. And for antibody-based testing, the specimen used must be plasma and serum. Similarly, the earliest stage detection for nucleic acid testing is after infection, and before symptoms arise. Antigen-based testing is also after infection before symptoms arise and antibody-based testing is One week after symptoms arise. The time taken to carry out the nucleic acid test is 60-180 mins, for antigen test is 10 to 15 minutes and for antibody test is 15 to 180 minutes.
Product Detail
PRINCIPLE
Amazing COVID-19 Antigen Lockseal Tube Test Strip is based on sandwich lateral flow immunochromatographic assay highly sensitively detecting COVID-19 nucleocapsid protein in human nasopharyngeal, nasal secretion, saliva or/and serum specimens, having an invisible T (test) zone and C (control) zone. When the sample is applied into the test tube, the liquid will laterally flow on the surface of the test strip. If there is enough COVID-19 antigen in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of COVID-19 antigen in the sample.
Specification
V.A: 20/24 kits X 1 pouch/box, 20/24 kits X 5/4 pouches/box
V.B: 20/24 kits X 1 pouch/box, 20/24 kits X 5/4 pouches/box
V.C: Duplex kits X 10/12 pouches/box, Duplex kits X 48/50 pouches/box
V.D: Duplex kits/pouch/box
Number of Reactions(Preps)/Kit : 96 Wells
Brand : CTK BioTech
Sample Material : Plasma/Serum
Storage : 2-8 C
Cat. No : E0105
INTENDED USE:
The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of anti-hepatitis E virus (HEV) IgM in human serum or plasma. It is intended for professional use only and to be used as an aid in the diagnosis of infection with HEV.
TEST PRINCIPLE:
The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the IgM capture technique for the detection of antiHEV IgM in human serum or plasma. The RecombiLISA HEV IgM ELISA is composed of two key components: 1) Solid microwells pre-coated with polyclonal anti-human IgM antibody 2) Liquid conjugate composed of HEV antigen conjugated with horseradish peroxidase (HRP-HEV Conjugate) During the assay, the test specimen is first incubated in the coated microwells. AntiHEV IgM, if present in the specimen, binds to the antibody coated on the microwell surface. Any unbound specimen is then removed by a wash step. During a second incubation with the HRP-HEV Conjugate, the anti-HEV IgM antibody is absorbed on the microwell surface which binds to the HRP-HEV Conjugate, forming a conjugate complex. Unbound conjugate is then removed by washing. After addition of the TMB substrate, the presence of conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. The reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm.
Clinical Performance:
A total of 400 specimens from susceptible subjects were tested by the RecombiLISA HEV IgM ELISA and by a Chinese State Drug Administration (SFDA) licensed reference EIA.
Product Details:
Number of Reactions(Preps)/Kit ; 96 Wells
Brand : InBios
Format : Immunocapture
Specimen : Serum
Cat No : ZKM2-1
The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection and may be detectable near day four post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
1st Commercial serology kit to receive FDA Marketing Authorization
CE Marked
Differentiates Zika IgM positive patients from those infected with other flaviviruses such as West Nile or Dengue
Sensitivity: >90%
Specificity: >96%
Results in 4 hours
Tests up to 28 unknown specimens.
Number of Reactions(Preps)/Kit : 96 Wells
Brand : CTK BioTech
Sample ; Serum
Storage : 2-8 C
Cat No : E1030
The RecombiLISA TSH ELISA is a solid phase enzyme linked immunosorbent assay for the quantitative determination of the levels of Thyroid Stimulating Hormone (TSH) in human serum.
The RecombiLISA TSH ELISA is intended for professional use as an aid in the diagnosis of thyroid dysfunction. TSH values should not be the only factor in the determination of thyroid status, and all other available clinical and epidemiological information should be considered for an accurate diagnosis.
Recommended for use:
Any person presenting with signs or symptoms of hypo or hyperthyroidism
Any person presenting with an enlarged thyroid gland (goiter)
Pregnant women for first trimester screening
Any person requiring regular monitoring of treatment
Normally, thyroid function is first assessed by detection of TSH levels in the blood.
The monoclonal anti-TSH antibody coated on the surface of the microwells specifically recognizes the junction between the �± and �² subunits. The HRP-conjugated monoclonal anti-TSH antibody detects the �² subunit only.
Combining the measurement of TSH with the thyroid hormones (T3/T4) can provide more information for the determination of thyroid status.
