Infectious Disease Screening

HIV Rapid Test

Anti-HIV 1/2 Rapid Test

infectious disease screening

Background

The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes the acquired immunodeficiency syndrome (AIDS), a condition in humans in which progressive failure of the immune system.HIV continues to be a major global public health issue, having claimed more than 39 million lives so far. In 2013, 1.5 million people died from HIV-related causes globally.

Racoo Screening HIV Tests:

  • Immuno-chromatographic (Ag-Ab-Ag) sandwich assay
  • CE Certified
  • Qualitative detection of antibodies generated against IgG, IgA and IgM of HIV virus.
  • Detects antibodies generated against all HIV subtypes (HIV Type 1, Type 2, Type O)
  • Detects antibodies generated against p24 Antigen
  • High stability, specificity and sensitivity

Sensitivity: 100%, Specificity: 100%, (+) Predictive V: 100%, (-) Predictive 100%

Product CE Status Type Sample Type Kit Size Additional Materials
anti-HIV ½ TEST CE 1434 Cassette S/P 25 / 50 dropper
anti-HIV ½ TEST CE 1434 Cassette WB/S/P 25 / 50 dropper, diluent (for WB)
anti-HIV ½ TEST N/A Midstream Saliva / WB 1 / 10 / 25 dropper, diluent

 

Specimen type: Serum / Plasma or WholeBlood / Serum / Plasma and Oral fluid (saliva)

Hepatitis Rapid Tests

Anti-HCV Test

infectious disease screening

Background

Hepatitis C is a liver disease caused by the hepatitis C virus: the virus can cause both acute and chronic hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C is found worldwide. The most affected regions are Central and East Asia and North Africa.

Racoo Screening Anti-HCV Tests:

  • Detects antibodies generated against the proteins, encoded by all HCV genotypes’ most conserved parts of Core,  NS3, NS4, NS5 region in HCV genome
  • Qualitative results are to be read visually within 5-15 minutes.

Sensitivity: 100%, Specificity: 100%,  (+) Predictive V: 100%, (-) Predictive 100%

Specimen type: Serum / Plasma or WholeBlood / Serum / Plasma

Product CE Status Type Sample Type Kit Size Additional Materials
anti-HCV TEST CE 1434 Cassette S/P 25 / 50 dropper, diluent
anti-HCV TEST CE 1434 Cassette WB/S/P 25 / 50 dropper,diluent

HBsAg RAPID TEST

infectious disease screening

Background

Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is transmitted through contact with the blood or other body fluids of an infected person.  More than 780 000 people die every year due to the consequences of hepatitis B. Hepatitis B is an important occupational hazard for health workers. Hepatitis B is preventable with the currently available safe and effective vaccine.

Racoo Screening HBsAg Tests:

  • The presence of HBsAg indicates that the person is infectious
  • CE Certified
  • Direct detection of virus antigens and all subtypes of HBsAg so accuracy is high.
  • Qualitative results are to be read visually within 5-15 minutes.
  • Sensitivity: 100%, Specificity: 100%,  (+) Predictive V: 100%, (-) Predictive 100%
  • Cut-off: 0,26 IU/mL (0,5 French ng)

Specimen type: Serum / Plasma or WholeBlood / Serum / Plasma

Product CE Status Type Sample Type Kit Size Additional Materials
HBsAg TEST CE 1434 Cassette S/P 25 / 50 dropper
HBsAg TEST CE 1434 Cassette WB/S/P 25 / 50 dropper

Anti-HBs (HBsAb) RAPID TEST

infectious disease screening

Background

The presence of anti-HBs is generally considered of recovery and immunity from HBV infection. Anti-HBs also may mean that the patient is vaccinated.

Racoo Screening HBsAb Tests:

  • CE Certified
  • Qualitative results are to be read visually within 5-15 minutes.

Sensitivity: 100%, Specificity: 100%, (+) Predictive V: 100%, (-) Predictive 100%

Cut-off: 9 mlU/ml

Specimen type: Serum / Plasma or WholeBlood / Serum / Plasma

Product CE Status Type Sample Type Kit Size Additional Materials
anti-HBs (HBsAb) TEST CE 1434 Cassette S/P 25 / 50 dropper
anti-HBs (HBsAb) TEST CE 1434 Cassette WB/S/P 25 / 50 dropper

Helicobacter Pylori Rapid Tests

H.PYLORI ANTIGEN RAPID TEST

infectious disease screening

Background

Rapid test for the aid of detection to H.Pylori Antigens which may cause some of the gastrointestinal diseases.

Racoo Screening Helicobacter Pylori Antigen Tests:

  • Results in 5- 15 minutes
  • 99% overall compliance with ELISA
  • Sandwich method rapid lateral flow test
  • Clean, Ease of use with the sample collection tube with diluent.

