Raj Biosis Private Limited

• Instant screening test

• Detects IgM anti-HAV in serum, plasma and whole blood

• Evaluated with BBI seroconversion panel (PHT903)

• Useful for identifying acute HAV infections

Product Features:

• In-house developed fourth-generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection

• Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen

• Simple assay procedure yields results within 20-25 minutes

Clinical Performance:

• Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)

• Sensitivity: 100%

• Specificity: 98.75% comparing to a commercial ELISA

• Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others

• No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)

• Use of conserved antigens allows ‘pan-filaria’ tests to be applicable

• Simple procedure provides alternative to diagnosis by blood smear

• Use serum, plasma or whole blood

• No restrictions on time of day for sample collection

The TRUSTline HCV Ab Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood.

• Utilizes a Core-NS3-NS4-NS5 double antigen method

• Evaluated by NIB

• Highly sensitive detection of low level titre antibodies

• Simple test procedure

• Efficient, easy-to-interpret result

• No equipment required

• Highly sensitive diagnostic test: Detects and monitors AFP levels for various conditions, including cancer.
• Chemiluminescence immunoassay: Uses a chemical reaction to produce light, enhancing sensitivity and precision.
• Multi-purpose: Suitable for various clinical applications, including routine testing, special tests, and emergent care.
• Rapid results: Provides quick results for timely diagnosis and treatment decisions.
• Multiple tests: Can be used with various Maglumi reagents for different assays.
• Workflow improvement: Streamlines the testing process and reduces manual

SD BIOLINE Rota/Adeno Ag test is a rapid immunochromatographic assay for qualitative detection of the presence of rotavirus or adenovirus antigen in human fecal specimens.

• Differentiation of test results by clear band formation (3-line)
• Test result : 20min
• Specimen : Fecal specimens(about 50mg)
• 24 months at 1-30°C

SD BIOLINE Norovirus rapid test is a rapid immunochromatographic assay for qualitative detection of the presence of norovirus antigen (Geno group I (GI) and Geno group II(GII)) in human fecal specimens. It is used as an aid in the diagnosis of acute gastroenteritis with the symptoms of suspected gastroenteritis caused by Norovirus. 

• Specimen : Fecal specimens (50-100mg)
• Test result : 15min
• 24 months at 1-30°C

SD BIOLINE Influenza Ag test detects Influenza virus type A & B respectively. Also, it detects all kinds of influenza antigen subtypes including novel influenza A(H1N1) pandemic strain.

Differential detection of Influenza virus type A & B

Human nasal swab, throat swab, nasopharyngeal swab or nasal/nasopharyngeal aspirate

Sensitivity (91.8%), specificity 99.0% vs. Viral culture and RT-PCR as gold standard

A lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human serum or plasma.

• Detects IgG, IgM and IgA antibodies facilitating accurate screening during all stages of disease

• Simple test procedure

• Efficient, easy to interpret result

• No additional equipment required

• Room temperature storage

• Utilizes Recombinant Orientia tsutsugamushi antigens.

• Qualitative detection and differentiation of antibodies(IgG and IgM) against Orientia tsutsugamushi (Scrub typhus)

• Compatible with Whole blood, Serum and Plasma.

• Sensitivity: For IgG 95.4% and IgM 96.1%, Specificity: For IgG 96.8% and IgM 97.6%.

• Results in 20 minutes.

• Uses serum, plasma or whole blood specimen

• Utilizes recombinant antigen derived from the CHIK structure protein

• IgM immunoassay is the most practical lab method

• Distinguish from dengue infection which presents with similar symptoms

• Meets WHO acceptance criteria

• Ease of use, requires minimal training of personnel

• Expanded testing facility options including areas where quality microscopy is not available

• Quick turnaround time to results

• Increased cost effectiveness, no high cost equipment monitoring

• Availability of Positivia external controls

• Utilizes O antigen and H antigen from both Typhi and Paratyphi serovars to maximize sensitivity

• Differentiates between IgG and IgM to determine stage of infection

• One step procedure minimizes operator error due to sample preparation

• Test result within 15 minutes allows medical professionals to take immediate action

• High level of reproducibility

• Test kits can be used and stored in a wide range of temperatures

Each Kit Contains:

• Individually sealed foil pouches containing:

  • One cassette device.

  • One desiccant

• Plastic droppers

• Sample Diluent (1 bottle, 5 mL)

• One package insert (instruction for use)

A lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM, and IgA) to Treponema pallidum (Tp) in human serum or plasma.

• Detects IgG, IgM, and IgA antibodies facilitating accurate screening during all stages of disease

• Simple test procedure

• Efficient, easy-to-interpret result

• No additional equipment required

• Room temperature storage

• Utilizes recombinant chimeric dengue virus licensed from the US CDC

• Detects all four dengue serotypes

• Duo test format minimizes processing time

• IgM detection indicates recent infection

• IgG detection indicates recent or previous infections

• Ag detection indicates a current infection

• Utilizes O antigen and H antigen from both Typhi and Paratyphi serovars to maximize sensitivity

• Differentiates between IgG and IgM to determine stage of infection

• One step procedure minimizes operator error due to sample preparation

• Test result within 15 minutes allows medical professionals to take immediate action

• High level of reproducibility

• Test kits can be used and stored in a wide range of temperatures

Each Kit Contains:

• Individually sealed foil pouches containing:

  • One cassette device.

  • One desiccant

• Stool collection devices, each containing 1 mL Fecal Sample Extraction Buffer

• Plastic droppers

• Patient ID stickers

• Sample Diluent (1 bottle, 5 mL)

• One package insert (instruction for use)

A lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to anti-HIV-1 & 2 virus and HIV-1 p24 antigen in human serum, plasma, or whole blood.

• 4th Generation HIV test to detect p24 in addition to IgG and IgM for early detection

• Evaluated by NIB

• Requires only 5 µL of specimen

• Use serum, plasma, or whole blood

• Results available within 15 min to allow prompt action to be taken at the point of care

• Performance validated with BBI low titre panel and Chinese FDA HIV Ab Panel

• Use of conserved antigens allows ‘pan-filaria’ tests to be applicable

• Simple procedure provides alternative to diagnosis by blood smear

• Use serum, plasma or whole blood

• No restrictions on time of day for sample collection

• Instant screening test

• Detects IgM anti-HAV in serum, plasma and whole blood

• Evaluated with BBI seroconversion panel (PHT903)

• Useful for identifying acute HAV infections

A lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma at a level equal to or higher than 0.5 ng/mL.

• Uses serum or plasma

• Evaluated by NIB

• Can be performed without the use of laboratory equipment

• Result in 15 minutes

The TRUSTline HCV Ab Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood.

• Utilizes a Core-NS3-NS4-NS5 double antigen method

• Evaluated by NIB

• Highly sensitive detection of low level titre antibodies

• Simple test procedure

• Efficient, easy-to-interpret result

• No equipment required

• Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market

• Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA

• Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 µmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 µmol/L; Hemoglobin: 2 g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L

• Shelf life: 24 month