Rapid test kit Toxo Rubella cmv hsv torch lgM lgG CMV rapid test kit1

3 year ago

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Changchun ZYF science and technology CO.,LTD

3 year

Product details

pecification

Product Name
(TORCH) TOX-IgM, RV-IgM, CMV-IgM, HSV-Ⅰ-IgM, HSV-Ⅱ-IgM 5-in-1 Combo Rapid Test Panel (Immunochromatography)

Intended Use
Used for the qualitative detection of TORCH (TOX-IgM, RV-IgM, CMV-IgM, HSV-Ⅰ
-IgM, HSV-Ⅱ-IgM) antibody in human serum or plasma to determine if someone is infected by TORCH.

Main Components

TOX-IgM: Sample pad, colloidal gold labeled anti-human IgM, nitrocellulose membrane coated with recombinant TOX antigen and goat anti-mouse IgG antibody, absorbent pad, PVC board RV-IgM: Sample pad, colloidal gold labeled anti-human IgM, nitrocellulose membrane coated with recombinant RV antigen and goat anti-mouse IgG antibody, absorbent pad, PVC board CMV-IgM: Sample pad, colloidal gold labeled anti-human IgM, nitrocellulose membrane coated with recombinant CMV antigen and goat anti-mouse IgG antibody, absorbent pad, PVC board
HSV-Ⅰ-IgM: Sample pad, colloidal gold labeled anti-human IgM, nitrocellulose membrane coated with recombinant HSV-Ⅰ antigen and goat anti-mouse IgG antibody, absorbent pad, PVC board HSV-Ⅱ-IgM: Sample pad, colloidal gold labeled anti-human IgM, nitrocellulose membrane coated with recombinant HSV-Ⅱ antigen and goat anti-mouse IgG antibody, absorbent pad, PVC board

Storage and Expiry
Store as packaged in the sealed pouch at 4-30°C, keep out of hot and direct sunlight, keep in dry place,
valid for 24 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and
cold winter to avoid high temperature or freeze-thaw. The product is humidity-sensitive and should be
used immediately after being opened.
Care should be taken to protect the components of the kit from contamination. Do not use if there is
evidence of microbial contamination or precipitation. Biological contamination of dispensing
equipment, containers or reagents can lead to false results.

Test Procedure
Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate
to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity: 20%~90%, Temp: 10℃-50℃)
1. Take off the outer packing, put the cassette onto the desk with the sample window up.
2. Apply 3 full drops of serum / plasma (80μl-100μl) vertically into the sample hole of cassette. Avoid
air bubble in the pipette, a bubble may prevent the complete transfer of sample and invalidate the test.
Use a new pipette for each test performed, even if using the same sample.
3. Observe the test results immediately within 15~30 minutes, the result is invalid over 35 minutes.

Result Judgment
POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the
other line should be in the test region (T).
NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in
the test region (T).The negative result does not indicate the absence of analytes in the sample, it only
indicates the level of tested analytes in the sample is less than cut-off level.
INVALID: No colored lines appear or control line fails to appear, indicating that the operator error or
reagent failure. Verify the test procedure and repeat the test with a new testing device.

Note:
1. Any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the sample.
2. Insufficient sample volume, incorrect operating procedure or expired tests are the most likely

reasons for control line failure.

3. Control line color intensity of different items on the same cassette may be different, it is a normal phenomenon. The strength of the quality control line doesn’t indicate the quality problem of the reagent, a test result that is clearly visible demonstrates the reagent is effective.

Our main products cover Medical Consumables, Rapid Test Kit, Urinalysis Reagent Strip, Biochemistry Analyzer, Hematology Analyzer, POCT Analyzer,

Rapid test kit Toxo Rubella cmv hsv torch lgM lgG CMV rapid test kit

Manufacturing procedure

Packing & Delivery

Company Profile

Established in Year 2014,CHANGCHUN ZYF SCIENCE AND TECHNOLOGY Co., Ltd. is a high-tech enterprise devoted to the R&D, manufacturing, and sales of high-quality diagnostic products including laboratory equipment and clinical diagnostic reagents. We can offer more than 30 kinds of urine analysis strips sold well and enjoyed high reputation from both domestic and overseas markets. Based on the principle of "customer first, quality first", our products continue to cover world-wide markets with the advantages of stable performance and high accuracy. We registered MR International Healthcare Technology Co., Ltd. in Hong Kong for overseas sales. Through MR, we also possess some manufacture facilities in Zhejiang, Guangdong and Jiangsu provinces of China in order to help reduce the cost while caring about the quality. We are committed to provide most reliable medical devices and solutions to people in every corner of the earth. Accomplishing the mission of "maximizing the reliability of medical products" is our goal. We do care about obtaining the trust from our partners and patients. We are dedicated to innovation in the fields of Rapid Test, POCT, In-Vitro Diagnostics, and Medical Consumables, such as vacuum tubes, tube holders, etc.

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