Immunoassay

Test Type Professional Use Only
Intended Use Detection of nucleocapsid antigens to SARS-CoV-2 virus
Specimen Type Nasopharyngeal Swab
Testing Time 20~30 mins
Specimen Volume 3 drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity 90.6 % (Ct value <34)
Specificity 100.0 %
Pack Size 25 tests/Box
Test Type Professional Use Only
Intended Use Detection of specific antigens to SARS-CoV-2, Influenza A and Influenza B virus
Specimen Type Nasopharyngeal Swab
Testing Time 20~30 mins
Specimen Volume 3 drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity SARS-CoV-2 : 93.1%
Influenza A : 97.4%
Influenza B : 95.7%
Specificity SARS-CoV-2 : 100.0%
Influenza A : 100.0%
Influenza B : 100.0%
Pack Size 25 tests/Box
Test Type Professional Use Only
Intended Use Detection of Hepatitis B virus surface antigen (HBsAg)
Specimen Type Whole blood, Serum, Plasma
Testing Time 20~30 mins
Specimen Volume 50ul + Dilution Buffer 2 Drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity 99.3 %
Specificity 100.0 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of specific antibodies to Treponema pallidum
Specimen Type Whole blood, Serum, Plasma
Testing Time 20~30 mins
Specimen Volume 20ul + Dilution Buffer 3~4 Drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity 99.5 %
Specificity 100.0 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of Influenza A&B antigens
Specimen Type Nasopharyngeal Swab
Testing Time 20~30 mins
Specimen Volume 3~4 Drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity Influenza A : 98.5%
Influenza B : 91.1%
Specificity Influenza A : 100.0%
Influenza B : 97.8%
Pack Size 25 tests/Box
Test Type Professional Use Only
Intended Use Detection of Dengue NS1 antigen
Specimen Type Whole blood, Serum, Plasma
Testing Time 20~30 mins
Specimen Volume 50ul + Dilution Buffer 2 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity 93.3 %
Specificity 97.4 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of Dengue IgG and IgM antibodies
Specimen Type Whole blood, Serum, Plasma
Testing Time 20~30 mins
Specimen Volume 10ul + Dilution Buffer 3 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity 96.8 %
Specificity 97.6 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of Hepatitis C virus antibody
Specimen Type Whole blood, Serum, Plasma
Testing Time 20~30 mins
Specimen Volume 10ul + Dilution Buffer 3 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity 98.4 %
Specificity 98.2 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of specific antibodies to all isotypes of HIV 1/2
Specimen Type Whole blood, Serum, Plasma
Testing Time 20~30 mins
Specimen Volume Whole blood : 20ul + Dilution Buffer 3~4 Drops
Serum, Plasma : 10ul + Dilution Buffer 3~4 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity HIV-1 : 100.0 %
HIV-2 : 100.0 %
Specificity HIV-1 : 100.0 %
HIV-2 : 100.0 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of Malaria Plasmodium falciparum specific Histidine Rich Protein 2 (HRP-2)
Specimen Type Whole blood
Testing Time 20~30 mins
Specimen Volume 5ul + Dilution Buffer 3~4 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity 99.0 %
Specificity 99.0 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of Malaria Plasmodium falciparum specific Histidine Rich Protein 2 (HRP-2) and Plasmodium species specific pLDH
Specimen Type Whole blood
Testing Time 20~30 mins
Specimen Volume 5ul + Dilution Buffer 3~4 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity 99.0 %
Specificity 99.0 %
Pack Size 50 tests/Box
Test Type Professional Use Only
Intended Use Detection of Respiratory Syncytial Virus (RSV) antigens
Specimen Type Nasopharyngeal Swab
Testing Time 15~30 mins
Specimen Volume 3~4 Drops
Storage Condition 2~40℃ (36~104℉)
Sensitivity 93.0 %
Specificity 99.0 %
Pack Size 25 tests/Box
Test Type Professional Use Only
Intended Use Detection of Adenovirus serotype 40 and 41
Specimen Type Stool
Testing Time 15~30 mins
Specimen Volume 3~4 Drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity 98.0 %
Specificity 98.0 %
Pack Size 25 tests/Box
Test Type Professional Use Only
Intended Use Detection of Adenovirus antigens in respiratory specimens
Specimen Type Nasopharyngeal Swab
Testing Time 15~30 mins
Specimen Volume 3~4 Drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity 95.0 %
Specificity 98.0 %
Pack Size 25 tests/Box
Test Type Professional Use Only
Intended Use Detection of Rotavirus Group A antigen
Specimen Type Stool
Testing Time 15~30 mins
Specimen Volume 3~4 Drops
Storage Condition 2~30℃ (36~86℉)
Sensitivity 92.0 %
Specificity 96.0 %
Pack Size 25 tests/Box
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