[Equipment required for testing]

l The timer

l Test paper card (no, record paper can be used instead)

l Disposable test tube

l Centrifuge (plasma only)

[specimen collection]

Serum or plasma is separated as soon as possible during specimen collection to avoid hemolysis. Fresh specimens should be used when testing. Specimens without inspection in time, can be in 2 ℃ 8 ℃ refrigerated for three days. Long-term preservation should be frozen in - 20 ℃, avoid repeated freezing and thawing.

[operation steps]

Please read the instructions carefully before the test, and restore the test paper and blood sample to room temperature before use.

1. Remove the test paper from the original packaging aluminum foil bag and use it as soon as possible within 1 hour.

2. For the test strip, insert the direction indicated by the arrow of the test strip into the specimen liquid level in the specimen collector until the marker line, and do not immerge the reagent strip beyond the marker line. Make sure the immersion time is longer than 10-15 seconds. Then remove the reagent bar from the specimen collector, paste it onto the test card, and observe the test results.

For the test paper card, the test paper is placed on a flat platform, and the sample is added to the sample hole (S) of the test paper after sampling by the drip tube.

3. Wait for the occurrence of the magenta band, and the test results shall be read in 10 minutes. After 20 minutes, the verdict is invalid.

[result determination]

Positive (+):Two purplish red bands appear. One is in the test area (T) and the other is in the quality control area (C). The positive results showed that the specimen contained antibodies to HCV virus.

Negative (-):Only one purple-red strip appears in the quality control area (C), no purplish red band appears in the test area (T). Negative results indicated that HCV antibody was not detected in the sample.

invalid:No purplish red strip appears in quality control area (C), indicating incorrect operation or deterioration of the test paper. In this case, read the instructions carefully again and retest with a new test paper. If the problem persists, stop using the lot number immediately and contact the local supplier.

Pay attention to: the purple and red bands in the test area (T) can show the color depth. However, in the specified observation time, regardless of the color of the color band, even if only a very weak color band should be judged as a positive result.

[sensitivity and specificity]

HCV colloidal gold test paper was used to test 468 serum samples, and compared with ELISA reagent bar, the test showed that the sensitivity and specificity of HCV colloidal gold test paper could reach 98% and 99.8% respectively.

[usage restrictions]

1. HCV colloidal gold test paper is suitable for testing serum or plasma samples.

2. Improper operation or interference in specimens may lead to wrong results.

3. The HCV colloidal gold test paper is only a qualitative screening for the presence of hepatitis c virus antibodies and cannot determine the content of the virus in the blood sample.

4. Test results should be read at 10 minutes and invalid after 20 minutes.