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FOB Rapid Test CE

Features:
  • Designed to specifically detect low levels of fecal occult blood, hHB ≥ 50 ng/mL
  • Higher accuracy, sensitivity and specificity than the Guaiac Test
  • No dietary restrictions
  • Clear, easy-to-interpret result
  • Individually sealed foil pouches containing:
    • One cassette test device.
    • One desiccant
  • Stool collection devices, each containing 2 mL of extraction buffer (REF SB-R2010)
  • Patient ID stickers
  • One package insert (instruction for use)
  • CATALOG # PRODUCT QUANTOTY SPECIMEN

    R2010C

    FOB Rapid Test

    25/kit

    Fecal

MAU FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 2.0-300.0 mg/L
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of MAU reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of MAU reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY:
  • MAU control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY:
  • A serial concentration of MAU reference materials at 2.0-300.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.
  • REAGENTS AND MATERIALS PROVIDED:
    1. Individually sealed foil pouches containing: a. One test device b. One desiccant
    2. Detection buffer tubes
    3. SD card
    4. Instructions for Use
    MATERIALS REQUIRED BUT NOT PROVIDED:
    1. Clock or timer
    2. RaFIA Immunofluorescence Analyzer
    3. RaFIA Immunofluorescence Incubator
CATALOG # PRODUCT QUANTITY SPECIMEN

F2020

MAU FIA Test

25/kit

Urine

Hemaray 86

Features:
  • 28 Parameters, 2 Histograms, 2 Scattergrams
  • Laser Scatter Technology
  • 3-D Topographic Maps for WBC
  • Cyanide Free reagent
  • Constant Linear Sheath Flow
  • Integral Titanium Incubation System
  • 2 test modes & 2 sample modes
  • Autoloader
  • Throughput: 60 samples/hour
 

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COVID-19 Ab Rapid Test

Features:
  • The OnSite COVID-19 Ab Rapid Test is designed to detect anti-SARS-CoV-2 total antibodies in either serum, plasma or whole blood within 15 minutes. It is presumed that the OnSite COVID-19 Ab Rapid Test may detect SARS-CoV-2 in other species of mammals including mink.
  • This test is easy to use and does not require the use of laboratory equipment.
  • REAGENTS AND MATERIALS PROVIDED
    1. Individually sealed foil pouches containing:
      1. One cassette device
      2. One desiccant
    2. Disposable capillary tubes, marked for 10 µL and 20 µL
    3. Detection buffer (tris-based buffered solution with preservatives)
    4. Instructions for Use
    MATERIALS REQUIRED BUT NOT PROVIDED
    1. Clock, watch or other timing device
    2. Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy
    3. Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens
    4. Collection devices for venous whole blood, serum, plasma
    5. Disposable gloves, biohazard disposal container
CATALOG # PRODUCT QUANTITY SPECIMEN

R0185C

COVID-19 Ab Rapid Test

30/kit

S, P &WB
 

Cys-C FIA Test

Features:
    • Quantitative, non-subjective results
    • Increased sensitivity and broader detection range compared to rapid tests
    Range
    • Working range: 0.2-8.0 mg/L
    Precision Intra-lot Precision
    •  Intra-lot precision was determined by testing of Cys-C reference materials using 10 test devices from the same lot. CV ≤ 15%.
    Inter-lot Precision
    • Inter-lot precision was determined by testing of Cys-C reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
    Accuracy
    • Cys-C control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
    Linearity
    • A serial concentration of Cys-C reference materials at 0.4-8.0 mg/L was tested, and the correlation coefficient (R) is ≥ 0.9900.
      1. Individually sealed foil pouches containing:
        1. One test device
        2. One desiccant
      2. Detection buffer tubes
      3. SD card
      4. Instructions for Use
      Materials required but not provided:
      1. Clock or timer
      2. RaFIA Immunofluorescence Analyzer
      3. RaFIA Immunofluorescence Incubator
 

Dengue Ag Rapid Test CE

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: 98.8% 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), Creatinine (442 µmol/L), 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)
  • Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 200 μg/mL during the study.
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0063, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0063C

Dengue Ag Rapid Test CE

30/kit

S, P &WB

DiaSys Respons 940

Features:
  • System Type: Automated random access clinical chemistry analyzer
  • Throughput: 400 test per tests, independently for mono and two component reagents
  • Sample disk: 80 positions for samples, blanks, standards, calibrators, controls, STAT samples
  • Reagent on-board capacity: 72 reagent positions (R1+R2), refrigerated
  • Reaction Unit: 72 permanent hard glass cuvettes (37 ± 0.2°C)
  • Photometry: 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700 and 705 nm)

TORCH Panel Rapid Test

Features:
    • Distinguishes between IgG and IgM in all five TORCH infections
    • Compatible with serum, plasma, and whole blood
    • Results available in 15 minutes
    • Provides semi-quantitative results for Rubella IgG antibodies
    • Distinguishes between HSV-1 and HSV-2
    • Shelf life: 18 months
    • Analytical Sensitivity of IgG Detection: Twenty negative specimens were spiked with appropriate reference standards at various concentrations. Specimens were run on the OnSite TORCH Panel Rapid Test panel member. Defined as the 95% detection level, the limits of detection, or sensitivity, were determined to be as follows:
    1. Toxo: 5 IU/mL LOD; WHO International Standard Anti-Toxoplasma Serum Ig (TOXM)
    2. Rubella: 15 IU/mL (G1); 250 IU/mL (G2); WHO 1st International Standard (RUBI-1-94)
    • Accuracy of IgG Detection in comparison with commercial ELISA: Clinical IgG positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial ELISA. Comparison for all subjects showed the following overall agreements:
    1. Toxo (237 specimens): 94.9%
    2. Rubella (214 specimens): 97.7%
    3. CMV (258 specimens): 93.4%
    4. HSV-1 (227 specimens): 90.7%
    5. HSV-2 (214 specimens): 95.3%
    • Accuracy of IgM Detection in comparison with commercial ELISA: Clinical IgM positive specimens  were collected and tested on each OnSite TORCH Panel Rapid Test  panel  member  as  well  as  by  commercial    Comparison  for  all  subjects  showed  the following overall agreements:
    1. Toxo (231 specimens): 98.8%
    2. Rubella (25 specimens): 96.0%
    3. CMV (212 specimens): 93.9%
    4. HSV-1 (107 specimens): 85.0%
    5. HSV-2 (26 specimens): 95.2%
    • Cross Reactivity: No false positive IgG and IgM results were observed on 3-14 specimens from the following disease states or special conditions, respectively: Toxo, Rubella, CMV, HSV-1, HSV-2, hCG, HAV, HBV, HCV, HEV, HIV, TB, palladium, Dengue, Malaria, H. pylori, Typhoid, ANA, HAMA, and RF (>1,000 IU/mL).
    During cross-reactivity testing for each TORCH infection, self-reactivity was not considered (i.e. rubella positive samples were not tested on the Rubella IgG/IgM Rapid Test). Specimens tested vary for each panel member of the OnSite TORCH Panel Rapid Test.
    • Interference: No interference was seen from the following substances: Albumin 60 g/L; Bilirubin 20 mg/dL; Heparin 3,000 U/L; Hemoglobin 2 g/L; Creatinine 442 µmol/L; EDTA 3.4 µmol/L; Salicylic acid 4.34 mmol/L; Glucose 55 mmol/L; and Sodium citrate 3.8%.
  • Individually sealed foil pouches containing:
    • One cassette device
    • Two desiccants
  • Plastic droppers
  • Sample diluent (REF SB-R0253, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0253C

TORCH Panel Rapid Test

10/kit

S,P& WB