Orawell Antibody Saliva HIV1/2 test kit
Oralwell Antibody saliva HIV 1/2 test is more suitable for home/personal test by saliva.
The OraWellHIV-1/2 Antibody Saliva Rapid Screen Test is designed for the use of buffered human fresh saliva as the specimen. Collecting specimen must follow standard clinical procedure. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
Do not place anything into the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection of oral fluid specimen.
1. Remove the saliva collector out of the pouch.
2. Pull out the collection swab from the collection chamber.
3. Place the collection swab into mouth and gently move around root of the teeth for about 5 minutes to let sufficient saliva be collected in the swab.
4. Remove the swab out of the mouth and place it inside the chamber.
5. Push the swab to squeeze out 1ml saliva to a dropper bottle which contains 1ml saliva dilution buffer. Make sure the total volume is around 2ml. Mixing well before using.
*Saliva specimens can be kept at room temperature if a test is performed within 24 hours after collection. The specimens must be stored at 2-8°C for two weeks before using. If the test is not performed within 2 weeks, saliva specimens should be frozen for prolonged storage. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeatedly freezing and thawing of specimens.
ASSAY PROCEDURE
1. Do not open foil pouch until ready to begin testing. Refrigerated test devices should be allowed to come to room temperature (15- 28°C) before opening the pouch.
2. Remove the device from the protective pouch and label the device with specimen identification. The product is sensitive to the presence of moisture. After opening the package, the test device should be used immediately.
3. Add 6 drops (250μl) of fresh saliva specimen to the sample well.
4. Read the result within 10 minutes. Observe the colored band developed over the control region indicating the assay is complete.
IMPORTANT: In order to prevent an incorrect reading, do not read the test results after 15 minutes. If the test is read after 15 minutes, the intensity of the colored bands may change or a new band may appear in test region (T). To avoid confusion, discard all test devices after interpreting results.
INTERPRETATION OF RESULT
POSITIVE: Presence of two visible, pink-colored bands, one in the control region (C) and the other in test region (T), indicates presence of HIV-1/2 antibodies in sample.
NEGATIVE: Presence of a single colored band in the control region (C) indicates the absence of HIV-1/2 antibodies or that the concentration of antibodies in sample is below the detection cut-off level.
INVALID: Results are invalid if no band appears in the control region, or a band appears only in the test region after 10 minutes. An invalid result may be due to improper assay procedures or damage to the device. The assay is inconclusive and the specimen should be re-tested using a new test device.
NOTE: Do not interpret results after 15 minutes. The test band intensity may be weaker or stronger than that of the control band, but a very faint band in the test region indicates that the concentration of HIV-1/2 antibodies in the sample is lower than the detection cut-off level. The sample should be re-tested or confirmed with a more specific method before a positive determination is made.
ASSAY COMPARISONS & EQUIVALENCY
Accuracy and equivalency comparisons of OraWell HIV-1/2 Antibody Saliva Rapid Screen Test were evaluated against 600 individual external WB-certified clinical laboratory samples. The results have been tabulated below.
OraWell Rapid Screen Test vs. WB
WB
HIV 1/2 Test
(+)
HIV 1/2 Test
(-)
Row
Totals
(+)
300
0
300
( - )
1
299
300
Col.Totals
301
299
600
When compared to WB , the percent agreement with OraWell HIV-1/2 Antibody Saliva Rapid Screen Test, positive samples were 300/300 or 100%. Negative samples recovered at 299/300 or 99.7%, while the overall relative accuracy obtained was 599/600 or 99.8%.
