One Step Medical diagnostic Rapid Test HIV/HCV/syphilis/Malaria/Dengue

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Product Overview

Description

Our Adantages

DIAGNOS-01 

One Step Medical diagnostic Rapid Test HIV/HCV/syphilis/Malaria/Dengue

       

Product name

One Step Medical diagnostic Rapid Test HIV/HCV/syphilis/Malaria/Dengue

Shelf time

24-36 month

OEM time

15-35 days

Certificate

CE/ISO13485/FSC

Specimen

whole blood

Format

Cassette

Size

Strip: 2.5mm/3.0mm

 

Cassette :3.0mm/4.0mm

Usage

Read results within 10-15 minutes

 

Test procedure

 

INTRODUCTION

For whole blood:

 Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be refrigerated at 2-80C. Freezing is recommended if the storage periods are more than 3 days. They should be brought to room temperature before testing. Using the specimen after long-term storage of more than three days can cause non-specific reaction. When stored at 2-8 0C, the whole blood sample should be used within three days.

 

ASSAY PROCEDURE

 Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

 Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

 Step 3: For whole blood sample: Fill the dropper with the specimen then add 1 dropper of specimen(about 10uL).

Then add 2 drops (about 60-100 μL) of Sample Diluent immediately into the sample well (S well)

Step 4: Read the result within 15 minutes. Don’t read results after 30 minutes. 

 Negative

 Only the C band shows color development. The T band shows no color development.

 Positive 

Both C and T bands show color development.

 The appearance of any burgundy color in the T band, regardless of intensity, must be considered as presence of the band.

 Invalid:

 If no C band is developed, the assay is invalid regardless of color development  on the T band as indicated below. Repeat the assay with a new device.

  PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use test kit beyond expiry date.

3. The test device should not be reused.

 

 

 

 dengue NS1-1

 

 syphilisDNS HBSAGDNSHCV

 

 

2.4305 s.