Product Features :
Sensitivity: Detects TSH levels as low as 0.035 �µIU/mL
Specificity: No cross reactivity detected with related hormones: FSH, LH and hCG
Linearity: 1:128 dilution on 36 IU/mL sample
Precision: intra assay precision: CV 7.5%; inter assay precision: CV 8.0 %
Accuracy: R2= 0.986 against Roche TSH Chemiluminescence Immunoassay
Hook effect: No hook effect up to 8000 IU/mL
Interference: not affected by Hemoglobin 500mg/dL, Diltiazem 15uM, Bilirubin 20 mg/dL, Erythromycin 81.6uM, Triglycerides 3g/dL, Verapamil 4.4uM, HAMA 52.5ng/mL, T3 100ng/mL, RF 215IU/mL, T4 100ug/dL, Acetaminophen 1324uM
Calibration: Human TSH WHO 3rd International Standards (81/565 NIBSC)
Calibrators: 0, 0.5, 2.0, 5.0, 10, 20, 40 �µIU/mL in biological matrix
Shelf life: 18 months
Assay time: 80 minutes.
Product Specifications:
Anti-TSH Ab coated microwells
TSH standard S1
TSH standard S2
TSH standard S3
TSH standard S4
TSH standard S5
TSH standard S6
TSH standard S7
HRP-anti-TSH conjugates
TMB substrate
Wash buffer (30X concentrate)
Stop solution
ELISA working sheet
Product insert
Product Details:
Number of Reactions(Preps)/Kit : 96 Wells
Brand : CTK BioTech
Sample : serum or plasma
Storage : 2-8 C
Cat No : E0330
The RecombiLISA Leptospira IgM ELISA Kit is an indirect, solid phase enzyme-linked immunosorbent assay. The two main kit components are:
1) A 96 breakable well plate with the solid microwells pre-coated with L. interrogans antigen.
2) Liquid conjugates composed of monoclonal anti-human IgM reagent conjugated with horseradish peroxidase (HRP-anti-human IgM conjugates).
This test is intended to be used for the qualitative detection of IgM anti-Leptospira interrogans (L. interrogans) in human serum or plasma. It is intended to be used by professionals as an aid in the diagnosis of acute infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.
Recommended for use:
Any person presenting with clinical signs or symptoms consistent with acute infection with interrogansincluding: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash
After exposure to a known contaminated source
Product Features :
Sensitivity: 86.7%
Specificity: 96.8%
Cross Reactivity: No false positive results were observed on specimens from Dengue, Malaria, Typhi, ANA, HAMA, RF, HIV, HBsAg, HCV, Syphilis, pylori
Interference: No interference was seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 1.3 %;Heparin: 3,000 U/L; Creatinine: 5 mmol/L; Bilirubin: 10 mg/dL; EDTA: 3.4 �µmol/L
Shelf life: 12 months
Open vial stability: 8 weeks at 2-8 C, or until the expiration date
Kit Components :
Microwells coated with recombinant L. interrogans antigens
Lepto IgM positive control
Lepto IgM negative control
Sample diluent
HRP anti-human IgM conjugate
Wash buffer (30 x concentrate)
TMB substrate A
TMB substrate B
Stop solution
ELISA Working Sheet
Product insert
COVID-19 Ag/Ab Sealing Tube Twin Test Strip (Colloidal Gold)
INTENDED USE:
Amazing COVID-19 Ag/Ab Sealing Tube Twin Test Strip is a lateral flow immuno- chromatographic assay for the simultaneous rapid in vitro differential detection of COVID-19 nucleocapsid protein antigen and COVID-19 antibody (IgG/IgM). The kit has two strips. One strip is for the qualitative detection of COVID-19 nucleocapsid protein antigen in human nasopharyngeal, nasal secretion, saliva or/and serum specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Another strip is for the qualitative detection of COVID-19 antibody(IgG/IgM) in human serum, plasma (sodium citrate, sodium heparin, dipotassium EDTA), and whole blood (sodium citrate, sodium heparin, dipotassium EDTA or fingerstick whole blood) to aid identifying individuals with an adaptive immune response to COVID-19, indicating recent or prior infection and patients with suspected COVID-19 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the Amazing COVID-19 Ag/Ab(IgG/IgM) Sealing Tube Twin Test Strip should not be used as the sole basis for diagnosis. The kit is assistance for diagnostic and epidemiological investigation. These two strips are in the sealing tube to avoid potential biosecurity substances such as coronavirus from clinical samples, which will much help to avoid pathogen contamination and spreading to the operator and its environment. The kit is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings.
