Flatrufflednoodles, RMT.

Test Dengue NS1Ag Dengue IgG/IgM HBsAg HCV

Causative Agent Dengue Virus in Aedes aegypti Hepatitis B Virus Hepatitis C Virus
Test Kit HISENS Dengue Duo SD Bioline HBsAg Rapid Anti-HCV
Principle In-vitro immunochromatographic assay In-vitro immunochromatographic assay Immunochromatographic Assay
Detects Antigen Antibody Antigen Antibody
Antigen NS1Ag Hepatitis B Surface Antigen
Antibody Dengue IgM/IgG Anti-Hepatitis B Surface Antigen Anti-HCV
Active Dengue NS1 Rapid Test Dengue IgG/IgM Rapid Test • The anti-HBs in the antibody colloidal gold Sample pad: HCV antigen colloidal gold conjugate is
Ingredient • GOLD CONJUGATE: Mouse monoclonal • GOLD CONJUGATE: Recombinant conjugates: mouse monoclonal antibody-colloidal embedded
anti-dengue NS1 - gold colloid Dengue virus envelope protein - gold gold conjugates
• TEST LINE: Mouse monoclonal anti- colloid • Test zone: mouse monoclonal anti-HBs antibody Test strip membrane: antibody-binding protein
dengue NS1 • TEST LINE G: Mouse monoclonal anti- • Control zone: immobilized goat anti-mouse IgG
• CONTROL LINE: Goat anti-mouse IgG human IgG antibodies
• TEST LINE M: Mouse monoclonal anti-
human IgM
• CONTROL LINE: Rabbit anti-dengue IgG
Storage 1-30 degrees Celsius 2-30 degrees Celsius
Sensitivity 92.4% 94.2% 100% 100%
Specificity 98.4% 96.4% 100% 97-99%
Specimen Serum (100 uL or 4 drops) Serum (5 uL) Plasma/Serum (100 uL) Plasma/Serum (10 uL or 1 drop )
Diluent 90 uL or 4 drops (package insert) 90 uL or 4 drops (package insert) 2 drops
100 uL or 4 drops (lab manual) 100 uL or 3 drops (lab manual)
Incubation RT for 15-20 mins RT for 15-30 mins RT for 20 mins RT for 15 mins; DO NOT READ AFTER 20 MINS
Reading & Result Reading Interpretation
Interpretation (+) Control NS1Ag Negative; NS1Ag absent or present in below detectable levels; Result Reading Interpretation Result Reading Interpretation
(-) Test (+) C HBsAg Absence of (+) C Anti-HCV Absence of
(-) IgG, IgM Dengue IgG/IgM IgM and IgG Ab absent or present in below detectable (-) T negative active Hepatitis B (-) T negative infection from
Negative levels infection HCV
(+) Control NS1Ag Positive Presence of NS1Ag indicates early dengue infection; (+) C HBsAg Presence of (+) C Anti-HCV Presence of
(+) Test (+) T positive active Hepatitis B (+) T positive infection from
(-) IgG, IgM IgG and IgM Ab absent or present in below detectable infection HCV
levels (-) C INVALID Repeat test using (-) C INVALID Repeat test
(+) Control NS1Ag Negative; NS1Ag absent or present in below detectable levels; a new device using a new
(-) Test device
(+) IgG Dengue IgG Patient has a secondary dengue infection or was
(-) IgM Positive previously infected with dengue
(+) Control NS1Ag Negative; NS1Ag absent or present in below detectable levels;
(-) Test
(-) IgG Dengue IgM Presence of IgM Ab indicates primary dengue infection
(+) IgM Positive
(+) Control NS1Ag Positive; Presence of NS1Ag indicates early dengue infection;
(+) Test
(-) IgG Dengue IgM Presence of IgM Ab indicates a primary dengue infection
(+) IgM Positive
(+) Control Dengue IgG and NS1Ag absent or present in below detectable levels;
(-) Test IgM Positive
(+) IgG, IgM Presence of both IgM/IgG Ab indicates either a late
primary infection or early secondary infection
(-) Control INVALID Retest specimen using new device

Confirmatory Acute phase: NAAT + IgM Ab Test; NS1 ELISA + IgM detection Hepatitis Panel HCV RNA
Convalescent phase: IgM recommended primary test
GOLD STANDARD: RT PCR – can also determine which DENV serotype is the infecting the patient

*C = Control; T = Test
Flatrufflednoodles, RMT.

