Medical Device Typhoid Igg/Igm Rapid Test Kit

• Customization: Available
• Type: Test Strips & Test Tube, IVD Reagent
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Model NO.: DNSTYP33
• Quality Guarantee Period: Two Years
• Group: Adult
• Logo Printing: OEM
• Material: Plastic and Paper
• Package: 1PCS/Foil Pouch, 40 PCS/Valve Bag, 2000 PCS/Carton
• Types: Strip/Cassette
• Shipment: by Air or by Sea
• Specification(mm): Strip: 2.5, 3.0; Cassette: 3.0, 4.0
• Transport Package: Carton
• Trademark: Diagnos
• Origin: Jiangsu, China
• HS Code: 3822001000
• Production Capacity: 1000000 Pieces/Month

Product Description

Medical device Typhoid IgG/IgM rapid test kit

The Typhoid IgG/IgM Rapid Test is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. It is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human serum or plasma. Any reactive specimen with the Typhoid IgG/IgM Serm/Plasma Rapid Test must be confirmed with alternative testing method(s).

 

Details of products

Model Number:	DNSTYP33	Brand Name:	Diagnos and OEM
Power Source:	Manual	After-sale Service:	Online Technical Support
Specimen:	Whole Blood /Serum/Plasma	Format:	Strip/Cassette
Accuracy:	99.5%	Shelf Time:	24-36Months
Quality Certification:	FSC/CE/ISO13485	Warranty:	2 years

Product Information





Specimen Collection and preparation 

1. The  Typhoid IgG/IgM Rapid Test can be performed using  serum or plasma,or whole blood.
2. For serum or plasma specimen, separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days.  For long-term storage, specimens should be kept below -20°C
3. For whole blood specimen, drops of whole blood can be obtained by either finger tip puncture or veinpuncture. Do not use any hemolized blood for testing. Whole blood specimens should be stored in refrigeration (2°C-8°C) if not tested immediately. The specimens must be tested within 24 hours of collection.
4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing.  Specimens should not be frozen and thawed repeatedly.
5. If specimens are to be shipped, they should be packed in compliance with national regulations covering the transportation of etiologic agents.

                                                                

Assay Procedure

Allow the test device, buffer, specimen to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the test device on a clean and level surface. Be sure to label the device with specimen's ID number.

3. For Whole blood test

Apply 2 drops of whole blood (about 40 µl) into the sample pad.Then add 1 drop of Sample Diluent.
 

For serum or plasma test

Fill the pipette dropper with the specimen.

Holding the dropper vertically and transfer 2-3(about 60-80 µl) drops of serum or plasma to the specimen well (S) of the test device and start the timer.

4.    Wait for the red line(s) to appear. The result should be read at 15 minutes. 

Note: 

1. Add 1 drop of Saline or Phosphate-Saline buffer (common buffers used in clinic, not provided in the kit) into the sample well if flow migration is not observed within 30 seconds in the result window, which could occur with a highly viscous specimen.

2. Positive results can be visible in as short as 1 minute.

3. Don't read result after 15 minutes. Discard the test device properly after interpreting the result to avoid confusion.

 Interpretation of Assay Result

1. NEGATIVE RESULT: If only the C band is present, the absence of any burgundy color in the both T bands (T1 and T2) indicates that no anti-S. typhi antibody is detected. The result is negative.

2. POSITIVE RESULT:

  2.1 In addition to the presence of C band, if only T1 band is developed, the test indicates for the presence of anti-S. typhi IgM.  The result is positive.
  2.2 In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of anti- S. typhi IgG. The result is positive.
  2.3 In addition  to the presence of C band, both T1 and T2 bands are developed, this indicates for the presence of anti-S. typhi IgG and IgM.. The result is also positive.

 INVALID: If no C band is developed, the assay is invalid regardless of any burgundy color in the T bands as indicated below. Repeat the assay with a new device.

Storage and Stability 



Packing & Delivery

1.Strip:MOQ of 5000pcs,1 test and 1 desiccant in a single pouch,5000pcs packed one carton;
   Cassette:MOQ of 2000pcs,1 test and 1 desiccant in a single pouch,2000pcs packed one carton;

2. Shipping methods: By sea or by air.
 

Company Profile


Our Advantages:



FAQ
Q1.What's the method you use to do the test?
A: Colloidal Gold Method.

Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.

Q3: What's ur packing of the tests?
A: If you choose the low cost, we will suggest u the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.

Q4: What's the main differences when comparing products from different suppliers?
A: You can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.

Q5: How can i distinguish a good test kit?
A: You can judge from the 4facts:
1.Technical data: Such as the accuracy, specificity and sensitivity.
2.Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of
antibodies labeled on NC membrane. Shelf life will be shorten down.
3. Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
4. Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.

 

Q6: How can I get some samples?

1.We may provide some samples, but the postage and samples fee will be paid by yourself. The post charges and samples fee will be deducted from payment for goods after we bargained on the order .

2. You can give us your collect account (just like DHL, UPS etc) and detail contact information. Then you can pay the freight direct to your local carrier company.

Contact Us

Promise: Great Service is our mission, high quality is our obligation! As we strongly believe that QUALITY and SINCERE are very important among business trip !

Welcome to enquiry!

Contact Name:Lyn Fang
E-mail:sale10@diagnosbio. com
  
Mobile:[phone]