Sars-Cov-2 Igg/igm Kit

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).

SARS-CoV-19 IgG/IgM test kit (15min showing result)
Manufacturer: Guangzhou Wanfo Biotech Co., Ltd. a China listing company
Certificates: CE certificate, China NMPA approval (export allowed), no FDA approval
The price is $5.5/test (FOB)
Max delivered quantity: 100,000/weekly
More details please enquire Barry Liu whatsapp: +8617810331113
sample available: 20 test & DHL delivery: $200
Download introductions: https://kdocs.cn/l/sLLC9O6rc

Cat. No : 5513C. COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19

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 and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection.

FEATURES
Coated with carefully selected specific Nucleocapsid and Spike protein antigen.
Detection for IgM and IgG antibodies simultaneously.
Simple operation, easy result interpreted.
Rapid test within 15 minutes.

RESULTS INTERPRETATION
Positive:
1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies.
2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody.
3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody.

Negative:
1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative.

Invalid:
1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested.
2. The test result is invalid after 15 min.

CLINICAL PERFORMANCE
- Positive Percent Agreement (PPA) = 91.07% (153/168) (95% CI: 85.70%-94.92%).
- Negative Percent Agreement (NPA) = 95.37% (103/108) (95% CI: 89.53%-98.48%).
- Overall Rates of Agreement (ORA) = 92.75% [(153+103)/ (168+108)] (95% CI: 89.03%-95.52%).

[Product Name]: SARS-CoV-2 IgM/IgG Duo Test
[Product Code]: Cat# FP-319
[Sample Type]: Whole blood /Plasma/Serum
[Sample Volume]: 20L /10L/10L
[Detection Method]: Colloidal Gold
[Reaction Time]: 10-15min
[Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL.
[Storage Condition]: 2oC ~ 30oC
[Shelf Life]: 12 months
[CE Mark Registration No.]: RPS/499/2021.

RT-PCR TEST FOR SARS-CoV-2(COVID-19)

PCR based test is the gold standard for detection of SARS-CoV-2 infection. The kit is based on the reverse transcription-polymerase chain reaction (RT-PCR), amplifying two target sequences on the viral ORF1ab and N genes, as recommended by both China and U.S. CDC. By monitoring the reaction signal in real-time and comparing with a cut-off Ct value, the virus can be detected qualitatively. The kit contains all necessary components for the RT-PCR assay as well as a positive and a negative template control for quality control.

Two target sequences detected in one tube: Open Reading Frame 1ab (ORF1ab) & SARS-CoV-2 N gene
Stable amplification with good repeatability
Positive and Negative template control for quality assurance

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 Rapid Test Kit
Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma
Product Format: 25 tests/kit
Kit Contents: test card, diluent, capillary, lancet, and instruction for use.
Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision
100% Concordant across 3 lots with CV ±5%
Performance Comparison (A)
China Validation Test
Positive Samples 100 / 102
Sensitivity: 98.04%
Negative Samples 491/492
Specificity: 99.80%
Overall Accuracy: 99.49%
Performance Comparison (B)
Positive Samples 23 / 25
Sensitivity: 92%
Negative Samples 25 / 25
Specificity: 100%
Overall Accuracy: 96%

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