Sensitivity: 99.9%, Specificity: 99.9%,

(+) Predictive V: 99.9%, (-) Predictive V: 99.9%, Confidence Interval: 95.0%

 

Product CE Status Type Sample Type Kit Size Additional Materials
H.PYLORI Ag TEST CE Cassette Stool 25 sample collection tube

H.PYLORI ANTIBODY RAPID TEST

infectious disease screening

Background

Rapid test for the aid of detection to Antibodies generated against H.Pylori  antigens which may cause some of the gastrointestinal diseases.

Racoo Screening Helicobacter Pylori Antibody Tests:

  • Results in 5- 15 minutes
  • 99% overall compliance with ELISA
  • Sandwich method rapid lateral flow test
  • Sensitivity: 99.0%, Specificity: 93.4%,
  • (+) Predictive V: 96.4%, (-) Predictive V: 98.0%, Confidence Interval: 95.0%

Sensitivity: 99.9%, Specificity: 99.9%,

(+) Predictive V: 99.9%, (-) Predictive V: 99.9%, Confidence Interval: 95.0%

 

Product CE Status Type Sample Type Kit Size Additional Materials
H.PYLORI Ag TEST CE Cassette Stool 25 sample collection tube
Product CE Status Type Sample Type Kit Size Additional Materials
H.PYLORI Ab TEST CE Cassette S/P – WB 25 dropper

STREP A Rapid Test

infectious disease screening

Background

Rapid test for the detection of Streptococcus Type A bacterium.

Racoo Screening Strep A Tests:

  • Fast and easy detection
  • Sandwich method lateral flow assay
  • Positive and negative controls are included in kit.
  • Work station and test tubes are also provided with kit.

Sensitivity: 97.3%, Specificity: 99.0%,

(+) Predictive V: 98.6%, (-) Predictive V: 97.5%, Confidence Interval: 95.0%

Product CE Status Type Sample Type Kit Size Additional Materials
STREP A TEST CE Cassette Throat Swab 25 Swab, Reagents, +/- controls,dropper

Rotavirus Rapid Test

Rotavirus Denovirus Rapid Test infectious disease screeningBackground

Qualitative Rotaovirus detection in human feces.

Racoo Screening Strep A Tests:

  • Results in 5- 15 minutes
  • Fast and accurate results.
  • Sandwich method lateral flow rapid test.
  • Clean easy and reliable use.

Sensitivity: 99.99%, Specificity: 99.0%,

(+)Predictive V: 99.0%, (-) Predictive V: 99.99%, Confidence Interval: 95.0%

 

Product CE Status Type Sample Type Kit Size Additional Materials
ROTAVIRUS TEST CE Cassette Stool 25 sample collection tube

Adenovirus Rapid Test

infectious disease screening

Background

Qualitative Adenovirus detection in human feces.

Racoo Screening Adenovirus Tests:

  • Easy and accurate diagnosis.
  • Results in 5- 15 minutes
  • Sandwich method lateral flow rapid test
  • Easy, Clean and reliable use.

Sensitivity: 99.9%, Specificity: 99.3%,

(+)Predictive V: 99.0%, (-) Predictive V: 99.9%, Confidence Interval: 95.0%

 

Product CE Status Type Sample Type Kit Size Additional Materials
ADENOVIRUS TEST CE Cassette Stool 25 sample collection tube

Malaria Rapid Tests

malaria screening infectious disease screening

Background

Used for qualitative detection and differentiation of P.f (HRP-II) and P.f., P.v., P.o., P.m. (Pan – malarial aldolase antigens)

Racoo Screening Malaria Tests:

  • One step lateral flow rapid test.
  • Detects 4 different types of parasites
  • At P.f line  P. Falciparium is detected and at Pan çizgisinde, P. Malaria, P. Ovale ve P. Vivax are detected.
  • P.f. and Pan results are shown in seperate lines.
  • 95% Confidence Interval

For Pan Relative Sensitivity >99.9% (158/158) (97.6%~100%)

For P.f Relative Sensitivity > 99.9% (53/53) (93%~100%)

Relative Specificity: 99.1% (324/327) (97.3%~99.8%)

Accuracy : 99.4% (538/538) (98.3%~99.8%)

Product CE Status Type  Sample Type Kit Size  Additional Materials
MALARIA TEST CE Cassette WB 25 dropper, diluent

Tuberculosis (TB) Rapid Test

infectious disease screening

Background:

Used for the qualitative detection of TB antibodies generated against Mycobacterium tuberculosis antigens

Racoo Screening TB Tests:

  • IgA, IgM and IgG are fully detected
  • Isotypes of TB is fully detected

Sensitivity: 85%, Specificity: 99%,

(+) Predictive V: 96.1%, (-) Predictive V: 96%

Product CE Status Type  Sample Type Kit Size  Additional Materials
TUBERCULOSIS (TB) TEST CE Cassette WB/S/P 25 drooper, diluent