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The microalbumin test is an immune-chemical lateral flow test for the semi-quantitative detection of small quantities of albumin in urine.

Within a concentration range of 20 mg/L – 100 mg/L the color intensity of the test result line decreases continuously, so that the albumin quantity can be read off on the basis of a color scale. 

Relative Sensitivity: >99.9% (95%CI*: 96.3%-100%)

Relative Specificity:83.3% (95%CI*: 71.5%-91.7%)

Accuracy: 92.9% (95%CI*:87.3%-96.5%)

* Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of Clostridium difficile bacteria, Toxin A and Toxin B in feces. 

Clostridium Difficile: 

Relative sensitivity: 75/75=100% (95% CI: 96.08% ~ 100%)*

Relative specificity: 226/243=93.00% (95% CI:89.0% ~ 95.87%)*

Accuracy: (75+226)/(75+226+17)=94.7% (95% CI:91.58% ~ 95.87%)*

Toxin A 

Relative sensitivity: 32/33=96.97% (95% CI: 84.24% ~ 99.92%)*

Relative specificity: 47/49=95.92% (95% CI:86.02% ~ 99.50%)*

Accuracy: (32+49)/(32+1+2+47)=98.78% (95% CI:93.39% ~ 99.97%) *

Toxin B 

Relative sensitivity: 52/54=96.30% (95% CI: 87.25% ~ 99.54%)*

Relative specificity: 40/44=90.91% (95% CI:78.33% ~ 97.46%)*

Accuracy: (52+40)/(52+2+4+40) =93.88% (95% CI:87.15% ~ 97.72%)*

*Confidence Intervals 

Rapid immunochromatographic test for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Nasal Swab Specimen:

Relative sensitivity: Influenza A 94.7%, Influenza B 81.0%*

Relative specificity: Influenza A 95.4%, Influenza B 98.8%*

Accuracy: Influenza A 95.8%, Influenza B 95.3%*

Throat Swab Specimen:

Relative sensitivity: Influenza A 69.2%, Influenza B 90.9%*

Relative specificity: Influenza A 94.0%, Influenza B 95.7%*

Accuracy: Influenza A 90.0%, Influenza B 95.0%*

Nasal Aspirate Specimen:

Relative sensitivity: Influenza A 88.1%, Influenza B 96.2%*

Relative specificity: Influenza A 93.0%, Influenza B 97.5%*

Accuracy: Influenza A 91.3% Influenza B 97.1%*

Overall Specimen:

Relative sensitivity: Influenza A 86.8%, Influenza B 91.7%*

Relative specificity: Influenza A 94.0%, Influenza B 97.5%*

Accuracy: Influenza A 92.2% Influenza B 96.1%*

*Confidence Intervals 

Rapid immunochromatographic test for the qualitative detection of SARS-CoV-2 antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

Relative sensitivity: 90.1% (95% CI*:82.5%~95.1%)

Relative specificity: 99.3% (95% CI*: 97.7%~99.9%)

Accuracy: 97.0% (95% CI*: 94.9%~98.5%)

*Confidence Intervals 

Rapid immunochromatographic test for the qualitative detection of multiple drugs and drug metabolites in urine at the following drugs: AMP/BAR/BZO/BUP/COC/THC/MTD/MET/MDMA/MOP/TCA/FYL Including Specimen Validity Tests (S.V.T.) for: Oxidants/PCC, Specific Gravity, pH, Nitrite, Glutaraldehyde, Creatinine and Bleach.

Rapid immunochromatographic test for the qualitative detection of Rotavirus and Adenovirus antigens in human feces specimens to aid in the diagnosis of rotavirus or adenovirus infection.

Rotavirus:

Relative Sensitivity: 97.3% (95% CI:*94.5%-98.9%)

Relative Specificity: 97.1% (95% CI:*94.2%-98.8%)

Relative Accuracy: 97.2% (95% CI:*95.4%-98.5%) 

Adenovirus:

Relative Sensitivity: 95.2% (95% CI:*89.8%-98.2%) 

Relative Specificity: 97.7% (95% CI:*95.0%-99.1%) 

Relative Accuracy: 96.8% (95% CI:*94.6%-98.4%)

*Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of Human Occult Blood in feces.

Relative sensitivity: 189/199=95% (95% CI*: 91%~97.6%);

Relative specificity: 802/806=99.5% (95% CI*: 98.7%~99.9%);

Accuracy: (189+802)/(189+10+4+802) =98.6% (95% CI*: 97.7%~99.2%).

*Confidence Intervals

Rapid immunochromatographic test for the qualitative detection of Strep A antigens from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

Relative Sensitivity: 95.1% (95% CI*: 89.6%-98.2%) 

Relative Specificity: 97.8% (95% CI*: 95.8%-99%)

Accuracy: 97.1% (95% CI*: 95.3%-98.4%)

*Confidence Intervals 

Multiwell, 96 wells (microplate), U-shape bottom, without lid, PS material, 1 piece.

Pipettes Pasteur, sterile, 150 mm length, 5ml volume, graduated, 1 box x 100 ps.

Containers for specimen - 60 ml, urine, sterile, blue screw cap, with label, individually wrapped, graduated at: 10, 20, 30, 40, 50, 60 ml, 1 piece.

Microtubes Eppendorf type - Polyprolyne (PP) microtube 2,0 ml, neutral colour, 10,3 x 40,5 mm, round bottom, autoclavable, with flat cap and frosted label, one-handed usage, rezistant at centrifugation 10.000G and temperatures from - 86 °C to +121 °C, 1 box x 100 ps.

Microscope cover glass - 24 x 24 mm, thickness 0.13-0,16 mm, 1 box x 100 ps.

The TPHA (Treponema Pallidum Haemagglutination Assay) test kit is for the detection of antibodies to T. pallidum (Syphilis) in human serum based on haemagglutination.

The RPR (Rapid Plasma Reagin) test is a non-treponemal method for the serological detection of syphilis. The antigen – a particulate carbon suspension coated with lipid complexes – agglutinates in the presence of serum reagins. Reagins are antibodies present in the serum of syphilitic patients. Visible agglutination in the form of black clumps which can be viewed macroscopically, indicate the presence of such antibodies in the sample tested.

Sensitivity of over 99%.