QuikRead go Strep A

When a patient presents with a sore throat (acute pharyngitis), it can be difficult to differentiate, based on visual inspection only, whether the infection is caused by Strep A or by viruses. QuikRead go Strep A is an easy to use and fast diagnostic test which reliably detects Strep A from a throat swab sample. It provides quick and accurate results during consultation, identifying those patients who need treatment with antibiotics. The test result – positive or negative – is displayed on the instrument, thus eliminating the uncertainty and subjectivity associated with visual assessment of the test result.

QuikRead go Strep A provides you with

Fast and objective results

• Clear positive and negative samples in less than two minutes, all results in less than four minutes measurement time

Flexibility

• Performing the test and recording the results are easily adapted to user workflow

Traceable results

• Results are automatically stored in the instrument’s memory and user and/or patient information can be stored with the results.
• The instrument is connectable to HIS/LIS systems

Test results should never be used alone, without a complete clinical evaluation.

QuikRead go Strep A is not registered in the USA.

Acute pharyngitis is one of the most common reasons for seeking medical attention in primary care. Most cases of acute pharyngitis are caused by viruses. The most common bacterial cause is Streptococcus pyogenes, also known as Strep A. Strep A infection is the only commonly occurring form of sore throat warranting antibiotic treatment. As the signs and symptoms of Strep A infection and those of pharyngitis caused by other micro-organisms (mostly viruses) often overlap, it is difficult to rule out Strep A infection on clinical grounds alone.

Although most cases of sore throat are benign and self-limiting, infections caused by Streptococcus pyogenes, Strep A, require antibiotic treatment.

Specific features of sore throat and Strep A

• Sore throat is usually due to an inflammatory response to viral or bacterial infection.
• Most cases of sore throat are caused by viruses.
• Of bacteria, Strep A is the most likely causative organism.
• Strep A sore throat affects mainly children and young adults.
• Symptoms of Strep A infection and those caused by other micro-organisms often overlap.
• Antibiotic therapy reduces the duration of symptoms.
• The amount of antibiotic prescriptions due to Strep A sore throat exceeds by far the expected prevalence of this infection.

As the signs and symptoms of Strep A infection and those of pharyngitis caused by other micro-organisms (most commonly viral) often overlap, it is difficult to make an diagnosis on clinical grounds only.
To avoid inappropriate antibiotic treatment of large numbers of patients with pharyngitis, it is important to verify or exclude Strep A infection. The diagnosis should be based on clinical and epidemiological data supported by laboratory tests.

Use of throat sample culture is an accurate and sensitive diagnostic way for finding out if Strep A is the cause for pharyngitis. The culture, however, takes time and the result is available only next day. Strep A rapid antigen tests are easy to use and reliable enough for primary care use to support the decision to prescribe antibiotics while the patient is at the doctor.

Del Mar CB et al. Antibiotics for sore throat (Cochrane review). In:The Cochrane library, Issue2, 2004. Chichester, UK: John Wiley & Sons Ltd.

Bisno AL, Peter GS, Kaplan EL. Diagnosis of Strep throat in adults: Are Criteria Really Good Enough? Clin Infect Dis 2002; 35: 126 - 129.

Ebel MH et al.The rational clinical examination. Does This Patient Have Strep A Throat? JAMA 2000; 284: 2912 - 2918.

Bisno AL, Gerber MA, Gwaltney JM Jr, Kaplan EL, Schwartz RH. Practise Guidelines for the Diagnosis and Management of Group A Streptococcal Pharyngitis. CID 2002; 35(2); 113 - 125.

Bisno AL. Acute pharyngitis. N Engl J Med 2001; 344(3): 205 - 211.

Cooper RJ et al. Principles of Appropriate Antibiotic Use for Acute Pharyngitis in Adults: Background. Ann intern Med 2011; 134(6): 509 - 517.

Snow V et al. Principles of Appropriate Antibiotic Use for Acute Pharyngitis in Adults: Background. Ann intern Med 2011; 134(6): 506 - 508.

Linder JA, Stafford RS. Antibiotic Treatment of Adults With Sore Throat by Community primary Care Physicians: A National Survey, 1989 - 1999. JAMA 2001; 286(16): 1181 - 1186.

Linder JA et al. Antibiotic Treatment of Children With Sore Throat. JAMA 2005; 294 (18): 2315 - 2322.

Snellman LW et al. Duration of Positive Throat Cultures for Group A Streptococci After initiation of Antibiotic Therapy. Pediatrics, 1993; 91: 1166 - 1170.

Gulich MS et al. Improving diagnostic accuracy of bacterial pharyngitis by near patient measurement of C-reactive protein (CRP). Br Gen Pract 1999; 49: 119 - 121.

QuikRead go Strep A Brief Instructions (EN)

QuikRead go Family Brochure (EN)

QuikRead go Technical Specifications (EN)

QuikRead go Control Information (EN)

QuikRead go Strep A Poster ESPID 2013 (EN)

Stories

Strep A in primary healthcare (EN)

Videos

QuikRead go Strep A Test Procedure Video (EN)

Video on YouTube: QuikRead go Strep A Test Procedure

Instructions for use

(For informative use only. Kindly always refer to the latest package insert in the kit.)

QuikRead go Strep A IFU (FI, SE, NO, DK), 135883

QuikRead go Strep A IFU (GB, DE, FR, IT), 135883

QuikRead go Strep A IFU (SI, RS, HR, GR), 135883

QuikRead go Strep A IFU (CZ, SK, HU, PL), 135883

QuikRead go Strep A IFU (ES, PT, NL, RU), 135883

Safety Data Sheet

QuikRead go Strep A SDS (EN)

Are the results affected if I do not use the swab intended for the QuikRead go Strep A kit?

Yes. It is very important to use the swabs intended for the kit as other types of swab may cause false results. Some swabs contain substances which may inhibit the reaction and cause false negative results, whereas other swabs may affect the buffer volume causing either a false positive or negative result.

Why do I have to observe the colour changes during the extraction and after adding the sample into the prefilled cuvette?

The Extraction Reagent 2 contains a pH indicator which helps you to ensure that the test procedure is correct. The extraction solution must be acidic (yellow-orange colour) and the acid has to be neutralised (pink) by the buffer in the cuvette before addition of the reagent.

Do I have to update the QuikRead go instrument software to be able to use the QuikRead go Strep A kit?

The QuikRead go Strep A kit can be used in QuikRead go instruments with software version 4.1 or later.

Is it possible to order extra swabs for the test?

QuikRead go Strep A swabs are available in a pouch including 50 single packed swabs.
Each swab is CE-marked and the product can be delivered to the European Economic Area (EEA) countries. The product number for the QuikRead go Strep A swab pouch is 153292.