COVID-19 Ag/Ab(IgG/IgM) Sealing Tube Test Strip (Colloidal Gold):-
INTENDED USE:
Amazing COVID-19 Ag/Ab(IgG/IgM) and Influenza Ag(A/B) Sealing Tube Twin Test Strip is a lateral flow immunochromatographic assay for the simultaneous rapid in vitro differential detection of COVID-19 and Influenza virus.
The kit has two strips. One is for the qualitative detection of COVID-19 nucleocapsid protein antigen and Influenza virus type A in human nasopharyngeal, nasal secretion, saliva or/and serum directly collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Another is for the qualitative detection of COVID-19 antibody(IgG/IgM) in human serum, plasma (sodium citrate, sodium heparin, dipotassium EDTA) and whole blood (sodium citrate, sodium heparin, dipotassium EDTA or fingerstick whole blood) and Influenza virus type B in human nasopharyngeal, nasal secretion, saliva or/and serum specimens to aid identifying individuals with an adaptive immune response to COVID-19, indicating recent or prior infection and patients with suspected COVID-19 infection in conjunction with clinical presentation and the results of other laboratory tests.
Results from the Amazing COVID-19 Ag/Ab(IgG/IgM) and Influenza Ag(A/B) Sealing Tube Twin Test Strip should not be used as the sole basis for diagnosis. The kit is assistance for diagnostic and epidemiological investigation. These two strips are in the sealing tube to avoid potential biosecurity substances such as coronavirus from clinical samples, which will much help to avoid pathogen contamination and spreading to the operator and its environment. The kit is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings.
"Factview H. pylori Ab" likely refers to a diagnostic test for detecting antibodies against Helicobacter pylori in biological samples. Helicobacter pylori is a bacterium that colonizes the stomach lining and is associated with various gastrointestinal conditions, including gastritis, peptic ulcers, and even stomach cancer.
The "H. pylori Ab" test is designed to identify the presence of antibodies produced by the body in response to H. pylori infection. These antibodies can be detected in serum (blood) samples and serve as markers of past or present H. pylori infection.
The test usually involves collecting a blood sample from the patient and then processing it to detect H. pylori antibodies using immunological methods such as enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay (CLIA). These methods rely on the specific binding of antibodies to H. pylori antigens present in the test kit, leading to a visible or measurable signal indicating the presence of antibodies.
Detection of H. pylori antibodies in clinical samples can help confirm H. pylori infection and guide appropriate treatment strategies. However, it's important to note that the presence of antibodies may indicate either current or past infection, as antibodies can persist in the bloodstream for some time after the infection has been cleared. Therefore, additional tests or clinical evaluation may be necessary to determine the timing and severity of the infection.
Number of Reactions(Preps)/Kit : 25T
Brand : Abbott
Usage/Application : Hospital
Results : 15 min
Sample type : Blood
Cat. No : 08FK50
Bioline TB Ag MPT64TEST TO DISCRIMINATE BETWEEN M. TUBERCULOSIS COMPLEX AND MOTT(NTM)
Bioline TB Ag MPT64 is a immunochromatographic identification test for the M. Tuberculosis complex. Biochemical, immunological and molecular biological characterization of Mycobacterium tuberculosis has led to the identification of several antigens which may be useful in the development of improved diagnostic methods in order to discriminate between the M. tuberculosis complex and mycobacteria other than M. tuberculosis (MOTT bacilli). M. tuberculosis has been known to secrete more than 33 different proteins. One of the predominant proteins, MPT64 was found in the culture fluid of only strains of the M. tuberculosis complex.
Performance
Sensitivity: 98.6 %, Specificity: 100 % (vs. Isolated culture method)
Simple, rapid assay using mouse monoclonal anti-MPT64
Rapid discrimination between the M. tuberculosis complex and other mycobacterium
Identification of the M. tuberculosis complex in combination with culture systems based on liquid media
Specimen : Solid cultures (colony, condensation fluid) or liquid cultures
Time to result : 15 minutes
1-30 C for 18 months
VETLabs Toxoplasma IgM/IgG test is a sandwich lateral flow immunochromatographic assay, developed and manufactured by Bioguard Corporation, for the rapid and qualitative detection of Toxoplasma IgM/IgG in cat's blood. The test device has a testing window, coated by an invisible T (test) zone and C (control) zone. When a sample is applied to the sample well on the device, the reagent will laterally flow on the surface of the test strip. If there is enough Toxoplasma IgM/IgG in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid test. By the means, the device can accurately indicate the presence of Toxoplasma IgM/IgG in the specimen.
