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    HIV Syphilis CT NGH

- Product Name

Anti-HIV 1+2 Whole Blood/Serum/Plasma Test Cassette (Colloidal Gold)

- Storage and Stability

Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.

- Assay Procedure
1.    When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2.    Whole Blood/Serum/Plasma: Fill the capillary tube with specimen (about 20μl) not to exceed the specimen line as shown in the images below. For better precision, transfer specimen using a pipette capable of delivering a 20μl volume.
3.    Immediately add 2 drops (60-80ul) of buffer into the sample well.
4.    Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 20 minutes should be considered invalid.


- Results Interpretation
1. Positive:
1.1 If both the C line and test line 1 develop, the test indicates that the specimen contains anti-HIV-1 antibodies. The result is HIV-1 positive or reactive.
1.2 If both the C line and test line 2 develop, the test indicates that the specimen contains HIV-2 antibodies. The result is HIV-2 positive or reactive.

1.3 If the C line and both test lines (1 and 2) develop, the test indicates that the specimen is HIV positive or reactive. To differentiate the type of HIV infection, dilute the sample with sample diluent 1:50 or 1:100 and begin the test again in a new test cassette. All three test lines (1, 2 and C) may develop when tested with samples containing high titers of HIV-1 antibodies. To differentiate and to resolve antibody cross-reactivity, dilute the test specimen with sample diluent 1:50 or 1:100, then re-test the diluted specimen with a new test device. Only test line 1 and the C line will appear if the specimen contains antibodies to HIV-1. If test line 1, test line 2 and the C line all appear, the test indicates presence of antibodies to both HIV-1 and HIV-2.

Samples with reactive results should be confirmed with alternative testing method(s) such as PCR or ELISA and clinical findings before a final diagnostic decision is made.

2. Negative: If only the C line develops the test indicates that there is no presence of HIV antibodies in the specimen. The result is HIV-1 and HIV-2 antibodies negative or non-reactive.

3. Invalid: If no C line develops, the assay is invalid regardless of color development in the test lines as indicated below. Repeat the assay with a new device.

- Product properties
Product Format: Cassette

Products name: HIV 1+2 Whole Blood/Serum/Plasma Test Cassette

Methodology: Colloidal Gold

Specification: 4mm

Specimen: Whole Blood/Serum/Plasma

Reading Time: with 10-15 minutes

Service: OEM and ODM, Technology and Policy support

Shelf life: 24 months

Certificates: ISO13485, SGS