Flu A&B and Covid -19 Antigen Combo Test

INTENDED USE
Flu A&B and Covid -19 Antigen Combo Test is rapid chromatographic assay used for qualitative detective antigens in Human nasopharyngeal swab spcimens
Specimen: Human nasopharyngeal swab spcimens
Format: Cassette
Model NO: BB120-40

Flu A:
Sensitivity: 98.7%,Specificity:98.3% Accuracy:98.5%
Flu B:
Sensitivity: 98.8%,Specificity:98.2% Accuracy:98.5%
Antigen Test:
Sensitivity: 97.5%,Specificity:100% Accuracy:98.8%
Dimension: 4.0mm strip
Quick Result :Read result within 10-15 minutes.
Packing：25T/box,1500Ts/ctn
Shelf Life:24months
Certificate:CE,ISO13485
 

SPECIMEN PREPARATION
1.The collection method of nasopharyngeal swab is shown in Figure 1 to 4.
Figure 1. Remove a nasopharyngeal swab from the pouch.
Figure 2. Place the swab into one of patient’s nostrils until reaches the posterior nasopharynx.
Figure 3. Slowly rotate the swab 3-5 times over the surface of the posterior nasophanynx.
Figure 4. Remove the swab from the nasalcavity.
2.Sample processing:
Figure 5. Insert the swab in collection tube to the bottom,rotate and squeeze the swab 10 times.
Figure 6. Leave the swab in the collection tube for 1 minute.
Figure 7. Rotate and squeeze the swab 3 times.
Figure 8. Take out and discard the swab.

TEST PROCEDURE
Read the instruction first prior to testing.Bring the pouched test to room temperature prior to testing.Do not open the pouch until ready to begin testing.
1.Remove the test from the sealed pouch.Lay it on a flat,clean and dry surface.
2.Place the test cassette on a flat and clean surface. Using the provided pipette,add 3 drops retained solution to the sample well.
3.Read results within 10-15 minutes.

INTERPRETATION OF RESULTS

Positive:Control line and T line appear in the show window.
Negative:Only one line appears in Control area, no line appears in T area.
Invalid:If no line appears in the control area,the test results are invalid regardless of the presence or absence of line in the test area.