Test HIV nCOV

Causative Agent Human Immunodeficiency Virus 2019 Novel Coronavirus
Test Kit HiSens HIV ½ Card 2019 nCOV Ab Test
Principle Immunochromatographic assay Lateral Flow Chromatographic Immunoassay
Detects Antibody Antibody
Antigen HIV-1 Antigen; HIV-2 Antigen COVID-19 Antigen
Antibody Anti-HIV-1; Anti-HIV-2 COVID-19 IgM/IgG
Active Gold conjugate: Recombinant HIV-1/2 antigen (gp41, p24, gp36) Test panel: Recombinant SARS-COV-2 antigen (S1 and NP proteins), and mouse IgG antibodies
Ingredient Test Band 1: Test Line 1 (HIV-1) -1, 2 C labelled with colloidal gold as tracer
 Precoated with Recombinant HIV-1 capture antigen (gp41, p24)
Nitrocellulose membrane
Test Band 2: Test Line 2 (HIV-2) IgM: mouse anti-human monoclonal IgM Abs
 Precoated with Recombinant HIV-2 capture antigen (gp36) IgG: mouse anti-human monoclonal IgG Abs
Control: goat anti-mouse IgG Abs
Storage Test kit: 2-30 degrees Celsius 4-30 degrees Celsius
Sensitivity 100% (Combined): 100%
Specificity 99.6% (Combined): 97.5%
Specimen Plasma/Serum (10 uL); Whole blood (20 uL) Plasma/Serum (10 uL); Whole blood (20 uL)
Diluent 3 drops (100 uL) 2 drops (80 uL)
Incubation RT for 5- 20 mins (package insert) RT for 15 mins
Reading &
Result Reading Interpretation Result Reading Interpretation
Interpretation
(+) Control Negative for Anti- Absence of infection from (+) Control Negative for COVID-19 Absence of antibodies to COVID-
(-) 1 HIV 1 and Anti- HIV-1 and HIV-2 (-) IgG IgG and IgM Ab 19
(-) 2 HIV 2 (-) IgM

(+) Control Positive for Anti- Presence of infection (+) Control Positive for COVID-19 IgG Patient has had a previous
(+) 1 HIV-1 from HIV-1 (+) IgG Ab COVID-19 infection or Patient is
(-) 2 (-) IgM recovering from COVID-19
infection
(+) Control Positive for Anti- Presence of infection (+) Control Positive for COVID-19 IgM Patient has an early or current
(-) 1 HIV-2 from HIV-2 (-) IgG Ab COVID-19 infection or acute
(+) 2 (+) IgM COVID-19 infection

(+) Control Positive for Anti- Presence of infection (+) Control Positive for COVID-19 IgG Patient has a late acute COVID-19
(+) 1 HIV-1 and Anti- from HIV-1 and HIV-2 (+) IgG and IgM Abs infection and recovering
(+) 2 HIV-2 (+) IgM

(-) Control INVALID Repeat test using a new (-) Control INVALID Repeat test using a new device
device

Confirmatory Western Blot RT-PCR : remains positive 3 months after infxn; Chemiluminescent Immunoassay: detects Ag

*C = Control; T = Test
Flatrufflednoodles, RMT.

