Our SARS-CoV-2 IgM/IgG Antibody Test Kits are single-use rapid immunochromatographic tests for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and venous whole blood (heparin, dipotassium EDTA, and sodium citrate). They are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
INTENDED USE
For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection.
FEATURES
Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2.
Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva.
Easy to use, easy results interpretation by naked eyes.
Test result available within 15minutes.
TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit.
RESULTS INTERPRETATION
Positive: A red line appears on the test line (T) and the control line (C).
NOTE: A positive result does not rule out co-infections with other pathogens.
Negative: Only the control line (C) appears, and no red line appears on the test line (T).
NOTE: A negative result does not exclude infection.
Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again.
- LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen.
- Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable.
- No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track.
- Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%)
- Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%).
[Product Name]: SARS-CoV-2 Antigen Test
[Product Code]: Cat# FP-318
[Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva
[Detection Method]: Colloidal Gold
[Reaction Time]: Within 15min
[Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1.
[Storage Conditions]: 2*C ~ 30*C
[Shelf Life]: 12 months
[CE Mark Registration No.]: RPS/99/2021.
The second brand in the world health organization test list
Colloidal Gold Method
This kit applies the principle lateral flow chromatographic immunoassay and uses capture method to detect specific IgM and IgG antibodies against novel coronavirus in human
specimens (serum, plasma and venous whole blood).
Product Name : COVID-19 SARS-CoV-2 IgM Antibody Test Kit
Product Description :
Material attachment is good. The shell of the detection card should be flat, the upper and lower covers should be closed evenly, and there should be no obviousgap.Thediluentshouldbeclearandfree offoreignmatter. 1.6 Size:thesizeofteststripshouldnotbelessthan2.5mm. 1.7 Liquidmigrationspeedshouldnotbelessthan10mm/min. 2.Minimumdetectionlimit TheminimumtestlimitreferenceproductsS1shouldbenegative,S2andS3shouldbepositive. 3.Negativecompliancerate 5copiesofnegativereferenceproductsof thetestcompanyshallbeallnegative,withanegativecompliancerateof100%. 4.Positivecompliancerate
5copiesofnegativereferenceproductsof thetestcompanyshallbeallpositive,withanegativecompliancerateof 100%. 5.Repeatability Test1copyoftheenterprisepositivereference,test10times,shouldbeconsistentcolor,arepositive. 6.Specificity 6.4 Cross Reaction: This product with vice influenza virus antibodies, influenza a virus, influenza b virus antibodies, pneumonia chlamydia, mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitisbsurfaceantibody,hepatitis cvirusantibody,treponemapallidumantibody,humanimmunodeficiencyvirus(HIV) antibodies,EBvirusantibody,measlesvirus,CMVantibodies,enterovirustype71,mumpsvirusantibody,varicella - zoster viruspositivesamples nocrossreaction. 6.5 Thereisnocross-reactionbetweenRF,ANAandAMA. 6.6 Interferingsubstance: (3) When bilirubin concentration =250 mol/L, hemoglobin content =9g/L, triglyceride content =15mmol/L,content of rheumatoid factor =80IU/mL, titer ofANA=1:240, anti-mitochondrial antibody (AMA) =80U/mL, content of mouse IgG=1000g/mL,therewillbenointerferencewiththetestresultsof thisproduct. (4) The commonly used antiviral drugs epiztin acid (=4mg/L), ribavirin (=40mg/L), interferon (=200mg/L), oseltamivir (=30mg/L), abidol (=40mg/L), levofloxacin (=200mg/L), azithromycin (=100mg/L), ceftriaxone (=400mg/L), meropenan(=200mg/L) havenointerferenceinthedetectionofthisproduct. 7. Hookeffect No hook effect was found in the test results of this product within the titer range of clinically positive samples of the novel coronavirusantibody.
Price of product ( USD price or FOB price) : $4.23
Product origin : China
Key Specifications/Special Features :
CE
FDA
Hospital professional testing and use, family and individuals can not use
Minimum Order Size and Packgaing details:
MOQ:10000pieces
25pieces/box box size:15*14*6.5cm ,150g/box
100boxes /CTN,CTN Size 72*62*36cm 21KG(without lancet and alcohol cotton)
The Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) adopts the solid phase colloidal gold immunochromatographic technology for the qualitative determination of IgM/IgG antibodies against SARS-CoV-2
SARS-CoV-2 IgG/IgM Cartridge
Kit include : 1 Test Box + 1 Cartridge + 1 UV Touch
SARS-CoV-2 IgG/IgM Kit is used for rapid and accurate screening of the COVID-19, which helps identify suspected patients and
reduce false negative rate. Rapid detection of recent SARS-CoV-2 infection
In ONLY 12 minutes
ONE-STEP operation
Single cartridge, NO additional buffers
TRFIA Europium particles displays Clear and Bright results
Dual capturing antigens (S and N) enhanced sensitivity
Important complement to PCR detection in COVID-19 diagnosis
WONDFO SARS-CoV-2 Antibody test kits (Later Flow Method), Rapid response 15 minutes
- Easy to use, no equipment required
- Multiple sample types, including fingerstick blood
- Instant result in 15 minutes
- CE marked in vitro diagnostics for professional use in the EU
- Measuring IgG/IgM
- Specificity 99.57%
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