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Changchun Research Institute For Mechanical Science Co., Ltd.

Supplier From China
Jun-10-13
Supplier : Testing machine, straightening machine, tensile testing machine, compressing testing machine

Established: 1959

Verification Status



Contact Details:
118 Guigu Street
Changchun 130012
Jilin China


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Capacity (n): 10/20/30/50/100
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Pressure platen size: 230mm x 290mm
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Type: immunoassay system
Brand name: ntbio/oem/private label
Place of origin: british columbia, canada
Size: 60mm x 300mm
Cut-off value: 1000 ng/ml
Sensitivity: 99.5%
Specificity: >99.7%
Specimen: urine .
Jul-30-10
 
Intended use:
Toxoplasma IGG/IGM rapid test is a rapid immunochromatographic test for the simultaneous detection of IGM and IGG antibodies to toxoplasma gondii in human serum/plasma. The test can be used as a screening test for toxoplasma infection and as an aid for differential diagnosis of the self limiting primary toxoplasma infections and the potentially fatal secondary toxoplasma infections in conjunction with other criteria.

Test principle:
The toxoplasma IGG/IGM rapid test is a lateral flow chromatographic immunoassay. The test cassette consists of:

1) A burgundy colored conjugate pad containing toxoplasma recombinant envelope antigens conjugated with colloid gold (toxoplasma conjugates) and rabbit igg-gold conjugates,

2) A nitrocellulose membrane strip containing two test bands (t1 and t2 bands) and a control band (c band). The t1 band is pre-coated with the antibody for the detection of IGM anti-toxoplasma, t2 band is coated with antibody for the detection of igg anti-toxoplasma, and the c band is pre-coated with goat anti rabbit IGG.

Absence of any t bands (t1 and t2) suggests a negative result.
The test contains an internal control (c band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit igg/rabbit igg-gold conjugate regardless of the color development on any of the t bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

Reagents and materials supplied :
1. Test cassette individually foil pouched with a desiccant.
2. Plastic dropper
3. Buffer
4. Package insert.

Storage and stability:
The kit must be stored at 2-30pc.

Warning and precautions:
1. For in vitro diagnostic use only. Not for medicinal use.
2. Do not use beyond expiry date.
3. Read the instructions careful y before performing the test.
4. Handle all specimen as potential y infectious.
5. Follow standard biosafety guidelines for handling and disposal of potential y infective material.

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