Test MALARIA TYPHOID IgG/IgM SYPHILIS

Causative Agent Plasmodium spp. in Female anopheles mosquito Salmonella typhi ; Salmonella paratyphi 2019 Novel Coronavirus
Test Kit SD Malaria Ag P.f/P.v Aria TYPHOID IgG/IgM 2019 nCOV Ab Test
Principle Lateral Flow Immunochromatographic Assay Lateral Flow Immunochromatographic Assay Sandwich Immunoassay
Method In-vitro immunochromatographic assay In-vitro immunochromatographic assay Immune Capture Method
Detects Antigen Antibodies Antibody
Antigen Malaria Antigen COVID-19 Antigen
Antibody Typhoid IgG/IgM COVID-19 IgM/IgG
Active Gold Conjugate: Mouse monoclonal Abs specific to P.f HRP-II- gold colloid Test cassette individually foil pouched with desiccant. Nitrocellulose membrane strip:
Ingredient (0.1±0.02ug), Mouse monoclonal Abs specific to pLDH of Plasmodium vivax – gold  A burgundy-colored conjugate pad containing recombinant S.typhi  Test band: recombinant syphilis antigen
colloid (0.1±0.02ug) H and O antigen conjugated with colloid gold (typhoid conjugates)  Control: an antibody to syphilis
Test line P.f: Mouse monoclonal Abs specific to P.f HRP-II- gold colloid (0.5±0.1ug) and rabbit IgG gold conjugates
Test line P.v: Mouse monoclonal Abs specific to pLDH of Plasmodium vivax Nitrocellulose membrane strip containing 2 test lines: Conjugate pad: TP Ag 1, another syphilis antigen, coupled
(0.5±0.1ug)  M Band is pre-coated with monoclonal anti-human IgM for the with colloidal gold particles is dried on the conjugate pad
Control: Goat anti-mouse IgG (1.0±0.2ug) detection of IgM anti-S.typhi.
 G Band is pre-coated with monoclonal anti-human IgG for the
detection of IgG anti-S.typhi reagents
 C Band is pre-coated with goat anti-rabbit IgG
Storage Test kit and diluent: 1-40 degrees Celsius (DO NOT FREEZE) Test kit: 2-30 degrees Celsius 2-30 degrees Celsius
Before performing the test: should be brought to 15-40 degrees Celsius minimum During test: 15-30 degrees Celsius
of 30 mins prior to test
Sensitivity 100% (Relative) - IgM: 91.2%; IgG: 92.9% 99.61%
Specificity 99.6% (Relative) - IgM: 99.0%; IgG: 99.0% 99.83%
Specimen Whole blood (5 uL) Plasma/Serum (30-45 uL); Whole blood (40-50 uL) Plasma/Serum (10 uL); Whole blood (20 uL)
Diluent 3 drops (100 uL) 1 drop (35-50 uL) 2 drops (80 uL)

Composition: Bovine Serum Albumin (q.s); 200mM Phosphate Saline Buffer (q.s);
Triton X-100 (q.s); Sodium azide(q.s)
Incubation RT for 15- 30 mins (package insert) RT for 15 mins; Positive results: as soon as 1 min. DO NOT READ AFTER 15 MINS RT for 15 mins; DO NOT READ AFTER 20 MINS
Reading &
Interpretation Result Reading Interpretation Result Reading Interpretation Result Reading Interpretation
(+) Control Negative for Plasmodium Absence of malarial (+) Control Negative for Typhoid IgG Absence of active (+) C Anti-TP Absence of
(-) P.f falciparum and infection (-) IgG and IgM Ab typhoid infection (-) T negative syphilis infection
(-) P.v Plasmodium vivax antigens (-) IgM (+) C Anti-TP Presence of
(+) T positive syphilis infection
(+) Control Positive for Plasmodium Patient has a (+) Control Positive for Typhoid IgG Ab Patient had a previous
(-) C INVALID Repeat test using
(+) P.f falciparum antigen Plasmodium falciparum (+) IgG typhoid infection
a new device
(-) P.v infection (-) IgM

(+) Control Positive for Plasmodium Patient has a (+) Control Positive for Typhoid IgM Ab Patient has an acute
(-) P.f vivax antigen Plasmodium vivax (-) IgG typhoid infection
(+) P.v infection (+) IgM
(+) Control Positive for Plasmodium Patient has a mixed
(+) P.f falciparum and Plasmodium falciparum (+) Control Positive for Typhoid IgG Patient is in the middle
(+) P.v Plasmodium vivax antigens & Plasmodium vivax (+) IgG and IgM Abs stage of a typhoid
malarial infection (+) IgM infection
(-) Control INVALID Repeat test using a new
device (-) Control INVALID Repeat test using a new
device

Confirmatory Presence of Plasmodium spp on thick and thin peripheral blood smear Blood culture FTA-ABS (Fluorescent Treponemal Antibody
Absorption Test

*C = Control; T = Test