Orient New Life Medical Co.,Ltd.
| Payment Terms | T/T, Western Union |
| Supply Ability | 2000000pcs/month |
| Delivery Time | 20-30days |
| Packaging Details | 1pc/pouch, 25pcs/box |
| Category | Fertility |
| Format | Strip/cassette |
| Specimen | Swab |
| Testing time | 5-15 minutes |
| Shelf Life | 24 Months |
| Application | CMV |
| Accruray | 98.63% |
| Brand Name | New Life |
| Certification | ISO13485,CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T, Western Union | Supply Ability | 2000000pcs/month |
| Delivery Time | 20-30days | Packaging Details | 1pc/pouch, 25pcs/box |
| Category | Fertility | Format | Strip/cassette |
| Specimen | Swab | Testing time | 5-15 minutes |
| Shelf Life | 24 Months | Application | CMV |
| Accruray | 98.63% | Brand Name | New Life |
| Certification | ISO13485,CE | Place of Origin | China |
| High Light | female fertility test kit ，pregnancy ovulation kit | ||
CMV Rapid Diagnostic test Cassette to detect Cytomegalovirus in human blood ,gold colloidal method, easily and quick
Intended Use:
The Cytomegalovirus Rapid Test is a rapid qualitative lateral flow test designed for the quantitive detection of Cytomegalovirus (CMV) in human serum/plasma samples.
Test Principle:
The Cytomegalovirus Rapid Test Device (Serum/Plasma) has been designed to detect CMV through visual interpretation of color development in the internal strip. The membrane was immobilized with antigens of CMV on the test region. During the test, the specimen is allowed to react with colored recombinant mouse anti-human IgM latex conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough CMV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready
to begin testing.
2. Remove the device from the sealed pouch and lay it on a flat and dry surface.
3. Using the provided pipette, add one drop of fresh specimen to the sample well.
4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoidcross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Read the result between 15-20minutes. Do not read results after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
PERFORMANCE CHARACTERS:
Table: CMV Rapid Test vs. EIA Test
|
Relative Sensitivity: 96.15% (86.80%-99.53%)* Relative Specificity: >99.9% (94.04%-100.0%)* Overall Agreement: 98.21% (93.70%-99.78%)* *95% Confidence Interval |
CMV Rapid Test | ||||
| + | - | Total | |||
| EIA Test | + | 50 | 2 | 52 | |
| - | 0 | 60 | 60 | ||
| 50 | 62 | 112 | |||
| ORIENT NEW LIFE MEDICAL CO., LTD. | |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
Company Details
Business Type:
Manufacturer,Exporter
Year Established:
2009
Total Annual:
10,000,000-15,000,000
Employee Number:
200~300
Ecer Certification：
Active Member
Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnosti... Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnosti...
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