Kit components: 5 test per box and/or 10 test kit per box in an individual foil pouch with a desiccant and disposable dropper, EDTA blood collection tube, Assay buffer bottle, Instruction manual
The FactView HBsAg Strip is a diagnostic assay used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma samples. Here's more information about this type of diagnostic test:
Purpose: The test is used for the diagnosis of hepatitis B virus (HBV) infection. HBsAg is a protein present on the surface of HBV particles and is the earliest serological marker of acute HBV infection. Detection of HBsAg indicates active HBV infection.
Principle: The FactView HBsAg Strip is typically an immunochromatographic assay that utilizes specific antibodies to capture HBsAg molecules in a patient's serum or plasma sample. The test is based on the principle of antigen-antibody binding, where HBsAg in the sample binds to specific antibodies immobilized on the test strip, resulting in the formation of visible test lines.
Components: The test kit usually includes test strips, sample droppers, buffer solutions, and desiccants. The test strips contain specific reagents and antibodies for capturing HBsAg from the serum or plasma sample.
Procedure: The test procedure involves collecting a small amount of serum or plasma from the patient and adding it to the sample well of the test strip. Buffer solution is then added, allowing the sample to migrate along the test strip. Results are typically visible within 15-20 minutes.
Interpretation: The appearance of colored lines on the test strip indicates the presence or absence of HBsAg in the patient's serum or plasma sample. A visible line in the control region indicates that the test is valid. An additional line in the test region indicates a positive result for HBsAg.
Sensitivity and Specificity: The FactView HBsAg Strip demonstrates high sensitivity and specificity for detecting HBsAg in serum or plasma samples. However, like all diagnostic tests, false-positive and false-negative results are possible and should be interpreted in conjunction with clinical findings.
Utility: The qualitative detection of HBsAg provides valuable information for diagnosing HBV infection, assessing disease status, and guiding patient management decisions. HBsAg positivity indicates active viral replication and infectiousness.
Limitations: While HBsAg testing is a valuable diagnostic tool, it has limitations, including the potential for false-positive results in low-prevalence populations and the inability to differentiate between acute and chronic HBV infection based solely on HBsAg positivity.
Overall, the FactView HBsAg Strip is an important tool for diagnosing HBV infection, allowing for timely intervention and management of patients with HBV-related liver disease. It aids in the prevention of HBV transmission and the implementation of control measures to reduce the burden of hepatitis B worldwide.
Cat No : COVAG025. GenBody COVID-19 Ag is an immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal and oropharyngeal swab from human.
The NeoPlexTM COVID-19 Detection Kit Assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from respiratory specimens* obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The NeoPlexTM COVID-19 Detection Kit is for use only under Emergency Use Authorization (EUA) in the US laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.�§263a, to perform high complexity tests.
Number of Reactions(Preps)/Kit : 96 wells
Brand : SD Biosensor
ICMR Approved : Yes
Result Time (Rapid Kits) : 1hr 40 mins
STANDARD E Dengue IgM ELISA analyzes IgM antibodies specific to Dengue virus in serum and plasma using enzyme linked immunosorbent assay.
Simple and easy to use - All necessary reagents included in the kit
Highest accuracy with all dengue serotypes(DEN1,2,3, and 4)
Performance
Sensitivity : 97.4% (77/79) / Specificity : 96.6% (346/358)
CE Approved Singclean COVID-19Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid,qualitative detection of antigen from COVID-19 in human nasal swab specimen.This test provides only a preliminarytest result. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confimed with alternative testing method(s) and clinical findings.
This rapid antigen test kit is the second test kit developed by Singclean Medical for COVID-19 testing on the basis of Colloidal Gold Method after Singclean COVID-19 lgG/IgM Test Kit, an antibody test, was launched globally in March.
Advantage
Results ready in 15 minutes
Accurate diagnostic tool for active infection
Easy to administer and read results
Affordable, no need for instrument, highly portable
Enable testing on a massive scale
For healthcare workers use only
Warnings
1. This test is not for at home testing, and should only be operated by healthcare workers.
2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Inadequate or inappropriate sample collection, storage, and transport may cause false test results.
Ionebio produces the iLAMP Novel-CoV19 Detection Kit, a real-time Reverse Transcription LAMP-PCR assay system. The test kits are widely used in South Korea, including at ports of entry into the country. Ionebio has secured a facility in the United States which can produce 1 million test per day. This PCR has a 20 minute test time.
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